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.
Response to Amendment
3. Applicant’s cancellation of claims 1-14 in the reply filed on 17 May 2023 is acknowledged.
4. Applicant’s addition of claims 15-29 in the reply filed on 17 May 2023 is acknowledged.
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 a distal end of the introducer has a connector for connection to a catheter” (claim 23) 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. Claim 28 is 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 claim 28, the recitation “wherein the stent has no additional radiographic markers” (lines 1-2) renders the claim indefinite as to the scope of the invention. The recitation “wherein the stent has no additional radiographic markers” suggests there are radiographic marker(s) recited in claim 15. The stent, as described in claim 15, does not recite any radiographic marker(s).
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 15-25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Vong et al. (US PG Pub No. 2017/0172766 A1) in view of Meissner (DE 10 2012 112 730 A1; cited in Applicant’s IDS).
Regarding independent claim 15, Vong et al. ‘766 discloses a medical kit for treatment of one or more diseases of a blood vessel comprising:
a tubular introducer (Figure 8 – introducer 133; Figures 54 and 55 – introducer 782);
a transport wire (Figure 8 – wire 130; Figures 54 and 55 – wire 794; Figure 51 – wire 772) having a distal tip (Figure 8 – tip 144; Figures 54 and 55 – distal end of wire 794); and
a stent (Figures 1 and 8 – stent 100; Figure 54 – stent 793) including a meshwork of multiple wires (102) configured and arranged to form loops (Figure 1 – loops 104; Figure 54 – loops abutting surface 792D) at a proximal stent end (Figure 1 and paragraphs [0052], [0054], and [0055] – wires 102; Figure 54 and paragraph [0144]), wherein the stent is disposed on the transport wire (Figures 8 and 54) and further disposed inside the tubular introducer (Figures 8 and 54), and wherein the distal stent end is positioned closer to the distal tip of the transport wire than the proximal stent end (see, at least, Figure 8).
Vong et al. ‘766 discloses the invention as claimed, except for particularly disclosing open wire ends at a distal stent end. Notice, paragraph [0032] of the PG Pub of the instant application recites “Preferably, loops are present at the proximal stent end only. In this preferred variation of the invention, the wires form open wire ends at the distal stent end”. In other words, there is no criticality in the use of “open wire ends at the distal stent end” since the end of the stent with open wire ends is presented as a preferred variation/embodiment.
Further, this is already known in the art. For example, Meissner ‘730 teaches (Figure 1) a stent (10) with loops (22) at one stent end (12) and open wire ends (24) at an opposite stent end (11), wherein the open wire ends provide reduced radial force at that stent end ([0032], [0034]). Notice, paragraph [0035] of Meissner ‘730 discloses an embodiment wherein both stent ends may have loops. 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 open wire ends at a distal stent end, as taught by Meissner ‘730, with the invention of Vong et al. ‘766, in order to provide reduce radial force at that stent end.
As noted by the United States Supreme Court, if a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. KSR, 127 S. Ct. at 1740. "When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82USPQ2d 1385, 1396 (2007).
Regarding claim 16, Vong et al. ‘766 teaches wherein the proximal stent end is disposed between a proximal radiographic marker (Figure 8 – marker 136) and a distal radiographic marker (Figure 8 – marker 140) of the transport wire ([0070], [0071]).
Regarding claim 17, Vong et al. ‘766 teaches wherein the transport wire (Figure 8 – wire 130; Figures 54 and 55 – wire 794) has a transport section (Figure 8 – section 138; Figure 54 – section of 794 located inside stent 793) and a guide section (Figure 8 – section including 136/134; Figure 54 – section including member 792 and proximal part of 794) having a diameter larger than a diameter of the transport section (Figure 8 – 136 has a diameter larger than a diameter of 138; Figure 54 - 792 has a diameter larger than a diameter of section of 794 located inside stent 793), and wherein the guide section has an abutment surface (Figure 8 – distal surface of 136; Figure 54 – surface 792D of 792) on which the loops of the proximal stent end bear in an axial direction.
