DEATILED 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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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: “wherein said threadlike elements are flat segments cut along a length of a tube”. Specifically, the antecedent basis for “flat segments”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally filled specification lacks support for the newly added amendment “wherein said threadlike elements are flat segments cut along a length of a tube”. Examiner cannot find support for the term flat segments cut along a tube. As shown in the instant application, the cuts are along a cylindrical tube and would not be flat
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.
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.
Claim(s) 1 and 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Culley et al. US 9545323 B2, herein referred to as Culley, in view of Kessler et al. US 8092469 B2, herein referred to as Kessler, and in further view of Khairkhahan et al. US 7192439 B2, herein referred to as Khairkhahan, and yet in further view of Montorfano WO 2019138334 A1 et al., herein referred to as Montorfano.
Regarding claim 1, Culley discloses a device (Figs 2a and 2b, 200) for inserting a guide wire suitable entry into a blood vessel (Col 1, lines 19-30), comprising: an external catheter (210) having a wall defining a longitudinal axis and a circumferential direction (surface of 211), an internal catheter (230/240) inserted into said external catheter (Fig 2a-b), wherein said external catheter defines an anchoring element (Annotated Fig 2a below) adapted to abut the internal walls of the blood vessel (Col 3, lines 63-65), said anchoring element (annotated Fig 2a below) comprising:
- a distal annular portion of said wall of the external catheter (Annotated Fig 2a below), fixed to said internal catheter so as to move integrally with said internal catheter when it is advanced or retracted, (moving from Figs 1a-b to Figs 2a-b; see Col 4, lines 45-65)
- a proximal annular portion of said wall of the external catheter (Annotated Fig 2a below), sliding on said internal catheter, wherein the wall of the external catheter does not have continuity solutions in correspondence with said distal annular portion and with said proximal annular portion (Col 3, lines 63-65),
- a median annular portion of said wall of the external catheter (Annotated Fig 2a below), sliding on said internal catheter (Col 3, lines 63-65), comprising at least a first plurality of notches (spaces between 211) directed according to said longitudinal axis and having a first length (length of 211), in which all said notches divide the wall of the median annular portion of the external catheter and define between them a plurality of threadlike elements (211) suspended above said internal catheter, wherein said threadlike elements are flat segments cut along a length of a tube (along tuber catheter system Figs 2a);
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Annotated Culley Fig 2a
Culley does not explicitly disclose a second plurality of direct notches according to said longitudinal axis and having a second length; wherein said threadlike elements are configured for: - folding away radially with respect to said internal catheter when said handle portion is pulled, causing the internal catheter to retract along said longitudinal axis with respect to the external catheter, abutting against said internal walls of the blood vessel in opposite points, counteracting displacements of the internal catheter transversely to said longitudinal axis, - extending along the longitudinal axis when said handle portion is pushed by advancing the internal catheter along said longitudinal axis with respect to the external catheter; wherein said notches of the first plurality of notches have respective ends longitudinally misaligned along said circumferential direction to respective ends of the notches of the second plurality of notches, so that the notches of the first plurality of notches are offset along the circumferential direction with respect to the notches of the second plurality of notches; and wherein the device [is] for inserting a guide wire suitable for heart valve prostheses into a blood vessel.
Moreover, in the same field of endeavor, Kessler discloses a similar guide catheter (Fig 6, 40’). Kessler teaches [a first plurality of notches] (48’); and a second plurality of direct notches (Fig 6-7, 46’) according to said longitudinal axis and having a second length (Fig 6-70) and; wherein said notches of the first plurality of notches have respective ends longitudinally misaligned along said circumferential direction to respective ends of the notches of the second plurality of notches (Fig 6-7), so that the notches of the first plurality of notches are offset along the circumferential direction with respect to the notches of the second plurality of notches (Fig 6-7).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the anchoring component of Culley to incorporate a second plurality of direct notches according to said longitudinal axis and having a second length, as taught and suggested by Kessler in order to change the basket size of the anchoring component, (Kessler [0022]).
However, in the same field of endeavor, Khairkhahan discloses a similar guide catheter (Fig 6, 40’). Khairkhahan teaches having a handle portion (Fig 17, 309) configured to allow a user to advance or retract said internal catheter (Fig 17, 332) along said longitudinal axis (Col 12, lines 8-14);
wherein said threadlike elements (Fig 7-b, 17) are configured for:
- folding away radially with respect to said internal catheter when said handle portion is pulled (Col 13, lines 38-53), causing the internal catheter to retract along said longitudinal axis with respect to the external catheter (Figs 17a-b; Col 13, lines 38-53), abutting against said internal walls of the blood vessel in opposite points, counteracting displacements of the internal catheter transversely to said longitudinal axis Figs 17a-b; Col 13, lines 38-53,
- extending along the longitudinal axis when said handle portion is pushed by advancing the internal catheter along said longitudinal axis with respect to the external catheter (Figs 17a-b; Col 13, lines 38-53).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the catheter deployment of Culley to incorporate having a handle portion configured to allow a user to advance or retract said internal catheter along said longitudinal axis; wherein said threadlike elements are configured for: - folding away radially with respect to said internal catheter when said handle portion is pulled, causing the internal catheter to retract along said longitudinal axis with respect to the external catheter, abutting against said internal walls of the blood vessel in opposite points, counteracting displacements of the internal catheter transversely to said longitudinal axis - extending along the longitudinal axis when said handle portion is pushed by advancing the internal catheter along said longitudinal axis with respect to the external catheter, as taught and suggested by Khairkhahan in order to provide single-handed operation functionality (Khairkhahan, Col 11, lines 52-60).
