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 .
Claim Objections
Claims 2-4, 7-8, 10, and 19-20 are objected to because of the following informalities:
Claim 2, line 1, “rings” should read “ring”.
Claim 3, line 1, “rings” should read “ring”.
Claim 3, line 3, “rings” should read “ring”.
Claim 4, line 3, “rings” should read “ring”.
Claim 7, line 2, “jackets” should read “jacket”.
Claim 8, line 2, “one or more” should be inserted before “polymer distal jackets”.
Claim 10, line 2, “rings” should read “ring”.
Claim 10, line 3, “rings” should read “ring”.
Claim 10, line 4, both occurrences “rings” should read “ring”.
Claim 10, line 6, “rings” should read “ring”.
Claim 10, line 7, both occurrences “rings” should read “ring”.
Claim 19, line 10, “rings” should read “ring”.
Claim 19, line 11, “rings” should read “ring”.
Claim 19, line 12, both occurrences “rings” should read “ring”.
Claim 19, line 13, “rings” should read “ring”.
Claim 19, line 14, both occurrences “rings” should read “ring”.
Claim 20, line 5, “rings” should read “ring”.
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 1-20 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.
Claim 1 recites the limitation "the distal end of the expansible portion" in line 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the distal end of the expansible portion" in line 6-7. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the distal end of the inner line" in line 1. There is insufficient antecedent basis for this limitation in the claim.
The limitation of claim 19, line 12 of “a distal end of the expansile portion” is indefinite because it is unclear if this limitation is the same as or different than the previously recited “distal end of the expansile portion” (claim 19).
The limitation of claim 20, line 5 of “a first circumferential rings of cells” is indefinite because it is unclear if this limitation is the same as or different than the previously recited “first circumferential rings of cells (claim 19).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0137418 (Kelly) in view of US 2023/02930295 (Neumann).
1. A catheter (catheter 100) comprising:
a proximal elongate shaft (elongate shaft ) comprising a distal end, a lumen (lumen 116), and a first plurality of wire braided segments (proximal braid 120)(FIG. 3-4; P0072);
a distal tip section (distal tip section 210) connected to the distal end of the proximal elongate shaft (FIG. 3; P0057), the distal tip section comprising (i) a proximal tubular body (tubular proximal portion 211), (ii) an expansile portion (distal expansile portion 213) having a collapsed delivery configuration and an expanded deployed configuration (FIG. 2; P0061), and (iii) a second plurality of wire braided segments (braided section 220) comprising circumferential rings of cells, the distal end of the expansile portion comprising distal hoops where wires of the second plurality of wire braided segments invert to loop back through the second plurality of wire braided segments and create distalmost cells of the expansile portion (FIG. 3; P0066 and P0082);
one or more polymer body jackets (body jackets 160) disposed around the proximal elongate shaft (FIG. 4; P0077) and one or more polymer distal jackets (tip jackets 180) disposed around the distal tip section (FIG. 7; P0059-P0060, P0079, and P0095); and
one or more radiopaque pucks (marker bands 118, 121)(FIG. 9G and 9I; P0069-P0070 and P0088).
Kelly discloses the invention substantially as claimed as discussed above but does not disclose the one or more puck being positioned within one or more of the distalmost cells. Neumann teaches a catheter in the same field of endeavor having radiopaque pucks (marks 729) positioned within one or more of the distalmost cells (FIG. 57; P0211) for the purpose of preventing the markers/pucks from interfering with the expansion of the braid (FIG. 57; P0211).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the markers/pucks of Kelly to be positioned within one or more of the distalmost cells as taught by Neumann in order to prevent the markers/pucks from interfering with the expansion of the braid.
2-4. At least two radiopaque pucks positioned within a first circumferential rings of cells defined by the distalmost cells (FIG. 57; P0211). At least four radiopaque pucks positioned within a first circumferential rings of cells defined by the distalmost cells, the four radiopaque pucks evenly positioned around the first circumferential rings of cells (FIG. 57; P0211). A first radiopaque puck of the one or more radiopaque pucks is positioned in one of the distalmost cells, and wherein the catheter comprises a second radiopaque puck positioned in a first circumferential rings of cells proximal to the distalmost cells (FIG. 57; P0211).
9. The expansile portion comprises between 6 and 8 circumferential rings of cells between the proximal tubular body and the distal end of the expansile portion (FIG. 2; P0084).
10. The catheter of claim 1, wherein:
the expansile portion comprises at least a first circumferential rings of cells proximate a transition between the proximal tubular body and the expansile portion, a second circumferential rings of cells adjacent and distal to the first circumferential rings of cells, and a third circumferential rings of cells proximate a distal end of the expansile portion (FIG. 2 and 6; P0084 and P0093);
the first circumferential rings of cells comprises closed cells having a first braid angle, the second circumferential rings of cells comprises closed cells having a second braid angle, and the third circumferential rings of cells comprises closed cells having a third braid angle (FIG. 6; P0022-P0023 and P0093).
Kelly discloses the invention substantially as claimed as discussed above and further discloses the braid angle being a result effective variable in that braid angle is inversely related to expansion capability (P0093) but does not explicitly recite the first braid angle is approximately 65°, and the third braid angle is approximately 53°. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the first braid angle to approximately 65°, and the third braid angle to be approximately 53° as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, a person having ordinary skill in the art would have a reasonable expectation of success in modifying the braid angles of Kelly to be the specified angles.
