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 .
Status of Claims
This office action is responsive to the amendment filed on 06/08/2026. As directed by the amendment: claims 17, 18, 20, 22-24 and 26-33 have been amended, claim 19 has been cancelled and no new claims have been added. Thus, claims 17, 18 and 20-33 are presently pending in this application, and currently examined in the Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 27 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. Both claims 27 and 28 depend from claim 26, which sets forth the second material is “the rhenium base alloy”, however claim 27 sets forth specific chemical percentages for “the molybdenum base alloy”, and claim 28 sets forth specific chemical percentages for “the tungsten base alloy”; this is found to be confusing since it is not clear if the alloy being claimed is directed towards the rhenium base alloy or the molybdenum/tungsten base alloy. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claims indefinite. In order to overcome this rejection, it is suggested both claims 27 and 28 depend from claim 25 instead of claim 26, and that is how the claims shall be interpreted for examination purposes.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 17, 18, 20 and 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over Weber et al. (US PG Pub. 2012/0059455), as previously disclosed, hereinafter Weber.
Regarding claims 17, 18 and 20, Weber discloses a stent (20), illustrated in Figure 1, for use in the interventional treatment of vascular diseases/surgery, in which a tubular support structure, which is formed of struts (22) that are connected to one another at selective points (24) and made of a first bioresorbable metallic material; and a completely covering coating (82), which is produced with a second bioresorbable metallic material, is created on a surface of the struts (22) to completely enclose the first bioresorbable metallic material, the second metallic material having a lower dissolution rate under physiological conditions when implanted during bioresorption and a more positive electrode potential compared to the first metallic material ([0005]; [0008]; [0010]; [0033] & [0034] – to clarify, it is stated the first metallic material is a magnesium alloy and the second metallic material of the coating can be tungsten (W); which is well known in the art to have a lower dissolution rate and more positive electrode potential than magnesium alloys/alloys listed), wherein the surface of the struts (22), which are made of the first bioresorbable metallic material, is partially or completely provided with a surface structuring produced by/comprises a periodically recurring pattern of depressions, comprising grooves/troughs/valleys, and elevations, comprising peaks, wherein a surface area of the struts (22) is increased with the surface structuring compared to an electropolished surface of the struts, illustrated in Figure 5A; and though it is not specifically stated the increase in surface area is by a factor of 1.1 to 10, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive, step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate increase in surface area, due to the surface structuring/pores, including by a factor of 1.1 to 10, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to, the parameter of the surface area, of the struts with surface structuring, being increased specifically by a factor of 1.1 to 10, compared to an electropolished surface, as opposed to being increased by any other factor.
Regarding claim 29, Weber discloses the stent according to claim 17, and though it is not specifically disclosed that the second metallic material is pure molybdenum and the first metallic material is tungsten or a tungsten alloy with Mo, Ta, Nb and/or Mn, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive, step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate materials for the first and second metallic materials, including the second metallic material being pure molybdenum and the first metallic material being tungsten or a tungsten alloy with Mo, Ta, Nb and/or Mn, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to, the parameter of the second metallic material being pure molybdenum and the first metallic material being tungsten or a tungsten alloy with Mo, Ta, Nb and/or Mn, as opposed to any other materials/material combinations.
Regarding claim 30, Weber discloses the stent according to claim 17, wherein a sum of a volume of the second metallic material (volume of layer 82) is less than the volume of the first metallic material (volume of core stent 22) that is used to produce the stent struts, illustrated in Figure 5B.
Regarding claims 31 and 32, Weber discloses the stent according to claim 17, wherein the coating is created with a layer thickness in the range of 1 nm to 1000 nm, more specifically 1 nm to 50 nm ([0008], Lines 1-3).
Regarding claim 33, Weber discloses the stent according to claim 17, wherein a layer thickness of the coating on the surface of the struts is irregular across the surface of the struts ([0043]).
Claims 21, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Weber as applied to claim 17 above, and in view of Jansen et al. (US PG Pub. 2003/0181972), as previously disclosed, hereinafter Jansen.
Regarding claims 21, 22 and 24, Weber discloses the stent according to claim 17, but does not specifically teach the first metallic material is a tungsten alloy comprising at least 50 at.% tungsten and greater than 0 at.% to 37 at.% rhenium (Re).
However, Jansen teaches a stent, in the same filed of endeavor, comprising a tungsten alloy comprising at least 50 at.% tungsten and greater than 0 at.% to 37 at.% rhenium (Re); the tungsten alloy allowing for MRI compatibility ([0009] & [0024]).
In view of the teachings of Jansen, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the first metallic material, of the stent of Weber, to comprise a tungsten alloy comprising at least 50 at.% tungsten and greater than 0 at.% to 37 at.% rhenium (Re), in order to allow the stent to be MRI compatible, as taught by Jansen.
