DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
3. The abstract of the disclosure is objected to because the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length (the current Abstract exceeds 150 words). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
4. Claim 30 is objected to because of the following informalities:
a. Regarding claim 30, please substitute:
“wherein the meshwork has 52 wires each with a wire diameter of 0.042 mm and having a tolerance of ±0.2 mm, and
wherein the meshwork has an outside diameter of one of 5.17 mm, 5.67 mm,or 6.17 mm”
with:
--wherein the meshwork has 52 wires each with a wire diameter of 0.042 mm and having a tolerance of [[±0.2]] ±0.003 mm, and
wherein the meshwork has an outside diameter of one of 5.17 mm, 5.67 mm, or 6.17 mm--
See [0014] of the PG Pub of the instant application. Appropriate correction is required.
Drawings
5. The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
a. Therefore, the “wherein the meshwork has a cylindrical section and a conical section, and wherein the conical section forms the first stent end” (claim 17) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
b. Therefore, the “and has an angle of twist different from that of the cylindrical section” (claim 17) 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 Rejections - 35 USC § 112
6. 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.
7. Claims 15-34 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.
a. Regarding independent claim 15, the recitation “wherein the meshwork has an outside diameter of one of 3.65 mm, 4.15 mm, or 4.65 mm” (lines 10-11) renders claim 15 indefinite as to the scope of the invention. Is said “an outside diameter” in a collapsed state/configuration? Or, is said “an outside diameter” in an expanded (when implanted) state/configuration? Claims 16-29 depend from claim 15.
b. Regarding independent claim 30, the recitation “wherein the meshwork has an outside diameter of one of 5.17 mm, 5.67 mm, or 6.17 mm” (lines 10-11) renders claim 15 indefinite as to the scope of the invention. Is said “an outside diameter” in a collapsed state/configuration? Or, is said “an outside diameter” in an expanded (when implanted) state/configuration? Claims 31 and 32 depend from claim 30.
c. Regarding independent claim 33, the recitation “wherein the meshwork has an outside diameter of one of 7.18 mm or 8.20 mm” (lines 10-11) renders claim 15 indefinite as to the scope of the invention. Is said “an outside diameter” in a collapsed state/configuration? Or, is said “an outside diameter” in an expanded (when implanted) state/configuration? Claim 34 depends from claim 33.
d. Regarding claim 17, the recitation “and has an angle of twist different from that of the cylindrical section” (line 3) is vague and unclear, rendering claim 17 indefinite as to the scope of the invention. Claims 18, 19, and 20 depend from claim 17.
(i) The point of reference (for the purpose of discerning each of the an “angle of twist”) has not been recited in the claim language.
(ii) Further, is the “an angle of twist” referring to an angle of “twist” of the particular section as a whole (i.e., the conical section as a whole), or is it referring to an angle of “twist” of the wires of the particular section (i.e., twist or braid or spiral angle of the wires of the, e.g., conical section)? This is NOT clear from the specification.
(iii) Additionally, are the angles of twist when the stent is in a collapsed state/configuration? Or, are the angles of twist when the stent is in an expanded (when implanted) state/configuration?
e. Regarding claim 31, the recitation “and has an angle of twist different from that of the cylindrical section” (line 3) is vague and unclear, rendering claim 31 indefinite as to the scope of the invention. Claim 32 depend from claim 31.
(i) The point of reference (for the purpose of discerning each of the an “angle of twist”) has not been recited in the claim language.
(ii) Further, is the “an angle of twist” referring to an angle of “twist” of the particular section as a whole (i.e., the conical section as a whole), or is it referring to an angle of “twist” of the wires of the particular section (i.e., twist or braid or spiral angle of the wires of the, e.g., conical section)? This is NOT clear from the specification.
(iii) Additionally, are the angles of twist when the stent is in a collapsed state/configuration? Or, are the angles of twist when the stent is in an expanded (when implanted) state/configuration?
f. Regarding claim 34, the recitation “and has an angle of twist different from that of the cylindrical section” (line 3) is vague and unclear, rendering claim 34 indefinite as to the scope of the invention.
(i) The point of reference (for the purpose of discerning each of the an “angle of twist”) has not been recited in the claim language.
