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 of Group II, claims 13-21, in the reply filed on 1/19/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 2-12 are withdrawn.
Drawings
Figures 1 and 2 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g).
Figs. 1-4, 6, 9, 11, 12, 13, 14 are objected to under 37 CFR 1.84 for the following reasons: lines are not uniformly thick and well defined. See the drawings from the parent applications which were acceptable. See CFR 1.84(l) which states “All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning”.
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: “beads 102A” in [0048] should recite - - bulbs 102A - - to keep the terminology consistent.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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) 13, 14 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frid et al (US 2010/0023113).
Frid et al discloses the following limitations:
Claim 13. A stent delivery device, comprising:
a pusher (13) including a proximal opening, a distal opening, and a lumen between the proximal opening and the distal opening ([0045]; guidewire 16 is seen extending through the lumen of pusher 13 in Fig. 13 from the proximal opening through the distal opening);
a core wire (16) movably positioned within the lumen of the pusher ([0032]); and
a mesh bulb (14) disposed over the core wire ([0032], [0033]), the mesh bulb comprising a proximal crimp point (at point 20) ([0045]; Figs. 12-14) and a distal crimp point (24) ([0048], [0049]; Figs. 12-14); and,
wherein the distal crimp point (24) is longitudinally movable over the core wire (16) ([0032]; “The applicator and the various elements described above slide along a guide wire 16 designed to bring the end of the applicator to the site of release of the endoprosthesis”).
Claim 14. The stent delivery device of claim 13, wherein the proximal crimp point (at point 20) is fixed to the pusher (13) ([0045]; by fusion or adhesive bonding 20).
Claim 21. A stent delivery device, comprising:
a pusher means (13) including a proximal opening, a distal opening, and a lumen between the proximal opening and the distal opening ([0045]; guidewire 16 is seen extending through the lumen of pusher 13 in Fig. 13 from the proximal opening through the distal opening);
a core wire (16) movably positioned within the lumen of the pusher (13) ([0032]); and
a bulb means (14) for expanding a stent (([0032], [0033]; stent 2 or any other hypothetical stent disposed over the bulb means as the stent is not positively recited as an element of the stent delivery device) disposed over the core wire, the bulb means comprising a proximal crimp point (at point 20) ([0045]; Figs. 12-14) and a distal crimp point (24) ([0048], [0049]; Figs. 12-14); and,
wherein the distal crimp point (24) is longitudinally movable over the core wire (16) ([0032]; “The applicator and the various elements described above slide along a guide wire 16 designed to bring the end of the applicator to the site of release of the endoprosthesis”); and,
wherein the proximal crimp point is fixed to the pusher (13) ([0045]; by fusion or adhesive bonding 20).
Claim(s) 13, 15, 16, 20 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ladd (US 6059814).
Ladd discloses the following limitations:
Claim 13. A stent delivery device, comprising:
a pusher (18) including a proximal opening, a distal opening, and a lumen (22) between the proximal opening and the distal opening (col. 4, ll. 46-48);
a core wire (28) movably positioned within the lumen of the pusher (18) (col. 4, ll. 58-63; rod 28 is a rod on the central axis of the device, having an outer diameter of 0.2mm and made of Nitinol, a metal alloy, and is therefore a thin metal rod and encompasses the claimed limitation of a ‘core wire’); and
a mesh bulb (46+50+52) disposed over the core wire (col. 5, ll. 28-45; the cited mesh bulb comprises a gortex fabric (wherein ‘fabric’ is defined as a material produced by weaving or knitting fibers) with perforations and thus encompasses the claim limitations of “mesh’), the mesh bulb comprising a proximal crimp point (42) and a distal crimp point (44); and,
wherein the distal crimp point (44) is longitudinally movable over the core wire (28) (col. 5, ll. 1-7).
Claim 15. The stent delivery device of claim 13, wherein the proximal crimp point (42) is fixed to the core wire (28) (col. 5, ll. 1-7; fixed to the outer wall 30 of core wire 28).
Claim 16. The stent delivery device of claim 13, further comprising a marker band (38) fixed to the core wire (28), the marker band being distal to the distal crimp point (44) (Fig. 1; col. 4, ll. 64-67).
Claim 20. The stent delivery device of claim 13, wherein a diameter of the lumen (22) of the pusher (18) is larger than a diameter or a width of each of the proximal crimp (42) point and the distal crimp point (44) (Fig. 1; col. 5, ll. 46-48).
Claim 21. A stent delivery device, comprising:
a pusher means (18) including a proximal opening, a distal opening, and a lumen (22) between the proximal opening and the distal opening (col. 4, ll. 46-48);
a core wire (28) movably positioned within the lumen of the pusher (18) (col. 4, ll. 58-63; rod 28 is a rod on the central axis of the device, having an outer diameter of 0.2mm and made of Nitinol, a metal alloy, and is therefore a thin metal rod and encompasses the claimed limitation of a ‘core wire’); and
a bulb means (46+50+52) (col. 5, ll. 28-45; the cited mesh bulb comprises a gortex fabric (wherein ‘fabric’ is defined as a material produced by weaving or knitting fibers) with perforations and thus encompasses the claim limitations of “mesh’) for expanding a stent disposed over the core wire (the cited bulb means is capable of expanding a hypothetical stent, which has not been positively recited as an element of the stent delivery device, disposed over the core wire), the bulb means comprising a proximal crimp point (42) and a distal crimp point (44);
wherein the distal crimp point (44) is longitudinally movable over the core wire (28) (col. 5, ll. 1-7); and,
wherein the proximal crimp point (42) is fixed to the core wire (28) (col. 5, ll. 1-7; fixed to the outer wall 30 of core wire 28).
Allowable Subject Matter
Claims 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Frid et al and Ladd, each individually discloses the invention substantially as claimed above.
In regards to claim 17, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed stent delivery device comprising, inter alia, in a bulb expansion configuration, the core wire is retracted such that the marker band contacts and proximally moves the distal crimp point along the core wire to expand a diameter of the mesh bulb. Instead, Ladd discloses retraction of the core wire (28) causes the diameter of the mesh bulb to decrease as the mesh bulb is pushed radially inward towards the core wire, since the proximal crimp point is also withdrawn into the lumen of the pusher (18). Rather, expansion of the mesh bulb occurs when the core wire (28) is pushed distally to allow for the mesh bulb to be free from the lumen of the pusher (col. 5, ll. 52-col. 6, ll. 8). The marker band of Ladd serves as a safety mechanism to prevent distal crimp point (44) from sliding off rod (28) in the event of a structural failure (col. 6, ll. 19-21).
In regards to claim 19, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed stent delivery device comprising, inter alia, in a bulb adjustment configuration, the core wire is advanced distally to reduce a diameter of the mesh bulb and retracted proximally to increase the diameter of the mesh bulb. Instead, Ladd discloses retraction of the core wire (28) causes the diameter of the mesh bulb to decrease as the mesh bulb is pushed radially inward towards the core wire, since the proximal crimp point is also withdrawn into the lumen of the pusher (18). Rather, expansion of the mesh bulb occurs when the core wire (28) is pushed distally to allow for the mesh bulb to be free from the lumen of the pusher (col. 5, ll. 52-col. 6, ll. 8). In Frid et al, the core wire (16) serves as a guidewire, and distal advancement or proximal retraction does not impact the diameter of the mesh bulb.
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 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, Darwin Erezo can be reached at (571)272-4695. 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.
/KATHERINE M SHI/Primary Examiner, Art Unit 3771