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 . Claims 1, 3, 5, 8-12, 14-20, 22-23, & 25-27 are pending and examined below.
Response to Arguments
Applicant’s arguments, see pages 9-12, filed 04/24/2025, with respect to the rejection(s) of claim(s) 1, 3, 5, 8-12, 14-20, 22-23, & 25-27 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Stinson. Please see the rejection below.
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, 5, 8-12, 14-20, 22-23, and 25-27 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 "a self-expanding tube" in line 5. It is unclear, if this is the same or different “self-expanding tube” from line 1. For the purpose of examination, they are regarded as the same tube.
Claim 12 recites the limitation "a self-expanding tube" in line 5. It is unclear, if this is the same or different “self-expanding tube” from line 1. For the purpose of examination, they are regarded as the same tube.
Claim 20 recites the limitation "a self-expanding tube" in line 5. It is unclear, if this is the same or different “self-expanding tube” from line 1. For the purpose of examination, they are regarded as the same tube.
Claim 26 recites the limitation "the self-expanding tube is configured to self expand from a radially contracted state to a radially expanded state " in lines 2-3. It is unclear, and therefore indefinite, if Applicant is trying to claim the process of the self-expanding tube of self expanding (as this is a method claim as determined by the preamble) OR if Applicant is merely claiming the capability of the self-expanding tube to self-expand (as written in the aforementioned claim requirement).
The dependent claims 3, 5, 8-11, 14-19, 22-23, & 25-27 are likewise rejected.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5, 8-12, 14-19, & 25-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stinson (US 20020099435 A1).
Regarding claim 1, Stinson teaches a delivery system (11, Fig. 2) for deploying a self-expanding tube (31, Fig. 2, ¶0055) into a blood vessel (body lumen, ¶0063), comprising:
a tubular member (51, Fig. 2) configured for insertion into the blood vessel (body lumen, ¶0063);
an elongate body (13, Fig. 2) extending within a lumen of the tubular member (51, Fig. 2); and
a self-expanding tube (31, Fig. 2) positioned radially between the tubular member (51, Fig. 2) and the elongate body (13, Fig. 2), the self-expanding tube (31, Fig. 9) configured to self expand from a radially contracted state (Fig. 2) to a radially expanded state (Fig. 9) in a process involving longitudinal shortening of the self- expanding tube relative to a longitudinal axis of the tubular member (51, Fig. 9, ¶0063), wherein
the delivery system is configured to operate in a deployment mode in which a first longitudinal engagement force (Fig. 9) acting between the self-expanding tube (31, Fig. 9) and the tubular member (51, Fig. 9) and a second longitudinal engagement force acting between the self-expanding tube (31, Fig. 9) and the elongate body (13, Fig. 9) are such that: there is substantially no relative movement longitudinally between the elongate body (13, Fig. 9) and any portion of the self-expanding tube (31, Fig. 9) that remains in engagement with the elongate body during deployment of the self-expanding tube in use (¶0063), deployment of the self-expanding tube comprising longitudinal movement towards a proximal end of the delivery system of the tubular member relative to the elongate body (¶0063);
there is relative movement longitudinally between the elongate body (13, Fig. 9) and a portion of the self-expanding tube (31, Fig. 9) that remains in engagement with the elongate body during retraction of the elongate body in use after at least a portion of the self-expanding tube has been deployed (¶0063), retraction of the elongate body comprising longitudinal movement towards a proximal end of the delivery system of the elongate body relative to the tubular member (¶0063); wherein
the first longitudinal engagement force is larger (Fig. 9), with respect to opposing retraction of the self-expanding tube (31, Fig. 9) relative to the tubular member (51, Fig. 9), after a portion of the self-expanding tube has been deployed out of the tubular member than when none of the self- expanding tube has been deployed out of the tubular member; wherein the maximum obtainable first longitudinal engagement force after a portion of the self-expanding tube has been deployed out of the tubular member, with respect to opposing retraction of the self-expanding tube relative to the tubular member, is larger than the maximum obtainable second longitudinal engagement force (¶0063), wherein
the maximum obtainable first longitudinal engagement force is a static friction force (friction-fit, ¶0060) acting between the self-expanding tube (31, Fig. 9) and the tubular member (51, Fig. 9) and the maximum obtainable second longitudinal engagement force is a static friction force (frictional fit, ¶0054) acting between the self-expanding tube (31, Fig. 9) and the elongate body (13, Fig. 9).