Claims 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Weber as applied to claim 17 above, and in view of Roth (US PG Pub. 2019/0046684), as previously disclosed.
Regarding claims 21-23, 25 and 27, Weber discloses the stent according to claim 17, but does not specifically teach the first metallic material is a molybdenum alloy comprising at least 50 at.% molybdenum (Mo) and greater than 0 at.% to less than 50 at.% tungsten (W), tantalum (Ta) and/or niobium (Nb), and/or and greater than 0 at.% to 42 at.% rhenium (Re); and the second metallic material is a molybdenum alloy having greater than 0% to 42% rhenium (Re), wherein the content of rhenium (Re) in the second metallic material is greater than the rhenium (Re) in the first metallic material.
However, Roth teaches a stent being made, and/or having a coating, of a molybdenum alloy comprising at least 50 at.% molybdenum (Mo) and greater than 0 at.% to less than 50 at.% tungsten (W), tantalum (Ta) and/or niobium (Nb), and/or and greater than 0 at.% to 42 at.% rhenium (Re); such molybdenum alloys can provide improved properties such as strength, durability, hardness, biostability, bendability, radial strength, flexibility, tensile strength/elongation, radiopacity, biocompatibility, improved fatigue life, etc. ([0003], Last 2 Lines; [0004]; [0011], Lines 1-3; [0013] & table(s) after [0023] – to clarify, Ex. 14 of the Mo alloy has 5-40 at.% Re, while the rest have 0-40 at.% Re; thus the alloy of Ex. 14 comprises at least 5 at.% Re, while the alloy(s) could comprise less Re at 0.001 at.%-4.999 at.%).
In view of the teachings of Roth, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the first metallic material, of the stent of Weber, to comprise a molybdenum alloy comprising at least 50 at.% molybdenum and greater than 0 at.% to less than 50 at.% tungsten (W), tantalum (Ta) and/or niobium (Nb), and/or and greater than 0 at.% to 42 at.% rhenium (Re), and for the second metallic material is a molybdenum alloy having greater than 0 at.% to 42 at.% rhenium (Re), wherein the content of rhenium (Re) in the second metallic material is greater than the rhenium (Re) in the first metallic material, in order to improved stent properties such as strength, durability, hardness, biostability, bendability, radial strength, flexibility, tensile strength/elongation, radiopacity, biocompatibility, improved fatigue life, etc., as taught by Roth.
Regarding claims 21, 22, 24, 25 and 28, Weber discloses the stent according to claim 17, but does not specifically teach the first metallic material is a tungsten alloy comprising at least 50 at.% tungsten (W) and greater than 0 at.% to less than 50 at.% molybdenum (Mo), tantalum (Ta) and/or niobium (Nb), and/or and greater than 0 at.% to 37 at.% rhenium (Re); and the second metallic material is a tungsten (W) alloy having greater than 0 at.% to 37 at.% rhenium (Re), wherein the content of rhenium (Re) in the second metallic material is greater than the rhenium (Re) in the first metallic material.
However, Roth teaches a stent being made, and/or having a coating, of a tungsten alloy comprising at least 50 at.% tungsten (W) and greater than 0 at.% to less than 50 at.% molybdenum (Mo), tantalum (Ta) and/or niobium (Nb), and/or and greater than 0 at.% to 37 at.% rhenium (Re); and the second metallic material is a tungsten (W) alloy having greater than 0 at.% to 37 at.% rhenium (Re), wherein the content of rhenium (Re) in the second metallic material is greater than the rhenium (Re) in the first metallic material; such tungsten alloys can provide improved properties such as strength, durability, hardness, biostability, bendability, radial strength, flexibility, tensile strength/elongation, radiopacity, biocompatibility, improved fatigue life, etc. ([0003], Last 2 Lines; [0004]; [0011], Lines 1-3; [0014] & table(s) after [0023] – to clarify, Ex. 28 of the W alloy has 5-40 at.% Re, while the rest have 0-40 at.% Re; thus the alloy of Ex. 28 comprises at least 5 at.% Re, while the alloy(s) could comprise less Re at 0.001 at.%-4.999 at.%).
In view of the teachings of Roth, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the first metallic material, of the stent of Weber, to comprise a tungsten alloy comprising at least 50 at.% tungsten (W) and greater than 0 at.% to less than 50 at.% molybdenum (Mo), tantalum (Ta) and/or niobium (Nb), and/or and greater than 0 at.% to 37 at.% rhenium (Re); and the second metallic material is a tungsten (W) alloy having greater than 0 at.% to 37 at.% rhenium (Re), wherein the content of rhenium (Re) in the second metallic material is greater than the rhenium (Re) in the first metallic material, in order to improved stent properties such as strength, durability, hardness, biostability, bendability, radial strength, flexibility, tensile strength/elongation, radiopacity, biocompatibility, improved fatigue life, etc., as taught by Roth.