Regarding claim 18, Figure 8 of Vong et al. ‘766 clearly shows wherein the proximal radiographic marker (136) of the transport wire is disposed at a distal end of the guide section.
Regarding claim 19, Figure 8 of Vong et al. ‘766 clearly shows wherein the proximal radiographic marker directly borders the abutment surface and forms the abutment surface (i.e., marker 136 comprises an “abutment surface”).
Regarding claim 20, Vong et al. ‘766 teaches wherein the transport section (Figure 8 – section 138; Figure 54 – section of 794 located inside stent 793) of the transport wire extends completely through the stent.
Regarding claim 21, Figure 8 of Vong et al. ‘766 clearly shows wherein the distal radiographic marker (140) of the transport wire is disposed in the transport section.
Regarding claim 22, Figure 51 of Vong et al. ‘766 clearly shows wherein the transport wire protrudes proximally out of the introducer and has a proximal gripping section with ribbing (778).
Regarding claim 23, Vong et al. ‘766 teaches wherein a distal end of the introducer has a connector (Figure 8 – distal end of 133 is capable of connecting to a catheter; Figure 51 – distal section of introducer is shown as connected to catheter 774) for connection to a catheter (the “a catheter” is NOT positively claimed).
Regarding claim 24, Vong et al. ‘766 in view of Meissner ‘730 teaches wherein the loops comprise first loops and second loops disposed at the proximal stent end, and wherein the first loops protrude beyond the second loops in an axial direction (Figure 54 of Vong et al. ‘766 clearly shows alternating first long loops and second short loops; Figure 1 and paragraphs [0032] and [0034] of Meissner ‘730 teaches alternating first long loops 22 and second short loops 22).
Regarding claim 25, Vong et al. ‘766 in view of Meissner ‘730 teaches wherein a same number of the first loops and the second loops are provided at the proximal stent end, and wherein the first loops and the second loops are disposed in alternation in a circumferential direction (Meissner ‘730 - Figure 1 and paragraphs [0032] and [0034]). Notice, looking at the specification of the instant application, there is no criticality in the use of “a same number of the first loops and the second loops are provided at the proximal stent end” and “wherein the first loops and the second loops are disposed in alternation in a circumferential direction”. A person having ordinary skill in the art will be left with the choice of the same or different number of first loops and second loops provided at proximal stent end, and the choice of alternation between first loops and second loops in a circumferential direction, depending on the particular condition of a patient (i.e., patient dependent).
Regarding claim 28, as best understood, Vong et al. ‘766 teaches wherein the stent has no additional radiographic markers and exclusively consists of the multiple wires (no radiographic markers are recited in claim 15, and the stent of Vong et al. ‘766 consists of the multiple wires).
10. Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Vong et al. (US PG Pub No. 2017/0172766 A1) in view of Meissner (DE 10 2012 112 730 A1; cited in Applicant’s IDS) as applied to claim 15 above, and further in view of Ding (US PG Pub No. 2017/0128242 A1).
Regarding claim 26, Vong et al. ‘766 in view of Meissner ‘730 teaches wherein the wires of the meshwork have a core including a radiopaque material and a sheath including a shape memory material (Meissner ‘730 discloses filaments 21 as “equipped with a core wire, which consists of a radiopaque material”; “at least one filament of the trellis tube may comprise a core wire of a radiopaque material”; “It is particularly preferred if at least one-sixth, in particular at least a quarter, in particular at least half of the filaments which form the support braid and / or the compaction braid, comprise a core wire made of a radiopaque material” – [0016]; Meissner ‘730 further discloses filaments 21 as “The filaments may also comprise or consist of a superelastic metal, in particular nitinol”; “the filaments 21 of the support braid 20 be formed by wires of nitinol” – [0015], [0016]).