With respect to claim 1, applicant claims: “a first longitudinal engagement force acting between the self-expanding tube and the tubular member and a second longitudinal engagement force acting between the self-expanding tube and the elongate body are such that: there is substantially no relative movement longitudinally between the elongate body and any portion of the self-expanding tube that remains in engagement with the elongate body during deployment of the self-expanding tube in use, deployment of the self-expanding tube comprising longitudinal movement towards a proximal end of the delivery system of the tubular member relative to the elongate body; there is relative movement longitudinally between the elongate body and a portion of the self-expanding tube that remains in engagement with the elongate body during retraction of the elongate body in use after at least a portion of the self-expanding tube has been deployed, retraction of the elongate body comprising longitudinal movement towards a proximal end of the delivery system of the elongate body relative to the tubular member; wherein the first longitudinal engagement force is larger, with respect to opposing retraction of the self-expanding tube relative to the tubular member, after a portion of the self-expanding tube has been deployed out of the tubular member than when none of the self- expanding tube has been deployed out of the tubular member; wherein the maximum obtainable first longitudinal engagement force after a portion of the self-expanding tube has been deployed out of the tubular member, with respect to opposing retraction of the self-expanding tube relative to the tubular member, is larger than the maximum obtainable second longitudinal engagement force,” this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. In this case, the Stinson device discloses all the claimed structural features and is considered to be capable of performing the functions of claim 1 (Figs. 2, 8, & 9).
Regarding claim 3, Stinson teaches
wherein the larger first longitudinal engagement force is achieved by engagement of a radially expanded and longitudinally contracted portion of the self-expanding tube (31, Fig. 9) with a distal end of the tubular member (51, Fig. 9). In this case, the Stinson device discloses all the claimed structural features and is considered to be capable of performing the functions of claim 3 (Figs. 2 & 9).
Regarding claim 5, Stinson teaches
configured such that the maximum obtainable first longitudinal engagement force, with respect to opposing deployment of the self-expanding tube (31, Fig. 9) relative to the tubular member (51, Fig. 9), is smaller than the maximum obtainable second longitudinal engagement force. In this case, the Stinson device discloses all the claimed structural features and is considered to be capable of performing the functions of claim 5 (Figs. 2 & 9).
Regarding claim 8, Stinson teaches
wherein over at least 50% of the length of the self-expanding tube, at least a portion of the self-expanding tube (31, Fig. 9) engages outwardly with the tubular member (51, Fig. 9) and inwardly with the elongate body (13, Fig. 9).
Regarding claim 9, Stinson teaches
configured such that either or both of a composition and surface texture of the inner surface of the tubular member is uniform over a length in which the tubular member (51, Fig. 8) is in contact with the self-expanding tube (31, Fig. 8, ¶0060).
Regarding claim 10, Stinson teaches
configured such that either or both of a composition and surface texture of the outer surface of the elongate body (13, Fig. 9) is uniform over a length in which the elongate body is in contact with the self-expanding tube (31, Fig. 9).
Regarding claim 11, Stinson teaches
further comprising a retaining member (21, Fig. 8) configured to selectively apply a retaining force longitudinally to a proximal region of the self-expanding tube (31, Fig. 8), the delivery system further configured to operate in a retraction mode in which the application of the retaining force allows relative movement longitudinally between the elongate body and a portion of the self-expanding tube that remains in engagement with the elongate body during longitudinal movement of the self-expanding tube in a proximal direction relative to the elongate body (Fig. 8, ¶0060 & 0063). In this case, the Stinson device discloses all the claimed structural features and is considered to be capable of performing the functions of claim 11 (Figs. 2, 8, & 9).
