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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The limitation in lines 10-11 of the claim 1, “a middle non-tapered section with a longitudinally open semi-circular shape and a proximal end that tapers downwardly in the proximal direction” was not described or found in the specification filed on 6/29/2022. see 203 of Fig. 9a and ¶0053 of the current application that show that “a middle non-tapered section with a longitudinally open semi-circular shape”. Note: the examiner will interpret that the limitation such as a middle non-tapered section with a longitudinally open semi-circular shape and a proximal end that tapers inwardly and downwardly
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, 3-11 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 recites the limitation “a middle non-tapered section with a longitudinally open semi-circular shape and a proximal end that tapers downwardly in the proximal direction” in lines 10-11. It is unclear if it means “a middle non-tapered section with a longitudinal opening with a semi-circular shape and a proximal end that tapers inwardly and downwardly” see Fig. 9a-11d or it means “a middle non-tapered section with a longitudinally open semi-circular shape inwardly downwardly along the proximal direction” see Fig. 9a-11d. Note: for the purpose of examination, the examiner will interpret the limitation such as “a middle non-tapered section with a longitudinal opening with a semi-circular shape and a proximal end that tapers inwardly and downwardly”.
Claim 5 recites the limitation “ the flat ribbon section does not reduce an inner diameter of the flexible tube” in lines 1-2. It is unclear if it means that “the flat ribbon section does not block an inner diameter of the flexible tube” or it means “the flat ribbon section does not require for a taper an inner diameter of the flexible tube”. Note, the examiner will interpret the limitation such as “the flat ribbon section does not block an inner diameter of the flexible tube”.
Claim 6 recites the limitation “ the flat ribbon section does not reduce an inner diameter of the flexible tube” in lines 1-2. It is unclear if it means that “the flat ribbon section does not block an inner diameter of the flexible tube” or it means “the flat ribbon section does not require for a taper an inner diameter of the flexible tube”. Note, the examiner will interpret the limitation such as “the flat ribbon section does not block an inner diameter of the flexible tube”.
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(s) 1, 3-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Di Caprio et al. (US. 20140276618A1)(“Di Caprio”) in view of Cottone (US. 20160121080A1).
Re claim 1, Di Caprio discloses a guide extension catheter (Fig. 1-21b, ¶0092) comprising: a flexible tube section (such as section 20 of 14, ¶0088) having a flexible, reinforced portion (mesh, ¶0088) comprising one or more of the group consisting of: a laser-cut tube a braid and at least two oppositely wound coils (braided mesh, ¶0088), wherein the flexible tube section has a polymer that defines a wall (¶0088), a proximal reinforcing section (section included 58a-b, 144, Fig. 21a-b) disposed proximal to the flexible, reinforced portion and disposed within the wall of the flexible tube section (Fig. 21a, ¶0101), the proximal reinforcing section comprising: a skived distal section that tapers downwardly in the proximal direction (58a-b, Fig. 21a), a middle non-tapered section (from lower portion of 58a-b to 144); a semi-circular section formed by the polymer defining the wall of the flexible tube section (section above 144 to left end of 40, Fig. 21a) and disposed proximal to the proximal reinforcing section (Fig. 21a) and comprising a flattened bottom section (bottom section of 40 is flat); a flat ribbon section (section between 16 and 40, Fig. 3a) connected with a proximal portion of the proximal reinforcing section portion (40) and extending proximally along the flattened bottom section of the semi- circular section (Fig. 21a); and a push rod (16) operatively connected with a proximal portion of the flat ribbon section, (Fig. 21a) the push rod comprising a proximal handle (32), and wherein the proximal reinforcing section (58a-b, 144) does not extend proximally beyond a proximal end of the semi-circular section, but it fails to disclose that the flexible tube section is coated with a polymer that defines a wall and the middle non-tapered section with a longitudinally open semi-circular shape and a proximal end that tapers downwardly in the proximal direction.