However, the combination of Culley, Kessler, and Khairkhahan do not disclose [wherein the] device [is] for inserting a guide wire suitable for heart valve prostheses into a blood vessel.
Additionally, in the same field of endeavor, Montorfano discloses a device (Fig 1a) for inserting a guide wire suitable for heart valve prostheses into a blood vessel (pg 1, lines 1-5).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the device of Culley as modified by Khairkhahan and Kessler to incorporate [wherein the] device for inserting a guide wire suitable for heart valve prostheses into a blood vessel, as suggested and taught by Montorfano in order to guide a valve prosthesis through a blood vessel for implantation (Montorfano Col 3, lines 21-31).
Regarding claim 3, the combination as made of Culley, Kessler, Khairkhahan and Montorfano, specifically Kessler, teaches wherein the notches of said first plurality of notches are orderly alternated with the notches of said second plurality of notches along said circumferential direction of the median portion (expanding component) of the wall of the external catheter (Kessler Figs 6-7), so that each threadlike element of said threadlike elements is defined by a notch of the first plurality of notches and by a notch of the second plurality of notches (Kessler Fig 6-7).
Since Kessler teaches wherein the notches of said first plurality of notches are orderly alternated with the notches of said second plurality of notches along said circumferential direction of the median portion of the wall of the external catheter, so that each threadlike element of said threadlike elements is defined by a notch of the first plurality of notches and by a notch of the second plurality of notches, which would be incorporated in the anchoring element when the modification is made.
Regarding claim 4, Kessler teaches in which the notches of said first plurality of notches have their respective ends aligned with each other along said circumferential direction of the median portion of the wall of the external catheter (Kessler Figs 6-7), and the notches of said second plurality of notches have their respective ends aligned with each other along said circumferential direction of the median portion of the wall of the external catheter (Kessler Figs 6-7).
Since Kessler teaches in which the notches of said first plurality of notches have their respective ends aligned with each other along said circumferential direction of the median portion of the wall of the external catheter, and the notches of said second plurality of notches have their respective ends aligned with each other along said circumferential direction of the median portion of the wall of the external catheter, which would be incorporated in the anchoring element when the modification is made.
Regarding claim 5, the combination as made of Culley, Kessler, Khairkhahan and Montorfano, specifically Kessler teaches comprising a guide wire (Fig 3, 54) for heart valve prostheses inserted in said internal catheter (40; intended use).
Therefore, it would have been obvious to one of ordinary skill in the art prior the effective filling date of the invention to modify the internal catheter of Cully to incorporate comprising a guide wire for heart valve prostheses inserted in said internal catheter, which would be incorporated in the internal catheter when the modification was made, as taught and suggested by Kessler in order to advance the tool to a desire location (Col 5, lines 9-20). Additionally, it would have been obvious to use the guidewire for the intend use of delivering a heart valve prosthesis inserted in said internal catheter as claim, also taught and suggested by Montorfano in order to advance a heart valve prosthesis to a desired implantation site (Montorfano pg 2, line 29- pg 3 line 2).
Regarding claim 6, Cully teaches comprising a preformed guiding catheter (240) slidably inserted in said internal catheter (Cully Col 4, lines 45-65).
Regarding claim 7, Cully teaches in which said threadlike elements are made of biocompatible material (Col 7, line 60- Col 8, lines 7).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Culley in view of Kessler, Khairkhahan and Montorfano, and further in view of Bosma et al. US 6443972-B1, herein referred to as Bosma.
Regarding claim 2, the combination of Culley, Kessler, Khairkhahan and Montorfano does not disclose wherein said second length is equal to said first length.
However, in the same field endeavor, Bosma discloses a similar implant delivery device (Fig 1, 1). Bosma teaches wherein said second length is equal to said first length (Fig 11, 31 length of 20).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the device of Culley as modified by to Khairkhahan, Kessler and Montorfano to incorporate wherein said second length is equal to said first length, as taught and suggested by Bosma in order to improve manufacturing of a tubular element (Bosma [0022]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Culley in view of Kessler, Khairkhahan and Montorfano, and further in view of Bulman et al. US 20180207395 A1, herein referred to as Bulman.
Regarding claim 8, the combination of Culley, Kessler, Khairkhahan and Montorfano does not disclose further comprising a hemostatic valve fixed to said external catheter, configured so that said internal catheter slides tightly therethrough along said longitudinal axis.
However, in the same field of endeavor, Bulman teaches a similar device (Fig 1, guide catheter 214). Bulman teaches further comprising a hemostatic valve fixed to said external catheter [0052], configured so that said internal catheter (Fig 1, 218 nose catheter) slides tightly therethrough along said longitudinal axis (so that the catheter forms a seal in the device, prevent unnecessary bleeding [0052]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the device of Culley as modified by to Khairkhahan, Kessler and Montorfano to incorporate teaches further comprising a hemostatic valve fixed to said external catheter, as taught and suggested by Bulman in order to form a seal in the device (Bulman [0052]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
Matthew DeSanto
/MATTHEW F DESANTO/Primary Examiner, Art Unit 3700
