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 06/16/2023. As directed by the amendment, claims 1-16 have been cancelled and new claims 17-33 have been added. Thus, claims 17-33 are presently pending in this application, and currently examined in the Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the surface structuring is created periodically and/or elevations, using rings and/or peaks (claim 20) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 17 is objected to because of the following informalities: lines 3-4 state “made of a first bioresorbable metallic material, is formed and” (emphasis added); the words “is formed” do not seem to make sense in this context. It is suggested the words “is formed” be deleted. Appropriate correction is required.
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 17-33 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.
Regarding claim 17, which sets forth the parameter of “a completely covering coating…is created on the surface of the struts” (emphasis added), on lines 5-6, however, this parameter is found to be confusing since it is not clear what exactly is meant by the coating being “completely covering”; does this mean the covering completely covers the surface of the stent, and if so which surface, i.e. luminal, abluminal, both, or does it mean the coating encases the strut as a whole, or does it mean something else completely different. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 19, which recites the parameter of “the surface of the struts, which are made of the first bioresorbable metallic material, is increased with a surface structuring by a factor of 1.1 to 10”; however this parameter is found to be confusing for multiple reasons. Firstly, it is unclear how exactly a surface can be increased, i.e. a surface is just a location not a dimension; thus, for the purpose of examination, it shall be interpreted that the surface area is increased by the surface structuring. Secondly, lines 2-3 recites the limitation “a surface structuring”, is this surface structuring the same as the one first recited on line 3 of claim 18, from which claim 19 depends; if not, then it is further confusing as to how many different surface structuring there are and how they related to each other and/or the final structure of the stent, however if they are the same surface structuring as recited in claim 18 (as it seems to be) it is suggested the limitation be amended by deleted the word “a” and replacing it with the word “the” (in order to avoid confusing and keep claim terminology consistent).
Regarding claim 20, which recites the limitation “the surface structuring”, on line 1; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this issue, it is suggested claim 20 depend from claim 18 (which introduces the limitation) instead of depending from claim 17. Furthermore the claim sets forth the parameter of “the surface structuring is created periodically and/or using grooves, troughs or valleys and/or elevations, using rings and/or peaks”; however this parameter is found to be confusing for multiple reasons. Firstly, it is unclear what exactly is meant, structurally, by the surface structuring being “created periodically”; and secondly it is unclear what exactly, structurally, is meant “elevations, using rings and/or peaks”. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claims 22-24 and 26-28, the term/abbreviation “at” is recited before the percentage sign (%) when setting forth different chemicals of an alloy; it is not clear what exactly is meant by the term/abbreviation “at”, is this a typographical error and instead meant to state “wt” (i.e. percent by weight), or does it mean/stand for something else. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 23, which recites the limitation “a molybdenum alloy”, on line 1, is this molybdenum alloy the same as the one first recited on line 2 of claim 22, from which this claim depends. If not, then it is further confusing as to how many different molybdenum alloys there are and how they related to each other and/or the final structure of the stent; however if it is the same molybdenum alloy as recited in claim 22, as it seems to be, then it is suggested the limitation be amended by deleted the word “a” and replacing it with the word “the”, in order to avoid confusing and keep claim terminology consistent.
Regarding claim 24, which recites the limitation “a tungsten alloy”, on line 1, is this tungsten alloy the same as the one first recited on line 3 of claim 22, from which this claim depends. If not, then it is further confusing as to how many different tungsten alloys there are and how they related to each other and/or the final structure of the stent; however if it is the same tungsten alloy as recited in claim 22, as it seems to be, then it is suggested the limitation be amended by deleted the word “a” and replacing it with the word “the”, in order to avoid confusing and keep claim terminology consistent.
Regarding claim 26, which recites the limitation “a rhenium base alloy”, on line 1, is this rhenium base alloy the same as the one first recited on line 2 of claim 25, from which this claim depends. If not, then it is further confusing as to how many different rhenium base alloys there are and how they related to each other and/or the final structure of the stent; however if it is the same rhenium base alloy as recited in claim 25, as it seems to be, then it is suggested the limitation be amended by deleted the word “a” and replacing it with the word “the”, in order to avoid confusing and keep claim terminology consistent.
Regarding claims 27 and 28, both of which depend from claim 26, which sets forth the alloy is a rhenium base alloy; however claims 27 and 28 set forth specific chemical percentages for “a molybdenum base alloy” and “a tungsten base alloy”, respectively; however, this is found to be confusing since it is not clear if the alloy is a rhenium base alloy or a 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 claim indefinite. In order to overcome this rejection, it is suggested both claims 27 and 28 depend from claim 25 instead of claim 26; and it is also suggested that the word “a” before the word molybdenum/tungsten be deleted and replaced with the word “the”, in both claims 27 and 28, in order to keep claim terminology consistent.