However, Cottone discloses a guide extension catheter (abstract, ¶0009, Fig. 15a-d) and wherein the flexible tube section (¶0104) is coated with a polymer that defines a wall (filled with polymer, ¶0073 to form the wall 1800) and the middle non-tapered section (1820 section) with a longitudinally open semi-circular shape (1825) and a proximal end that tapers downwardly in the proximal direction (1825, Fig. 15d).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify catheter of Di Caprio so that the flexible tube section is coated with a polymer that defines a wall and the middle non-tapered section with a longitudinally open semi-circular shape and a proximal end that tapers downwardly in the proximal direction as taught by Cottone for the purpose of improving the flexibility and allowing for entire structure to be maneuvered through a tortuous path or anatomy (Cottone, ¶0104).
Re claim 3, Di Caprio discloses wherein the proximal reinforcing section comprises a flat or curvilinear bottom connector section( section at 144) and wherein the flat ribbon section is connected to the flat or curvilinear bottom connector section (Fig. 21a).
Re claim 4, Di Caprio fails to disclose wherein a proximal end of flat or curvilinear bottom connector section defines a cutout that is complementary in shape with a shape of a distal end of the flat ribbon section, whereby the flat ribbon section is operatively connected within the cutout and thereby connected with the proximal reinforcing section.
However, Cottone discloses a guide extension catheter (abstract, ¶0009, Fig. 15a-d) and wherein a proximal end of flat (1825)or curvilinear bottom connector section defines a cutout (cutout in 1825) that is complementary in shape with a shape of a distal end of the flat ribbon section (1830), whereby the flat ribbon section is operatively connected within the cutout and thereby connected with the proximal reinforcing section (Fig, 15d).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify catheter of Di Caprio so that a proximal end of flat or curvilinear bottom connector section defines a cutout that is complementary in shape with a shape of a distal end of the flat ribbon section, whereby the flat ribbon section is operatively connected within the cutout and thereby connected with the proximal reinforcing section as taught by Cottone for the purpose of improving the flexibility and allowing for entire structure to be maneuvered through a tortuous path or anatomy (Cottone, ¶0102).
Re claim 5, Di Caprio discloses wherein the connected the flat ribbon section does not reduce an inner diameter of the flexible tube section (Di Caprio, Fig. 3a).
Re claim 6, Di Caprio discloses wherein the connected flat ribbon section does reduce an inner diameter of the flexible tube section (Di Caprio, Fig. 3a).
Re claim 7, the embodiment of Fig. 21 of Di Caprio fails to disclose wherein the semi-circular section comprises a partial cone-shaped flared shape.
However, the embodiment of Fig. 20c of Di Caprio discloses wherein the semi-circular section (44) comprises a partial cone-shaped flared shape ( closed to 130).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify catheter of embodiment of Fig, 21 of Di Caprio so that the semi-circular section comprises a partial cone-shaped flared shape as taught by the embodiment of Fig. 20c of Di Caprio for the purpose of facilitating movement of tools and medical devices along the axis of the boosting guide catheter (Di Caprio, ¶0122).
Re claim 8, Di Caprio discloses wherein the semi-circular section comprises a partial cylinder shape ( Fig. 1).
Re claim 9, Di Caprio fails to disclose wherein the laser-cut tube comprises spiral cuts, wherein the flexible tube section comprises a central longitudinal axis, wherein the spiral cuts comprise a pitch and an angle relative to the central axis, and wherein the pitch and angle are constant moving from a distal to a proximal direction along the laser-cut tube.
However, Cottone discloses a guide extension catheter (abstract, ¶0009, Fig. 15a-d) and wherein the laser-cut tube comprises spiral cuts (close to 1810, spiral cut, ¶0105), wherein the flexible tube section comprises a central longitudinal axis (axis of 1810), wherein the spiral cuts comprise a pitch and an angle relative to the central axis (Fig. 15d), and wherein the pitch and angle are constant moving from a distal to a proximal direction along the laser-cut tube (Fig, 15d, Note, the cut can be in any machinery such as laser ¶0097).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify catheter of Di Caprio so that the laser-cut tube comprises spiral cuts, wherein the flexible tube section comprises a central longitudinal axis, wherein the spiral cuts comprise a pitch and an angle relative to the central axis, and wherein the pitch and angle are constant moving from a distal to a proximal direction along the laser-cut tube as taught by Cottone for the purpose of having specific cut pattern to improve the flexibility of the tube (Cottone, ¶0104).