Regarding claims 25 and 26, Weber discloses the stent according to claim 17, but does not specifically teach the second metallic material is a rhenium base alloy having greater than 0 at.% to 14 at.% of Mo or a content of greater than 0 at.% to 20 at.% of W.
However, Roth teaches a novel alloy which can be used as a coating for a stent, wherein the novel alloy is a rhenium alloy having greater than 0 at.% to 14 at.% of Mo; the novel alloy can provide improved properties such as strength, durability, hardness, biostability, bendability, radial strength, flexibility, tensile strength/elongation, radiopacity, biocompatibility, improved fatigue life, etc. ([0003], Last 2 Lines; [0004]; [0011], Lines 1-3; table(s) after [0023], specifically Ex.15 – Ex. 21).
In view of the teachings of Roth, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the second metallic material, of the stent of Weber, to comprise a rhenium alloy having greater than 0 at.% to 14 at.% of Mo, in order to improved stent properties such as strength, durability, hardness, biostability, bendability, radial strength, flexibility, tensile strength/elongation, radiopacity, biocompatibility, improved fatigue life, etc., as taught by Roth.
Response to Arguments
Applicant's arguments filed 06/08/2026 have been fully considered but they are not persuasive. Applicant argues the rejection of independent claim 17, as currently amended, as being unpatentable over the prior art of Weber, stating that Weber does not specifically disclose the increased surface area, due to the surface structuring/pores, is increased by a factor of 1.1 to 10, compared to an electropolished surface, further stating “The distinguishing feature accelerates and improves control of the dissolution and re-sorption behavior of the stent”, and that the “factor of 1.1-10 defines a controlled increase in the relevant surface-related dissolution behavior. It is therefore not a decorative or arbitrary geometrical modification, but a parameter that is tied to the technical effect of adjusting metallic dissolution”. Examiner respectfully disagrees with Applicant’s assertions. Paragraphs [0024], [0036], and [0041], (of the PG Pub) of the specification of the current application at hand, are the only times in the entire specification is “acceleration of the dissolution and resorption” mentioned and attributed to the surface structuring (it is to be noted that the feature of “improving control” of dissolution/resorption could not be found anywhere in the specification); however, nowhere in any of these paragraphs, is there any mention of the surface area being increasing by a factor of 1.1-10. Thus, one of ordinary skill would be led to believe that the “acceleration of the dissolution and resorption” behavior of the stent is due in general to the surface of the stent/struts having a surface structuring. There was no criticality given anywhere in the originally filed disclosure, of the current application at hand, of the surface area being increased specifically by a factor of 1.1-10; in fact, this range was only mentioned once, in passing, in the entire specification and states the “surface of the struts may have been increased with the surface structuring by a factor of 1.1 to 10 compared to an electropolished surface of the struts” (emphasis added). Thereby, iterating that this parameter, i.e. the increase being by a factor of 1.1 to 10, is a mere matter of normal design choice, not involving a novel, inventive step; and it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate increase in surface area, due to the surface structuring/pores, including by a factor of 1.1 to 10, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05).
Applicant further goes on to state “Weber advantageously discloses that a barrier layer can smooth the outer surface of porous stent struts” and therefore “Weber is rather teaching away from using structure to hasten metallic dissolution than suggesting the claimed surface structuring by a factor of 1.1 to 10 compared to an electropolished surface of the struts”; and further states that “Weber uses pores for controlling drug release, not for defining or controlling an increase in the surface area of the struts for degradation control”. Again, Examiner respectfully disagrees with Applicant’s assertions. It is to be noted that, according to paragraph [0020] of Weber, “FIGS. 5A-5D show examples of cross-sections of stent struts according to different embodiments” (emphasis added). The embodiment used in the rejection of claim 17 is Figure 5A, while the Applicant’s arguments are related to embodiments of Figures 5B-5D. Regarding the embodiment of Figure 5A (as used in the rejections), there are no therapeutic agents/drugs in the surface structuring/pores, or anywhere on the stent, nor is there a barrier coating on/around the surface structuring/stent; these features are related to embodiments of Figures 5B-5D. The embodiment of Figure 5A only has metallic struts (22) with a completely covering coating (82), wherein paragraph [0034] states “FIG. 5A depicts a cross-section of a stent strut 22 with a highly structured porous surface and a conformal coating 82 that coats the inner surfaces of the pores and fully protects the bioerodible magnesium alloy of the stent strut” (emphasis added), and paragraph [0033] explains that “As used herein, “conformal” means that the coating follows the contours of the medical device geometry and continuously covers over substantially all the surfaces of the medical device”. Therefore, Applicant’s above mentioned arguments are considered moot, since only the embodiment of Figure 5A was used in the rejection(s). Thus, the rejection if independent claim 17, as being unpatentable over the prior art of Weber, is deemed to be proper since all the structural limitations set forth in the claim are taught; hence, the rejection stands.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 07/15/2026
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