Further, this is already known in the art. For example, Ding ‘242 teaches (Figure 1) a stent (3) with end loops 4 ([0016], [0019]) at a stent end, open wire ends ([0011]) at opposite stent end, and wires (1) having a core including a radiopaque material ([0008] - tantalum; platinum-iridium, which are radiopaque materials) and a sheath including a shape memory material ([0004] and claim 7). 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 wires of the meshwork have a core including a radiopaque material and a sheath including a shape memory material, as taught by Ding ‘242, with the invention of Vong et al. ‘766 in view of Meissner ‘730, 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 as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 27, Vong et al. ‘766 in view of Meissner ‘730, as modified by Ding ‘242, teaches wherein at least 10 % by volume of each wire of the meshwork is formed by the core (Ding ‘242 - [0008], [0009]).
11. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Vong et al. (US PG Pub No. 2017/0172766 A1) in view of Meissner (DE 10 2012 112 730 A1; cited in Applicant’s IDS).
Regarding independent claim 29, Vong et al. ‘766 discloses a medical kit for treatment of one or more diseases of a blood vessel comprising:
a tubular introducer (Figure 8 – introducer 133; Figures 54 and 55 – introducer 782);
a transport wire (Figure 8 – wire 130; Figures 54 and 55 – wire 794; Figure 51 – wire 772) having a distal tip (Figure 8 – tip 144; Figures 54 and 55 – distal end of wire 794); and
a stent (Figures 1 and 8 – stent 100; Figure 54 – stent 793) including a meshwork of multiple wires (102) configured and arranged to form loops (Figure 1 – loops 104; Figure 54 – loops abutting surface 792D) at a proximal stent end (Figure 1 and paragraphs [0052], [0054], and [0055] – wires 102; Figure 54 and paragraph [0144]), wherein the stent is disposed on the transport wire (Figures 8 and 54) and further disposed inside the tubular introducer (Figures 8 and 54), and wherein the distal stent end is positioned closer to the distal tip of the transport wire than the proximal stent end (see, at least, Figure 8),
wherein the transport wire (Figure 8 – wire 130; Figures 54 and 55 – wire 794) has a transport section (Figure 8 – section 138; Figure 54 – section of 794 located inside stent 793) and a guide section (Figure 8 – section including 136/134; Figure 54 – section including member 792 and proximal part of 794) having a diameter larger than a diameter of the transport section (Figure 8 – 136 has a diameter larger than a diameter of 138; Figure 54 - 792 has a diameter larger than a diameter of section of 794 located inside stent 793),
wherein the guide section has an abutment surface (Figure 8 – distal surface of 136; Figure 54 – surface 792D of 792) on which the loops of the proximal stent end bear in an axial direction.
Vong et al. ‘766 discloses the invention as claimed, except for particularly disclosing open wire ends at a distal stent end. Notice, paragraph [0032] of the PG Pub of the instant application recites “Preferably, loops are present at the proximal stent end only. In this preferred variation of the invention, the wires form open wire ends at the distal stent end”. In other words, there is no criticality in the use of “open wire ends at the distal stent end” since the end of the stent with open wire ends is presented as a preferred variation/embodiment.
Further, this is already known in the art. For example, Meissner ‘730 teaches (Figure 1) a stent (10) with loops (22) at one stent end (12) and open wire ends (24) at an opposite stent end (11), wherein the open wire ends provide reduced radial force at that stent end ([0032], [0034]). Notice, paragraph [0035] of Meissner ‘730 discloses an embodiment wherein both stent ends may have loops. 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 open wire ends at a distal stent end, as taught by Meissner ‘730, with the invention of Vong et al. ‘766, in order to provide reduce radial force at that stent end.
As noted by the United States Supreme Court, if a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. KSR, 127 S. Ct. at 1740. "When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82USPQ2d 1385, 1396 (2007).
Regarding last wherein clause of independent claim 29, wherein the loops comprise first loops and second loops disposed at the proximal stent end, and wherein the first loops protrude beyond the second loops in an axial direction (Figure 54 of Vong et al. ‘766 clearly shows alternating first long loops and second short loops; Figure 1 and paragraphs [0032] and [0034] of Meissner ‘730 teaches alternating first long loops 22 and second short loops 22).
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).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774