Re claim 10, Di Caprio fails to disclose wherein the laser-cut tube comprises spiral cuts, wherein the flexible tube section comprises a central longitudinal axis, wherein the spiral cuts comprise a pitch and an angle relative to the central axis, and wherein the pitch and angle are not constant moving from a distal to a proximal direction along the laser-cut tube.
However, Cottone discloses a guide extension catheter (abstract, ¶0009, Fig. 15a-d) and wherein the laser-cut tube comprises spiral cuts (close to 1810, spiral cut, ¶0105), wherein the flexible tube section comprises a central longitudinal axis (axis of 1810), and wherein the pitch and angle are not constant moving from a distal to a proximal direction along the laser-cut tube (Fig. 15d, ¶0104, the width can be vary and not repetitive pattern), and wherein the pitch and angle are constant moving from a distal to a proximal direction along the laser-cut tube (¶0104, the width can be vary and not repetitive pattern, Fig, 15d, Note, the cut can be in any machinery such as laser ¶0097).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify catheter of Di Caprio so that the laser-cut tube comprises spiral cuts, wherein the flexible tube section comprises a central longitudinal axis, wherein the spiral cuts comprise a pitch and an angle relative to the central axis, and wherein the pitch and angle are not constant moving from a distal to a proximal direction along the laser-cut tube as taught by Cottone for the purpose of having specific cut pattern to improve the flexibility of the tube (Cottone, ¶0104).
Re claim 11, Di Caprio fails to disclose wherein the pitch of the spiral cuts becomes longer moving from a distal to a proximal direction along the laser-cut tube.
However, Cottone discloses a guide extension catheter (abstract, ¶0009, Fig. 15a-d) and wherein the laser-cut tube comprises spiral cuts (close to 1810, spiral cut, ¶0105), wherein the flexible tube section comprises a central longitudinal axis (axis of 1810), and wherein the pitch and angle are not constant moving from a distal to a proximal direction along the laser-cut tube (Fig. 15d, ¶0104, the width can be vary and not repetitive pattern), and the pitch of the spiral cuts becomes longer moving from a distal to a proximal direction along the laser-cut tube (¶0100, Fig, 15d, Note, the cut can be in any machinery such as laser ¶0097).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify catheter of Di Caprio so that the pitch of the spiral cuts becomes longer moving from a distal to a proximal direction along the laser-cut tube as taught by Cottone for the purpose of having specific cut pattern to improve the flexibility of the tube (Cottone, ¶0104).
Re claim 12, Di Caprio discloses a guide extension catheter (Fig. 1-21b, ¶0092) comprising: a flexible tube section (such as section 20 of 14, ¶0088) having a flexible, reinforced portion (mesh, ¶0088) comprising one or more of the group consisting of: a laser-cut tube, a braid and at least two oppositely wound coils (braided mesh, ¶0088), wherein the flexible tube section has a polymer that defines a wall (¶0088); a proximal reinforcing section disposed proximal to the flexible, reinforced portion (section included 58a-b, 144, Fig. 21a-b) and comprising: a skived distal section that tapers downwardly in the proximal direction (58a-b, Fig. 21a), a middle non-tapered section (from lower portion of 58a-b to 144) with a longitudinally open semi-circular shape (Fig.21b), a flat or curvilinear bottom connector section (section 144), wherein the proximal reinforcing section is disposed within the wall of the flexible tube section ( Fig. 21a); a semi-circular section formed by the polymer defining the wall of the flexible tube section and disposed proximal to the proximal reinforcing section (section above 144) and comprising a flattened bottom section (lower section of 40), and a flat ribbon section (connection between 40 and 38, Fig. 3a) extending along the flattened bottom section of the semi- circular section (Fig. 3a); and a push rod (16) operatively connected with a proximal portion of the flat ribbon section (Fig. 3a), the push rod comprising a proximal handle (32, Fig. 3a), and wherein the proximal reinforcing section does not extend proximally beyond a proximal end of the semi-circular section (Fig. 21a), but it fails to discloses that the flexible tube section is coated with a polymer that defines a wall and a flat or curvilinear bottom connector section with a proximal end that defines a cutout, a semi-circular support ring connected with the flat or curvilinear bottom connector section at a proximal end of the proximal reinforcing section, and wherein the flat ribbon section is operatively connected within the cutout defined by the flat or curvilinear bottom section.