(ii) Further, is the “an angle of twist” referring to an angle of “twist” of the particular section as a whole (i.e., the conical section as a whole), or is it referring to an angle of “twist” of the wires of the particular section (i.e., twist or braid or spiral angle of the wires of the, e.g., conical section)? This is NOT clear from the specification.
(iii) Additionally, are the angles of twist when the stent is in a collapsed state/configuration? Or, are the angles of twist when the stent is in an expanded (when implanted) state/configuration?
Claim Rejections - 35 USC § 103
8. 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.
9. Claims 15-26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Cattaneo (DE 10 2015 107 291; cited in Applicant’s IDS).
Regarding independent claim 15, Cattaneo ‘291 discloses (Figures 3-5) a stent comprising:
a meshwork (1) of wires (2) having a radiopaque core material (Abstract; [0001]; [0006]) and a superelastic sheath material (Abstract; [0001]; [0006]), the wires configured and arranged to form loops at a first stent end (Figures 3-5; paragraphs [0004] and [0006]) and open wire ends at a second stent end (Figures 3-5; paragraph [0006]), wherein a number of the open wire ends is twice the number of the loops (when looking at the plane of each of Figures 3-5, a number of the open wire ends is clearly shown as twice the number of the loops in the same plane, and therefore a number of the open wire ends is twice the number of the loops), and more than 10 % by volume of each wire is formed by the radiopaque core material ([0014] – 15.1%; [0010] – 15.6%), and
wherein the meshwork has 48 wires each ([0006]).
Paragraph [0006] of Cattaneo ‘291 discloses a wire diameter of 0.040 mm.
Paragraph [0008] of Cattaneo ‘291 discloses a wire diameter of 0.030 mm to 0.045 mm (therefore, Cattaneo ‘291 discloses a wire diameter is 0.038 mm - as recited in claim 15).
Paragraph [0006] of Cattaneo ‘291 discloses the meshwork as having an outside diameter of 3.50 mm, or 5.0 mm, or 5.5 mm, or 6.0 mm.
Paragraph [0006] of Cattaneo ‘291 discloses the meshwork as having a length of, e.g., 15 mm, 40 mm, or 50 mm.
The subject matter of claim 15 thus differs from the stent of Cattaneo ‘291 in that the meshwork has an outside diameter of one of 3.65 mm, 4.15 mm, or 4.65 mm. The subject matter of claim 15 consists of selecting marginally different diameters of wire and stent from the same range as already described in Cattaneo ‘291. However, such a selection can only be considered inventive if these differences in diameter have unexpected effects or properties compared to the rest of the range. However, such effects or properties are not specified in the application (as originally filed).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have modified the stent of Cattaneo ‘291 wherein the meshwork has an outside diameter of one of 3.65 mm, 4.15 mm, or 4.65 mm, 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. In re Aller, 105 USPQ 233. Further, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 16, Cattaneo ‘291 does not specifically teach wherein the outside diameter has a tolerance of ±0.2 mm. However, the stent of Cattaneo ‘291 appears to be identical or substantially identical to the claimed invention absent a showing of unobvious differences. Accordingly, it would be expected that the stent of Cattaneo ‘291 would have the instantly claimed tolerance. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established” and “[a] chemical composition and its properties are inseparable”.
Cattaneo ‘291 teaches a stent having the same structural components of the stent as the instant application, and as such a skilled artisan would reasonably expect the same components to yield the same properties (e.g., tolerance) as that of the claimed implant.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 17, Cattaneo ‘291 teaches wherein the meshwork has a cylindrical section and a conical section (Figures 3-5), and wherein the conical section forms the first stent end and has an angle of twist (Cattaneo ‘291 refers to it as “braid angle”) different from that of the cylindrical section ([0006]).
Regarding claim 18, Cattaneo ‘291 teaches wherein a first angle of twist in the cylindrical section is 75° and a second angle of twist in the conical section is 60° (Figures 3-5, and paragraph [0006]).
Regarding claim 19, Cattaneo ‘291 does not specifically teach wherein the first angle of twist has a tolerance of ±2° and the second angle of twist has a tolerance of ±4°. However, the stent of Cattaneo ‘291 appears to be identical or substantially identical to the claimed invention absent a showing of unobvious differences. Accordingly, it would be expected that the stent of Cattaneo ‘291 would have the instantly claimed tolerance. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established” and “[a] chemical composition and its properties are inseparable”.
