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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/218,959 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘959 application anticipate all the limitations of the claims of this application. Claim 1 of the ‘959 patent is narrower in scope than claim 1 of this application, as it recites the ends of the strand section are secured to the medical device. This limitation is in claim 2 of this application It is considered to be an obvious modification to broaden the scope of the claims and/or to put limitations from an independent claim into a dependent claim. The chart below details how the remainder of the claims correspond.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/613,673
18/218,673
1
1
2
1
3
2
4
7
5
4
6
5
7
5
8
7
9
8
10
9
11
12
12
13
Claims 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/218,959 (reference application) in view of USPAP 2005/0119722 (Styrc et al.).
Claim 1 of the ‘959 application anticipates all the structural limitations of claims 13-15. Although the claims of ‘959 do not recite the step of “pulling” a first portion of the first length of the strand to for a first loop and double-stranded tail, Styrc discloses that a filament wrapped about the exterior surface of an expandable medical device frame is a “tightening loop” [0043] that is pulled proximally to decrease the length of the loop around the device for securing it to the delivery device [0072]. Therefore, it would have been obvious to recite a step of pulling the strand to constrict the circumference of the medical device for delivery.
Claim Objections
Claim 7 is objected to because of the following informalities: claim 7 appears to be a duplicate of claim 6. Appropriate correction is required.
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.
Claim 9 is 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. Due to the term “optionally”, it is unclear whether a stent is required or not.
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, 6, 9, 10, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2005/0119722 (Styrc et al.) in view of USPAP 2005/0107862 (Ohlenschlaeger).
Styrc discloses a medical device system, comprising:
a tubular medical device (11) comprising a tubular body having a proximal end and a distal end;
a diameter reducing arrangement configured for constricting a diameter of the medical device, the diameter reducing arrangement including a strand section (33), a first length of the strand section extending from a first point of the strand section to a second point of the strand section (the Examiner notes that the points can be arbitrarily designated at any location along the length of the strand; see annotated figure below), the second point of the strand section being a first circumferential distance from the first point of the strand section by way of a path along the first length of the strand section; wherein, in a constricted configuration of the medical device, a first portion of the first length of the strand section extends back on itself to form a first double-stranded tail leading to a first loop (the first loop being formed at the knot (93) [0077]), the first double-stranded tail extending circumferentially against the graft body to constrict the medical device by the strand section restricting the first circumferential distance between the first and second points of the strand section.
Styrc fails to disclose a graft body on the medical device. Ohlenschlaeger discloses another delivery device comprising a retaining mechanism comprising a strand (retention loop 25) retained by a release wire (17) [0046], and teaches that the delivery device is used to constrain and deliver a stent-graft having a tubular graft body (13) (abstract). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to substitute the stent of Styrc with a stent-graft taught by Ohlenschlaeger, as the modification merely involves a substitution of one known implant for another that obtains a predictable result of constraining a stent-graft for delivery with a restraining loop mechanism.
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642
540
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Regarding claim 6, Styrc discloses the first circumferential distance traverses and defines a first circumferential region of the medical device, wherein in an expanded configuration of the medical device at least a majority of the first portion is disposed in the first circumferential region of the medical device (wherein “the region” generally corresponds in length with the first circumferential distance).
Regarding claim 9, the loop is retained by a release mechanism in the form of a retaining rod (31C/ 31D) [0096].
Regarding claim 10, the medical device of modified Styrc comprises a stent graft with a stent body attached at a proximal end.
Regarding claim 11, Styrc discloses the double-stranded tail passes through the wall of the medical device and is retained by a release mechanism internal to the graft body (see above).
Regarding claim 13, the modified Styrc assembly meets all the structural limitations of the claim. The step of “pulling” is met by Styrc’s disclosure of tightening the loop (circumferentially extending filament) [0052; 0093].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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