However, Cottone discloses a guide extension catheter (abstract, ¶0009, Fig. 14a-d) and wherein the flexible tube section (¶0104) is coated with a polymer that defines a wall (filled with polymer, ¶0073 to form the wall 1700) and a flat or curvilinear bottom connector section (section 1730) with a proximal end that defines a cutout (lower section of 1730), a semi-circular support ring connected with the flat or curvilinear bottom connector section (1735) at a proximal end of the proximal reinforcing section (Fig. 14a-c), and wherein the flat ribbon section is operatively connected within the cutout defined by the flat or curvilinear bottom section (section of 1740 that inserted in 1731, see Fig 14c similar to Fig. 15c).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify catheter of Di Caprio so that the flexible tube section is coated with a polymer that defines a wall and a flat or curvilinear bottom connector section with a proximal end that defines a cutout, a semi-circular support ring connected with the flat or curvilinear bottom connector section at a proximal end of the proximal reinforcing section, and wherein the flat ribbon section is operatively connected within the cutout defined by the flat or curvilinear bottom section as taught by Cottone for the purpose of improving the flexibility and allowing for entire structure to be maneuvered through a tortuous path or anatomy (Cottone, ¶0102).
Re claim 13, the embodiment of Fig. 21 of Di Caprio fails to disclose wherein the proximal semi-circular section comprises a partial cone-shaped, flared shape.
However, the embodiment of Fig. 20c of Di Caprio discloses wherein the semi-circular section (44) comprises a partial cone-shaped flared shape ( closed to 130).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify catheter of embodiment of Fig, 21 of Di Caprio so that proximal semi-circular section comprises a partial cone-shaped, flared shape as taught by the embodiment of Fig. 20c of Di Caprio for the purpose of facilitating movement of tools and medical devices along the axis of the boosting guide catheter (Di Caprio, ¶0122).
Re claim 14, Di Caprio discloses wherein the proximal semi-circular section comprises a partial cylinder shape (Fig. 1).
Re claim 15, Di Caprio fails to disclose wherein the semi-circular support ring comprises an expansion member and further comprising an expansible portion, wherein the expansible portion is configured to achieve an undeformed unexpanded configuration and configured to expand to a larger deformed configuration when subjected to a radially outward force.
However, Cottone discloses a guide extension catheter (abstract, ¶0009, Fig. 14a-d) and the semi-circular support ring (1720) comprises an expansion member (1731 and or 1733) and further comprising an expansible portion (outer end of 1731), wherein the expansible portion is configured to achieve an undeformed unexpanded configuration and configured to expand to a larger deformed configuration when subjected to a radially outward force (¶0102, ¶0103, it will expand as it is flexible and or the tube can be made from shape memory material ¶0073).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify catheter of Di Caprio so that the semi-circular support ring comprises an expansion member and further comprising an expansible portion, wherein the expansible portion is configured to achieve an undeformed unexpanded configuration and configured to expand to a larger deformed configuration when subjected to a radially outward force as taught by Cottone for the purpose of improving the flexibility and allowing for entire structure to be maneuvered through a tortuous path or anatomy (Cottone, ¶0102).
Re claim 16, the modified Di Caprio discloses wherein the expansible portion is biased to retain the undeformed configuration (Cottone, ¶0102).
Re claim 17, the modified Di Caprio discloses wherein the expansible portion comprises a shape memory material (Cottone ¶0073).