Cattaneo ‘291 teaches a stent having the same structural components of the stent as the instant application, and as such a skilled artisan would reasonably expect the same components to yield the same properties (e.g., tolerance) as that of the claimed implant.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 20, Cattaneo ‘291 teaches wherein a transitional section having a smaller angle of twist and a higher porosity than the cylindrical section is provided between the cylindrical section and the conical section (Figures 3-5, and paragraph [0006]).
Regarding claim 21, Cattaneo ‘291 teaches wherein a length of the meshwork is between 12 mm and 38 mm (paragraph [0006] of Cattaneo ‘291 discloses the meshwork as having a length of, e.g., 15 mm). 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. In re Aller, 105 USPQ 233. Further, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 22, Cattaneo ‘291 does not specifically teach wherein the length has a tolerance of ±1 mm. However, the stent of Cattaneo ‘291 appears to be identical or substantially identical to the claimed invention absent a showing of unobvious differences. Accordingly, it would be expected that the stent of Cattaneo ‘291 would have the instantly claimed tolerance. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established” and “[a] chemical composition and its properties are inseparable”.
Cattaneo ‘291 teaches a stent having the same structural components of the stent as the instant application, and as such a skilled artisan would reasonably expect the same components to yield the same properties (e.g., tolerance) as that of the claimed implant.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 23, Cattaneo ‘291 teaches wherein a length of the meshwork is one of 12 mm, 13 mm, 15 mm, 16 mm, 19 mm, 20 mm, 22 mm, 23 mm, 24 mm, 28 mm, 30 mm, 31 mm, 37 mm, or 38 mm (paragraph [0006] of Cattaneo ‘291 discloses the meshwork as having a length of, e.g., 15 mm). 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. In re Aller, 105 USPQ 233. Further, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 24, Cattaneo ‘291 does not specifically teach wherein the length has a tolerance of ±1 mm. However, the stent of Cattaneo ‘291 appears to be identical or substantially identical to the claimed invention absent a showing of unobvious differences. Accordingly, it would be expected that the stent of Cattaneo ‘291 would have the instantly claimed tolerance. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established” and “[a] chemical composition and its properties are inseparable”.
Cattaneo ‘291 teaches a stent having the same structural components of the stent as the instant application, and as such a skilled artisan would reasonably expect the same components to yield the same properties (e.g., tolerance) as that of the claimed implant.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 25, Cattaneo ‘291 teaches wherein the first stent end has a length of 4 mm (Cattaneo ‘291 discloses the meshwork as having a length of, e.g., 15 mm, 40 mm, or 50 mm; the recited “a length” of the first stent end can be arbitrarily chosen to be “a length of 4 mm”).
Regarding claim 26, Cattaneo ‘291 does not specifically teach wherein the length has a tolerance of ±1 mm. However, the stent of Cattaneo ‘291 appears to be identical or substantially identical to the claimed invention absent a showing of unobvious differences. Accordingly, it would be expected that the stent of Cattaneo ‘291 would have the instantly claimed tolerance. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established” and “[a] chemical composition and its properties are inseparable”.
Cattaneo ‘291 teaches a stent having the same structural components of the stent as the instant application, and as such a skilled artisan would reasonably expect the same components to yield the same properties (e.g., tolerance) as that of the claimed implant.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 29, Figures 3 and 4 of Cattaneo ‘291 clearly show wherein the meshwork has no additional radiographic markers and consists exclusively of the wires.
10. Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Cattaneo (DE 10 2015 107 291; cited in Applicant’s IDS) in view of Meissner (DE 20 2015 102 114 U1)
Regarding claim 27, Cattaneo ‘291 discloses the invention as claimed, except for particularly disclosing wherein the meshwork has a shimmering blue oxide surface. However, this is already known in the art. For example, Meissner ‘114 teaches (Figure 1) a stent comprising a meshwork (10) having a shimmering blue oxide surface (Abstract; [0005]; [0007]; [0022]) in order to increase layer hardness, and therefore the wear of the stent is reduced in the vessel ([0007]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the meshwork has a shimmering blue oxide surface, as taught by Meissner ‘114, with the invention of Cattaneo ‘291, in order to increase layer hardness, and therefore the wear of the stent is reduced in the vessel.
