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 .
Election/Restrictions
Applicant's election with traverse of Species iii (Fig. 3) in the reply filed on 12/1/25 is acknowledged. The traversal is on the ground(s) that the species should be as follows:
Species a: Fig. 1 and 8-11
Species b: Fig. 2
Species c: Fig. 3, 4, 4a, and 5-7
This is found persuasive therefore the species will be considered as written by applicant. Therefore, the elected species is Species c (Fig. 3, 4, 4a, and 5-7).
The requirement is still deemed proper and is therefore made FINAL.
Claims 2, 3, 19, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/1/25.
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 and 4-18 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, “a catheter” in lines 12 and 23, however it is unclear if applicant is referring to the same or different catheter previously introduced in line 7. For purposes of this action, it will be considered as being the same.
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 and 4-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gorochow (2022/0031443).
Gorochow discloses the following claimed limitations:
Claim 1: A flow diverter stent apparatus having a substantially tubular body (100) (Fig. 5a-b) comprising: an at least one braided segment (108) (Fig. 5a-b and [0058]) and an at least one laser cut segment (502) (Fig. 5a-b and [0059-60]) engaged with one another in series so as to form an elongate flow diverter stent (Fig. 5a-b and [0058-60]); the at least one braided segment comprising: a plurality of individual strands (Fig. 4a-b and [0041-44]) braided together so as to form said braided segment (Fig. 4a-b and [0041-44]) having a proximal end (see figure below) and an opposing distal end (see figure below), said braided segment forming an elongated primary shape (shape seen in Fig. 4a-5b) capable of being inserted into a catheter (300) (Fig. 3a-f and [0050-51]) and having an inner diameter (inner diameter where blood would flow as best seen Fig. 4a-5b) along an entire segment length thereof between the proximal and distal ends (Fig. 4a-5b); and the at least one laser cut segment comprising: a single piece of laser cut material (section 106 in Fig. 5a-b and [0058-60]) having shape memory and super-elastic properties (Col. 5 Lines 29-32 of Gorochow (10,076,428) which is incorporated by reference as stated in [0061]) so as to form said laser cut segment capable of being inserted into a catheter (Fig. 3a-f and [0050-51]) and having a proximal end (see figure below), a distal end (see figure below), and a scaffold extending therebetween (the area between the ends forms the scaffold as seen in the figure below); the scaffold having a plurality of interconnected struts (see figure below) defining a plurality of radial axial rows of radial support cells (see figure below) and a plurality of flexible axial rows of flexible support cells (see figure below), such that the plurality of radial axial rows and the plurality of flexible axial rows are disposed in an alternating pattern along a circumferential axis of said laser cut segment (see figure below); and the proximal end of said laser cut segment providing a plurality of engagement cells (506, 550) arranged circumferentially about the proximal end of said laser cut segment (Fig. 5a-d), each of the engagement cells configured for engagement with at least one strand of the at least one braided segment at the distal end of the at least one braided segment (Fig. 5a-d and [0060-61]); whereby, during use of the apparatus, with the apparatus positioned within a catheter and moved to a target area of a patient's vascular system (Fig. 3a-f and [0050-51]), each of the at least one braided segment and at least one laser cut segment is configured for moving into a shape memorized secondary shape capable of filling the target area as the apparatus exits the catheter (Fig. 3a-f and [0050-51]).
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Claim 4: further comprising: a single braided segment (100) (Fig. 5a-b); and a single laser cut segment (502) (Fig. 5a-b) engaged with the distal end of the braided segment (Fig. 5a-b and [0058-60]).
Claim 5: wherein each of the radial support cells have the same size, shape and dimensions (Fig, 5b).
Claim 6: wherein each of the flexible support cells have the same size, shape and dimensions (Fig. 5b).
Claim 7: wherein: a center axis of each radial axial row and flexible axial row is parallel to a longitudinal axis of the at least one laser cut segment (see figure above where they are all parallel); each radial axial row is arranged so as to be offset along the longitudinal axis of the at least one laser cut segment from each adjacent radial axial row (see figure above); and each radial support cell is formed from four of the plurality of interconnected struts of the scaffold which are arranged so as to be symmetrical along both the longitudinal axis and the circumferential axis of the at least one laser cut segment (see figure above).
Claim 8: wherein: each of the engagement cells of the at least one laser cut segment is an arrangement of four struts (see figure below), wherein the struts are symmetrical along both a longitudinal axis and a circumferential axis of the at least one laser cut segment (see figure below); and the struts of each of the engagement cells define a joint apex (see figure below) that is oriented substantially longitudinally relative to the at least one laser cut segment (see figure below).
Claim 9: wherein the joint apex of each engagement cell is configured for engagement with one or more of the strands of the corresponding distal end of the at least one braided segment (see figure below and [0061]).
Claim 10: wherein the joint apex of each engagement cell is positioned so as to be in overlapping contact with and secured to a corresponding at least one strand of the at least one braided segment at the distal end of the at least one braided segment (see figure below and [0061]).
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Claim 11: wherein the engagement cells of the at least one laser cut segment are sized and configured for creating an at least one segment gap (gap between the two ends as seen in Fig. 5a-c) between the proximal end of the at least one laser cut segment and the distal end of the at least one braided segment (Fig. 5a-b).
Claim 12: wherein one or more of the at least one segment gap is sized for allowing at least one further instance of the apparatus to pass therethrough (Fig. 5a where it could be capable of receiving another apparatus therethrough).
Claim 13: wherein one or more of the radial support cells of the at least one laser cut segment are sized for allowing at least one further instance of the apparatus to pass therethrough (Fig. 5a where it could be capable of receiving another apparatus therethrough).
Claim 14: wherein one or more of the radial support cells of the at least one laser cut segment are sized for allowing a catheter to pass therethrough (Fig. 5a where it could be capable of receiving a catheter therethrough).
Claim 15: further comprising an at least one radiopaque element formed on the at least one laser cut segment (Col. 7 Lines 14-16 of Gorochow (10,076,428) which is incorporated by reference as stated in [0061]).
Claim 16: wherein at least one of the strands of the at least one braided segment is comprised of an at least one radiopaque material ([0044]).
Claim 17: wherein the at least one braided segment defines a plurality of braid gaps (gaps between strands as seen in Fig. 4a-5b) between strands along a segment length of the at least one braided segment (Fig. 4a-5b).
Claim 18: wherein the shape memorized secondary shape is at least one of a helical shape, a vortical shape, a flat spiral shape, a complex spiral shape, and a three-dimensional shape (Fig. 3a-5b where it is a three-dimensional shape).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited prior art appears to teach the claimed limitations when considered alone or in combination.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771