Re claim 18, the modified Di Caprio discloses wherein the expansion member comprises a z-shape in the undeformed configuration (Cottone is z-shape see 1731 and or 1733).
Re claim 19, Di Caprio discloses a guide extension catheter (Fig. 1-21b, ¶0092) comprising: a flexible tube section (such as section 20 of 14, ¶0088) having a flexible, reinforced portion (mesh, ¶0088) comprising one or more of the group consisting of: a laser-cut tube a braid and at least two oppositely wound coils (braided mesh, ¶0088), wherein the flexible tube section has a polymer that defines a wall (¶0088), a proximal reinforcing section (section included 58a-b, 144, Fig. 21a-b) disposed proximal to the proximal flexible tube portion (Fig. 21a, ¶0101) and comprising: a skived distal section that tapers downwardly in the proximal direction ( section include 58a-b), a middle non-tapered section with a longitudinally open semi-circular shape (section above 144), a flat or curvilinear bottom connector section (144), wherein the proximal reinforcing section is disposed within the wall of the flexible tube section (Fig, 21a); a flat ribbon section (section that connected 16 t8, Fig. 3a) connected with a proximal portion of the flexible, reinforced portion of the flexible tube section (Fig, 21a); and a push rod (16) operatively connected with a proximal portion of the flat ribbon section (Fig. 21a), the push rod comprising a proximal handle (32, Fig. 3a), wherein the proximal reinforcing section does not extend proximally beyond a proximal end (Fig. 3a, 21a), but it fails to discloses that flexible section is coated with a polymer that define a wall, and the flat or curvilinear bottom connector section with a proximal end that defines a cutout, and a complete cone-shaped flared section formed by the polymer that defines the wall of the flexible tube section and disposed proximal to the proximal reinforcing section, the complete cone-shaped flared section comprising longitudinal cross sections that are completely circular so that the proximal reinforcing section does not extend proximally beyond a proximal end of the complete cone-shaped flared section.
However, the embodiment of Fig. 20c of Di Caprio discloses wherein a complete cone-shaped flared section (flared130, Fig. 20c) formed by the polymer that defines the wall of the flexible tube section (¶0122) and disposed proximal to the proximal reinforcing section (Fig. 20c), the complete cone-shaped flared section comprising longitudinal cross sections that are completely circular so that the proximal reinforcing section does not extend proximally beyond a proximal end of the complete cone-shaped flared section (Fig. 20c).
The modified Di Caprio fails to disclose that flexible section is coated with a polymer that define a wall, and the flat or curvilinear bottom connector section with a proximal end that defines a cutout.
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify catheter of embodiment of Fig, 21 of Di Caprio so that a complete cone-shaped flared section formed by the polymer that defines the wall of the flexible tube section and disposed proximal to the proximal reinforcing section, the complete cone-shaped flared section comprising longitudinal cross sections that are completely circular so that the proximal reinforcing section does not extend proximally beyond a proximal end of the complete cone-shaped flared section as taught by the embodiment of Fig. 20c of Di Caprio for the purpose of facilitating movement of tools and medical devices along the axis of the boosting guide catheter (Di Caprio, ¶0122).
However, Cottone discloses a guide extension catheter (abstract, ¶0009, Fig. 14a-d) and wherein the flexible tube section (¶0104) is coated with a polymer that defines a wall (filled with polymer, ¶0073 to form the wall 1700) and a flat or curvilinear bottom connector section (section 1730) with a proximal end that defines a cutout (lower section of 1730), a semi-circular support ring connected with the flat or curvilinear bottom connector section (1735) at a proximal end of the proximal reinforcing section (Fig. 14a-c), and wherein the flat ribbon section is operatively connected within the cutout defined by the flat or curvilinear bottom section (section of 1740 that inserted in 1731, see Fig 14c similar to Fig. 15c).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify catheter of Di Caprio so that that flexible section is coated with a polymer that define a wall, and the flat or curvilinear bottom connector section with a proximal end that defines a cutout as taught by Cottone for the purpose of improving the flexibility and allowing for entire structure to be maneuvered through a tortuous path or anatomy (Cottone, ¶0102).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783