Regarding claim 29, which sets forth the parameter of “the second metallic material is pure molybdenum, if the first metallic material is produced with tungsten or with a tungsten base alloy…” (emphasis added); however this parameter is found to be confusing since it is not clear what exactly is actively being claimed. Specifically, the claim does not actively set forth/claim that the first metallic material is/must be tungsten or a tungsten alloy, therefore, what exact structural/chemical limitation is needed to meet the claim if the first metallic material is not tungsten/a tungsten alloy; would just meeting the parameter(s) set forth in claim 17, from which claim 29 depends, be enough to also meet claim 29 in such a scenario. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 30, which recites the limitations “the sum”, on line 1 and “the volume”, on lines 1 and 2; there is insufficient antecedent basis for these limitations in the claim. In order to overcome this rejection, it is suggested the word “the” be deleted and replaced with the word “a” every time the above mentioned limitations are set forth on lines 1 and 2.
Regarding claims 31 and 32, set forth the parameter of the thickness of the coating being in specific ranges and further sets forth “taking into consideration the dissolution rate and the time required for the restoration of the vessel wall”; however this parameter/portion of the parameter is found to be confusing. It is not clear if the above mentioned wording is merely clarifying how the ranges were reached, or if they would actively change the ranges set forth in the claims based on specific dissolution rates and/or time required for restoration, and/or what exactly are these dissolution rates and/or times required for restoration. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite. For the purpose of examination the claims shall be interpreted as “the coating is created with a layer thickness in a range of 1nm to 1000nm” (claim 31) and “the coating is created with a layer thickness in a range of 1nm to 50nm” (claim 32); appropriate correction is suggested.
Regarding claim 33, which recites the limitation of “the layer thickness”, on line 1; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this issue, it is suggested the above mentioned limitation be amended to state either: “a thickness” or “a layer thickness”. Furthermore, the parameter set forth in the claim is found to be confusing, since it is not clear what exactly is meant by the thickness “on the surface of the struts varies”; varies how, along the length of the strut(s), or between different struts, or in different locations or a struct and/or multiple struts. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17, 18, 20, 29 and 30-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weber et al. (US PG Pub. 2012/0059455), hereinafter Weber.
Regarding claims 17 and 29, 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 the surface of the struts (22), 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] & [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. Additionally, since the first metallic material is not tungsten/a tungsten alloy, Weber also reads on claim 29 by meeting all the limitations set forth in claim 17, from which claim 29 depends).
Regarding claims 18 and 20, Weber discloses the stent according to claim 17, 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 which is produced with elevations and depressions/created periodically using troughs or valleys, illustrated in Figure 5A.
Regarding claim 30, Weber discloses the stent according to claim 17, wherein the sum of the 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, taking into consideration the dissolution rate and the time required for the restoration of the vessel wall ([0008], Lines 1-3).
Regarding claim 33, Weber discloses the stent according to claim 17, wherein the layer thickness of the coating on the surface of the struts varies ([0043], Line 1).
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Weber.
Regarding claim 19, Weber discloses the stent according to claim 18, wherein the surface area of the struts (22), which are made of the first bioresorbable metallic material, is increased with the surface structuring/pores compared to an electropolished surface of the struts, illustrated in Figure 5A; and though it is not specifically stated the increase in surface are 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 surface area/increase in surface are due to the surface structuring/pores, including being increased 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 structuring increasing the surface area of the struts by a factor of 1.1 to 10 compared to an electropolished surface, as opposed to being increased by any other factor.
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), 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% tungsten and greater than 0% to 37% rhenium (Re).
However, Jansen teaches a stent, in the same filed of endeavor, comprising a tungsten alloy comprising at least 50% tungsten and greater than 0% to 37% 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% tungsten and greater than 0% to 37% 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).
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% molybdenum (Mo) and greater than 0% to less than 50% tungsten (W), tantalum (Ta) and/or niobium (Nb), and/or and greater than 0% to 42% 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% molybdenum (Mo) and greater than 0% to less than 50% tungsten (W), tantalum (Ta) and/or niobium (Nb), and/or and greater than 0% to 42% 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% Re, while the rest have 0-40% Re; thus the alloy of Ex. 14 comprises at least 5% Re, while the alloy(s) could comprise less Re at 0.001%-4.999%).
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% molybdenum and greater than 0% to less than 50% tungsten (W), tantalum (Ta) and/or niobium (Nb), and/or and greater than 0% to 42% rhenium (Re), and for 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, 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% tungsten (W) and greater than 0% to less than 50% molybdenum (Mo), tantalum (Ta) and/or niobium (Nb), and/or and greater than 0% to 37% rhenium (Re); and the second metallic material is a tungsten (W) alloy having greater than 0% to 37% 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% tungsten (W) and greater than 0% to less than 50% molybdenum (Mo), tantalum (Ta) and/or niobium (Nb), and/or and greater than 0% to 37% rhenium (Re); and the second metallic material is a tungsten (W) alloy having greater than 0% to 37% 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% Re, while the rest have 0-40% Re; thus the alloy of Ex. 28 comprises at least 5% Re, while the alloy(s) could comprise less Re at 0.001%-4.999%).
In view of the teachings of Roth’684, 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% tungsten (W) and greater than 0% to less than 50% molybdenum (Mo), tantalum (Ta) and/or niobium (Nb), and/or and greater than 0% to 37% rhenium (Re); and the second metallic material is a tungsten (W) alloy having greater than 0% to 37% 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% to 14% of Mo or a content of greater than 0% to 20% 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% to 14% 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’684, 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% to 14% 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.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774 02/06/2026