Regarding claim 12, Stinson teaches a delivery system (11, Fig. 2) for deploying a self-expanding tube (31, Fig. 2, ¶0055) into a blood vessel (body lumen, ¶0063), comprising:
a tubular member (51, Fig. 2) configured for insertion into the blood vessel (body lumen, ¶0063);
an elongate body (13, Fig. 2) extending within a lumen of the tubular member (51, Fig. 2);
a self-expanding tube (31, Fig. 2) positioned radially between the tubular member (51, Fig. 2) and the elongate body (13, Fig. 2); and
a retaining member (21, Fig. 8) configured to selectively apply a retaining force longitudinally to a proximal region of the self-expanding tube (Fig. 8, ¶0060), wherein
the delivery system is configured to operate in a retraction mode in which the application of the retaining force allows relative movement longitudinally between the elongate body (13, Fig. 8) and a portion of the self-expanding tube (31, Fig. 8) that remains in engagement with the elongate body during longitudinal movement of the self-expanding tube in a proximal direction relative to the elongate body (¶0063); and
the application of the retaining force is such that there is substantially no relative movement longitudinally between the elongate body (13, Fig. 9) and any portion of the self-expanding tube (31, Fig. 9) that remains in engagement with the elongate body during longitudinal movement of the elongate body towards a proximal end of the delivery system relative to the tubular member in use (Fig. 9, ¶0063). In this case, the Stinson device discloses all the claimed structural features and is considered to be capable of performing the functions of claim 12 (Figs. 2,8, & 9).
Regarding claim 14, Stinson teaches
wherein, in the retraction mode, the sum of the retaining force and a first longitudinal engagement force acting between the self- expanding tube (31, Fig. 9) and the tubular member (51, Fig. 9) is larger, with respect to opposing deployment of the self-expanding tube relative to the tubular member, than a maximum obtainable second longitudinal engagement force acting between the self-expanding tube and the elongate body (13, Fig. 9). In this case, the Stinson device discloses all the claimed structural features and is considered to be capable of performing the functions of claim 14 (Figs. 2, 8, & 9).
Regarding claim 15, Stinson teaches
wherein, in the retraction mode, a maximum obtainable first longitudinal engagement force acting between the self-expanding tube (31, Fig. 9) and the tubular member (51, Fig. 9) is smaller, with respect to opposing retraction of the self- expanding tube relative to the tubular member, than the sum of the retaining force and a second longitudinal engagement force acting between the self-expanding tube and the elongate body (13, Fig. 9). In this case, the Stinson device discloses all the claimed structural features and is considered to be capable of performing the functions of claim 15 (Figs. 2, 8, & 9).
Regarding claim 16, Stinson teaches
wherein the retaining member (21, Fig. 8) is configured to engage detachably with the proximal region of the self-expanding tube (Figs. 8-9).
Regarding claim 17, Stinson teaches
wherein the proximal region of the self- expanding tube (31, Fig. 5) comprises a proximal engagement member (32, Fig. 5), and the retaining member (21, Fig. 8) is configured to engage detachably with the proximal engagement member (Figs. 8-9).
Regarding claim 18, Stinson teaches
wherein the retaining member (21, Fig. 9) comprises a retaining tube radially positioned between the elongate body (13, Fig. 9) and the self-expanding tube (31, Fig. 9), and at least a portion of the self-expanding tube (31, Fig. 9) engages inwardly with the retaining tube and outwardly with the tubular member (51, Fig. 9).
Regarding claim 19, Stinson teaches
wherein the engagement of the proximal region with the retaining member (21, Fig. 9) is such that the proximal region disengages from the retaining member when the proximal region is deployed beyond a distal end of the tubular member (51, Fig. 9, ¶0063).
Regarding claim 25, Stinson teaches a method (¶0063) of deploying a self-expanding tube (31, Fig. 2, ¶0055) into a blood vessel (body lumen, ¶0063) comprising operating the delivery system of claim 1 in the deployment mode to deploy the self-expanding tube, wherein deploying the self-expanding tube comprises:
deploying a portion of the self-expanding tube (31, Fig. 9) by longitudinally moving the tubular member (51, Fig. 9) towards a proximal end of the delivery system relative to the elongate body (13, Fig. 9);
retracting the elongate body (13, Fig. 9) by longitudinally moving the elongate body towards a proximal end of the delivery system relative to the tubular member (51, Fig. 9); and
repeating the steps of deploying a portion of the self-expanding tube (31, Fig. 9) and retracting the elongate body (13, Fig. 9) until the self-expanding tube is released from the delivery system by self- expansion of the self-expanding tube (¶0063).
Regarding claim 26, Stinson teaches wherein:
the self-expanding tube (31, Fig. 2) is configured to self expand from a radially contracted state (Fig. 2) to a radially expanded state (Fig. 9) in a process involving longitudinal shortening of the self-expanding tube relative to a longitudinal axis of the tubular member (51, Fig. 9); and
the steps of deploying a portion of the self-expanding tube (31, Fig. 9) and retracting the elongate body (13, Fig. 9) are performed such that at no point during the deployment of the self-expanding tube does a distal end (17, Fig. 9) of the elongate body (13, Fig. 9) protrude beyond a distal end of the self-expanding tube by a distance greater than 2 times the length of the self-expanding tube in the radially expanded and longitudinally contracted state (Fig. 9).