Regarding claim 28, Cattaneo ‘291 in view of Meissner ‘114 teaches wherein the oxide surface is formed by a mixed oxide layer of titanium oxynitride (Meissner ‘114 - Abstract; [0005]; [0007]; [0022]). Regarding the layer thickness of between 150 nm and 400 nm, 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. In re Aller, 105 USPQ 233. Further, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
11. Claims 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Cattaneo (DE 10 2015 107 291; cited in Applicant’s IDS) in view of Berez et al. (US PG Pub No. 2018/0280169 A1).
Regarding independent claim 30, Cattaneo ‘291 discloses (Figures 3-5) a stent comprising:
a meshwork (1) of wires (2) having a radiopaque core material (Abstract; [0001]; [0006]) and a superelastic sheath material (Abstract; [0001]; [0006]), the wires configured and arranged to form loops at a first stent end (Figures 3-5; paragraphs [0004] and [0006]) and open wire ends at a second stent end (Figures 3-5; paragraph [0006]), wherein a number of the open wire ends is twice the number of the loops (when looking at the plane of each of Figures 3-5, a number of the open wire ends is clearly shown as twice the number of the loops in the same plane, and therefore a number of the open wire ends is twice the number of the loops), and more than 10 % by volume of each wire is formed by the radiopaque core material ([0014] – 15.1%; [0010] – 15.6%), and
wherein the meshwork has 48 wires each ([0006]).
Paragraph [0006] of Cattaneo ‘291 discloses a wire diameter of 0.040 mm.
Paragraph [0008] of Cattaneo ‘291 discloses a wire diameter of 0.030 mm to 0.045 mm (therefore, Cattaneo ‘291 discloses a wire diameter is 0.042 mm - as recited in claim 30).
Paragraph [0006] of Cattaneo ‘291 discloses the meshwork as having an outside diameter of 3.50 mm, or 5.0 mm, or 5.5 mm, or 6.0 mm.
Paragraph [0006] of Cattaneo ‘291 discloses the meshwork as having a length of, e.g., 15 mm, 40 mm, or 50 mm.
The subject matter of claim 30 thus differs from the stent of Cattaneo ‘291 in that wherein the meshwork has 52 wires, and wherein the meshwork has an outside diameter of one of 5.17 mm, 5.67 mm, or 6.17 mm. The subject matter of claim 30 consists of selecting marginally different diameters of wire and stent from the same range as already described in Cattaneo ‘291. However, such a selection can only be considered inventive if these differences in diameter have unexpected effects or properties compared to the rest of the range. However, such effects or properties are not specified in the application (as originally filed).
Further, this is already known in the art. For example, Berez et al. ‘169 teaches stent embodiments, each comprising a meshwork of wires. Paragraph [0148] of Berez et al. ‘169 states - “In some embodiments, the diameter of the strands of the stent ranges from about 0.001 inch to about 0.0014 inch. In some embodiments, the number of strands selected for a stent is based on the desired diameter of the stent. For example, in some embodiments, 48 strands are used for a stent diameter ranging from about 2.75 mm to about 4.25 mm, 64 strands are used for a stent diameter ranging from about 4.5 mm to about 6.0 mm, 72 strands are used for a stent diameter ranging from 6.0 mm and greater, and 32 strands are used for a stent diameter ranging from 2.5 mm and smaller”.
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the meshwork has 52 wires, and wherein the meshwork has an outside diameter of one of 5.17 mm, 5.67 mm, or 6.17 mm, as taught by Berez et al. ‘169, with the invention of Cattaneo ‘291, since it is already well-known in the art to select for a stent the number of wires, and wire diameter, based on the desired diameter of the stent and its intended purpose. Also, 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. In re Aller, 105 USPQ 233. Further, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
Regarding “and having a tolerance of ±0.2 mm”, the stent of Cattaneo ‘291 appears to be identical or substantially identical to the claimed invention absent a showing of unobvious differences. Accordingly, it would be expected that the stent of Cattaneo ‘291 would have the instantly claimed tolerance. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established” and “[a] chemical composition and its properties are inseparable”.