11. The one or more polymer body jackets and the one or more polymer distal jackets transition from a harder material to a softer material (P0064), wherein a hardness of a most proximal polymer body jacket is approximately 72 Shore D in hardness (P0030), and wherein a hardness of a distalmost end profile jacket is approximately 42 Shore A in hardness (P0030).
12. The proximal elongate shaft comprises stainless steel (P0026 and P0075), and the distal tip section comprises at least one of (i) tungsten, (ii) Nitinol, or (iii) a composite of Nitinol with a tantalum or platinum core (P0026 and P0080).
Claim(s) 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0137418 (Kelly) in view of US 2023/02930295 (Neumann), as applied to claim 1 above, and further in view of US 2024/0100297 (Tran).
Kelly discloses the invention substantially as claimed as discussed above and further discloses the catheter comprising an inner liner (inner liner 115) positioned internally to the first plurality of wire braided segments and the second plurality of wire braided segments (FIG. 3; P0063 and P0073). However, Kelly does not disclose the inner liner comprising at least one longitudinal slit at its distal end to enable expansion of the expansile portion into the expanded deployed configuration. Tran teaches a catheter in the same field of endeavor having an inner liner (inner liner 4408) with at least one longitudinal slit (slit 4412) at its distal end to enable expansion of the expansile portion into the expanded deployed state (FIG. 45; P0416) for the purpose of promoting expansion of the expansile portion (FIG. 45; P0416-P0417).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the inner liner of Kelly to include at least one longitudinal slit as taught by Tran in order to promote expansion of the expansile portion.
6. The catheter comprising at least two longitudinal slits at the distal end of the inner liner (Tran: P0450).
7. The one or more radiopaque pucks are positioned between a polymer distal jacket and the inner liner (Neumann: P0211).
8. The one or more radiopaque pucks are positioned between an inner layer and an outer layer of the polymer distal jackets (Neumann: P0211).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0137418 (Kelly).
19. A catheter (catheter 100) comprising:
a proximal elongate shaft (elongate shaft ) comprising a distal end, a lumen (lumen 116), and a first plurality of wire braided segments (proximal braid 120)(FIG. 3-4; P0072);
a distal tip section (distal tip section 210) connected to the distal end of the proximal elongate shaft (FIG. 3; P0057), the distal tip section comprising (i) a proximal tubular body (tubular proximal portion 211), (ii) an expansile portion (distal expansile portion 213) having a collapsed delivery configuration and an expanded deployed configuration (FIG. 2; P0061), and (iii) a second plurality of wire braided segments (braided section 220) comprising circumferential rings of cells (FIG. 3; P0066 and P0082);
one or more polymer body jackets (body jackets 160) disposed around the proximal elongate shaft (FIG. 4; P0077) and one or more polymer distal jackets (tip jackets 180) disposed around the distal tip section (FIG. 7; P0059-P0060, P0079, and P0095); and
where a distal end of the expansile portion comprising distal hoops where wires of the second plurality of wire braided segments invert to loop back through the second plurality of wire braided segments (FIG. 3; P0066 and P0082);
where the expansile portion comprises at least a first circumferential rings of cells proximate a transition between the proximal tubular body and the expansile portion, a second circumferential rings of cells adjacent and distal to the first circumferential rings of cells, and a third circumferential rings of cells proximate a distal end of the expansile portion (FIG. 2 and 6; P0084 and P0093);
the first circumferential rings of cells comprises closed cells having a first braid angle, the second circumferential rings of cells comprises closed cells having a second braid angle, and the third circumferential rings of cells comprises closed cells having a third braid angle (FIG. 6; P0022-P0023 and P0093).
Kelly discloses the invention substantially as claimed as discussed above and discloses the first braid angle is greater than or equal to the second braid angle (FIG. 6; P0093) and further discloses the braid angle being a result effective variable in that braid angle is inversely related to expansion capability (P0093) but does not explicitly recite the first braid angle is approximately 65°, and the third braid angle is approximately 53°. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the first braid angle to approximately 65°, and the third braid angle to be approximately 53° as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, a person having ordinary skill in the art would have a reasonable expectation of success in modifying the braid angles of Kelly to be the specified angles.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0137418 (Kelly), as applied to claim 19 above, and further in view of US 2023/02930295 (Neumann).
20. Kelly discloses the invention substantially as claimed as discussed above and further discloses the distal end of the expansile portion comprising distal hoops where wires of the second plurality of wire braided segments invert to loop back through the second plurality of wire braided segments and create distalmost cells of the expansile portion (FIG. 3; P0066 and P0082); and where the catheter has radiopaque pucks (marker bands 118, 121)(FIG. 9G and 9I; P0069-P0070 and P0088). However, Kelly does not disclose the pucks being positioned within the first circumferential ring of cells defined by the distalmost cells. Neumann teaches a catheter in the same field of endeavor having radiopaque pucks (marks 729) positioned within the first circumferential ring of cells defined by the distalmost cells (FIG. 57; P0211) for the purpose of preventing the markers/pucks from interfering with the expansion of the braid (FIG. 57; P0211). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the markers/pucks of Kelly to be positioned within one or more of the distalmost cells as taught by Neumann in order to prevent the markers/pucks from interfering with the expansion of the braid.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
Prosecution Insights