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.
Claim(s) 20 & 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson in view of Tateshima (US 20150238278 A1).
Regarding claim 20, Stinson teaches a delivery system (11, Fig. 2, Stinson) for deploying a self-expanding tube (31, Fig. 2, ¶0055, Stinson) into a blood vessel (body lumen, ¶0063, Stinson), configured to operate in a deployment mode and comprising:
a tubular member (51, Fig. 2, Stinson) configured for insertion into the blood vessel (body lumen, ¶0063, Stinson);
an elongate body (13, Fig. 2, Stinson) extending within a lumen of the tubular member (51, Fig. 2, Stinson); and
a self-expanding tube (31, Fig. 2, Stinson) positioned radially between the tubular member (51, Fig. 2, Stinson) and the elongate body (13, Fig. 2, Stinson), wherein:
the self-expanding tube (31, Fig. 2, Stinson) comprises an elongate frame reversibly switchable from a radially expanded (Fig. 9, Stinson) and longitudinally contracted state (Fig. 2, Stinson) to a radially contracted and longitudinally expanded state (Fig. 9, Stinson).
Stinson does not teach markers. However, Tateshima teaches a micro-catheter delivery system that includes radio-opaque marker bands (abstract, Tateshima) wherein
a distal region (22, Fig. 2, Tateshima) of the elongate body (28, Fig. 2, Tateshima) comprises two end markers (30, Fig. 2, Tateshima), wherein a distance between the end markers is either or both of (i) equal to within 20% to the length of the self-expanding tube in the radially expanded and longitudinally contracted state (Fig. 2, Tateshima); and (ii) equal to within 2mm to the length of the self-expanding tube in the radially expanded and longitudinally contracted state (2 mm, ¶0033, Fig. 2, Tateshima).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Stinson with the above teachings of Tateshima in order to provide reference for an operator placing a braided stent (on the delivery system) (¶0033, Tateshima).
Regarding claim 27, Stinson teaches a method of deploying a self-expanding tube (31, Fig. 2, ¶0055, Stinson) into a blood vessel (body lumen, ¶0063, Stinson) comprising operating the delivery system of claim 20 in the deployment mode to deploy the self-expanding tube, wherein deploying the self-expanding tube comprises:
deploying a portion of the self-expanding tube (31, Fig. 9, Stinson) by longitudinally moving the elongate body (13, Fig. 9, Stinson) towards a distal end of the delivery system relative to the tubular member (51, Fig. 9, Stinson);
retracting the elongate body by longitudinally moving the elongate body towards a proximal end of the delivery system relative to the tubular member (¶0063, Stinson); and
repeating the steps of deploying a portion of the self-expanding tube and retracting the elongate body until the self-expanding tube is released from the delivery system by self- expansion of the self-expanding tube (¶0063, Stinson).
Stinson does not teach end markers. However, Tateshima teaches wherein:
during at least one repetition of the step of deploying a portion of the self-expanding tube (38, Fig. 9, Tateshima), the self-expanding tube is deployed by a distance equal to within 50% to the distance between the end markers (Fig. 9, Tateshima).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Stinson with the above teachings of Tateshima in order to allow the physician to ignore the elongation and simply use the 30 mm point marker as a reference for accurate placement (¶0042, Tateshima).
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson in view of Tateshima and further in view of Kusleika (US 20140121744 A1).
Regarding claims 22 & 23, Stinson in view of Tateshima does not teach a marker located on the distal/proximal end of the self-expanding tube. However, Kusleika teaches a vascular device that includes a mesh structure (abstract, Kusleika) wherein
the self-expanding tube (100, Fig. 1B, Kusleika) comprises a marker located at a distal/proximal end of the self-expanding tube (markers may be located adjacent the proximal or distal portions 105A, 105B or both of the medical device 100, Fig. 1B, ¶0089, Kusleika).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Stinson and Tateshima with the above teachings of Kusleika in order to permit a physician to accurately determine the position of the medical device 100 within a patient (¶0090, Kusleika).
Conclusion
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774