Cattaneo ‘291 teaches a stent having the same structural components of the stent as the instant application, and as such a skilled artisan would reasonably expect the same components to yield the same properties (e.g., tolerance) as that of the claimed implant.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 31, Cattaneo ‘291 teaches wherein the meshwork has a cylindrical section and a conical section (Figures 3-5), and wherein the conical section forms the first stent end and has an angle of twist (Cattaneo ‘291 refers to it as “braid angle”) different from that of the cylindrical section ([0006]).
Regarding claim 32, Cattaneo ‘291 teaches wherein a transitional section having a smaller angle of twist and a higher porosity than the cylindrical section is provided between the cylindrical section and the conical section (Figures 3-5, and paragraph [0006]).
12. Claims 33 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Cattaneo (DE 10 2015 107 291; cited in Applicant’s IDS) in view of Berez et al. (US PG Pub No. 2018/0280169 A1).
Regarding independent claim 33, Cattaneo ‘291 discloses (Figures 3-5) a stent comprising:
a meshwork (1) of wires (2) having a radiopaque core material (Abstract; [0001]; [0006]) and a superelastic sheath material (Abstract; [0001]; [0006]), the wires configured and arranged to form loops at a first stent end (Figures 3-5; paragraphs [0004] and [0006]) and open wire ends at a second stent end (Figures 3-5; paragraph [0006]), wherein a number of the open wire ends is twice the number of the loops (when looking at the plane of each of Figures 3-5, a number of the open wire ends is clearly shown as twice the number of the loops in the same plane, and therefore a number of the open wire ends is twice the number of the loops), and more than 10 % by volume of each wire is formed by the radiopaque core material ([0014] – 15.1%; [0010] – 15.6%), and
wherein the meshwork has 48 wires each ([0006]).
Paragraph [0006] of Cattaneo ‘291 discloses a wire diameter of 0.040 mm.
Paragraph [0008] of Cattaneo ‘291 discloses a wire diameter of 0.030 mm to 0.045 mm.
Paragraph [0006] of Cattaneo ‘291 discloses the meshwork as having an outside diameter of 3.50 mm, or 5.0 mm, or 5.5 mm, or 6.0 mm.
Paragraph [0006] of Cattaneo ‘291 discloses the meshwork as having a length of, e.g., 15 mm, 40 mm, or 50 mm.
The subject matter of claim 33 thus differs from the stent of Cattaneo ‘291 in that wherein the meshwork has 64 wires each with a wire diameter of one of 0.046 mm or 0.05 mm, and wherein the meshwork has an outside diameter of one of 7.18 mm or 8.20 mm. The subject matter of claim 33 consists of selecting marginally different diameters of wire and stent from the same range as already described in Cattaneo ‘291. However, such a selection can only be considered inventive if these differences in diameter have unexpected effects or properties compared to the rest of the range. However, such effects or properties are not specified in the application (as originally filed).
Further, this is already known in the art. For example, Berez et al. ‘169 teaches stent embodiments, each comprising a meshwork of wires. Paragraph [0148] of Berez et al. ‘169 states - “In some embodiments, the diameter of the strands of the stent ranges from about 0.001 inch to about 0.0014 inch. In some embodiments, the number of strands selected for a stent is based on the desired diameter of the stent. For example, in some embodiments, 48 strands are used for a stent diameter ranging from about 2.75 mm to about 4.25 mm, 64 strands are used for a stent diameter ranging from about 4.5 mm to about 6.0 mm, 72 strands are used for a stent diameter ranging from 6.0 mm and greater, and 32 strands are used for a stent diameter ranging from 2.5 mm and smaller”.
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the meshwork has 64 wires each with a wire diameter of one of 0.046 mm or 0.05 mm, and wherein the meshwork has an outside diameter of one of 7.18 mm or 8.20 mm, as taught by Berez et al. ‘169, with the invention of Cattaneo ‘291, since it is already well-known in the art to select for a stent the number of wires, and wire diameter, based on the desired diameter of the stent and its intended purpose. Also, 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. In re Aller, 105 USPQ 233. Further, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 34, Cattaneo ‘291 teaches wherein the meshwork has a cylindrical section and a conical section (Figures 3-5), and wherein the conical section forms the first stent end and has an angle of twist (Cattaneo ‘291 refers to it as “braid angle”) different from that of the cylindrical section ([0006]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774