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 without traverse of Group I and Species I (i.e. claims 1-8 and 16-20) in the reply filed on 07/21/2026 is acknowledged.
Claim(s) 1-4 and 16-18 is/are previously presented, claim(s) 5-15 and 19-20 is/are canceled. Accordingly, claim(s) 1-4 and 16-18 is/are examined herein.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, “the method comprising assembling a clamping portion of an exclusion device” should be changed to --the method comprising assembling a clamping portion of [[an]] the exclusion device-- . 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.
Claims 1-4 and 16-18 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 “assembling a clamping portion of an exclusion device comprising a beam and a biocompatible fabric cover; and securing .. of the cover” which is indefinite. It is unclear whether “biocompatible fabric cover” and “the cover” are the same single cover, or “the cover” refers to a different cover (e.g. a second cover or portion of the first cover). For the purpose of examination, the limitation examined below as the cover refers to the biocompatible fabric cover.
Claim 1, recites “a clamping portion”, “a beam” and “a biocompatible fabric cover” and requires ultrasonic welding “ a first portion of the cover to a second portion of the cover”. Claim 16 separately interduces “a first clamping portion”, “ as second clamping portion”, “a first beam”, “ a second beam”, “ a first biocompatible fabric cover” and “ a second biocompatible cover” without establish their relationship to the clamping portion, beam and cover of claim 1. It therefore unclear whether the first and second biocompatible fabric covers of claim 16 (a) together constitute “the cover” of claim 1, (b) include “the cover” of claim 1 as one of them or (c) are additional covers distinct from “the cover” of claim 1.
It is similarly unclear whether “the beam” of claim 1, on which the cover is secured, refers to the first beam, the second beam, both, or a further beam, and whether “the clamping portion” of claim 1 refers to the first clamping portion, the second clamping portion, or both. Because the claim is amendable to more than one plausible construction with differing scope, it is indefinite.
For the purpose of examination, claim 16 is interpreted as requiring the cover of claim 1 comprises the first and the second biocompatible fabric covers, that the first and second portions of the cover of claim 1 are respectively the first and the second biocompatible fabric covers, and that the clamping portion and beam of claim 1 encompass the first and second clamping portions of the beam.
Claim(s) 2-4 and 16-18 is/are rejected as being dependent from claim 1 and therefore including all the limitation thereof.
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) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fogo (US 2016/0174981) in view of Nguyen-Thien-Nhon (US 2017/0014229).
Regarding claim 1, Fogo teaches a method of making an exclusion device (implantable open-ended occlusion clips) for an anatomical structure (see Fig. 6; [0021]), the method comprising assembling a clamping portion of an exclusion device (100) comprising a beam (elongated occlusion arms 140, 150) and a biocompatible fabric cover (fabric tube (376)) (i.e. an opening of the fabric tube (376) is placed around a round distal end of the clip and slid proximally along the biasing arm and occlusion arm so that it surround both at once) (see Figs. 1-2 and Fig. 6; [0024-0025], [0037]); and securing the cover (376) on the beam by sewn shut … a first portion of the cover to a second portion of the cover (i.e. the cover (fabric tube (376) extends past the distal ends of the clip far enough to be sewn shut, and the sewn ends enclose the clip within the tube, sewing the tube end shut join one wall portion of the cover to another wall portion of the same cover, which secure the cover on the arms) (see Fig. 6;[0037]). However, Fogo does not explicitly teach that the cover portions are joined by ultrasonic welding.
In analogous art, Nguyen-Thien-Nhon teaches a method for making implantable prosthetic valve (Abstract; [0002] and [0016]), comprises joining fabric portions by ultrasonic welding in place of suture; wherein an outer skirt (18) is attached to an inner skirt (16) by ultrasonic welding in lieu of or in addition to sutures (see Fig. 3 and Fig. 23; [0071-0073]). Nguyen-Thien-Nhon further discloses that ultrasonic welding can provide several significant advantages. For example, ultrasonic welding can be relatively less time consuming and less expensive compared to suturing, while also providing improved strength (see [0073]).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have modified the apparatus as taught by Fogo with securing the cover on the beam by ultrasonic welding a first portion of the cover to a second portion of the cover as such is known in the art of implantable devices given the discussion of Nguyen-Thien-Nhon above; and doing so is simple substitution of one Known element for another to obtain predictable results, with the added benefits of doing so would relatively less time consuming and less expensive compared to suturing, while also providing improved strength (see [0073] of Nguyen-Thien-Nhon).
Regarding claim 2, Fogo in view of Nguyen-Thien-Nhon further teaches the method, wherein the ultrasonic welding operation comprises overlapping the first portion of the cover and the second portion of the cover; and applying ultrasonic energy to the overlapped first portion of the cover and the second portion of the cover to create at least one ultrasonic weld (i.e. forming each crease by overlapping adjacent portions of the outer skirt and securing them in the overlapped state by sutures, ultrasonic welding and an adhesive) (see Fig. 3 and Fig. 23; [0072-0073], [0083] of Nguyen-Thien-Nhon), and the at least one ultrasonic weld configured and arranged to facilitate tissue ingrowth into the cover proximate the at least one ultrasonic weld (i.e. Fogo’s cover is expressly a fabric chosen to allow biological tissue ingrowth, and it may be treated with collagen or albumin to promote ingrowth) (see [0009], [0037] and [0047] of Fogo).
Regarding claim 3, Fogo in view of Nguyen-Thien-Nhon teaches the method as discussed in claim 2 above.
Fogo further teaches the cover (376) is tubular and surrounds the occlusion arms (see Fig. 6; [0037] of Fogo), and Nguyen-Thien-Nhon further teaches the fabric tube by overlapping one edge portion with the opposite edge portion and joining them (see Fig. 3 and Fig. 23; [0072] of Nguyen-Thien-Nhon). Positioning the second portion “generally radially within” the first portion therefore represent one of only two possible orientations for a lap joint on a tubular cover(inner-over-outer-or outer -over-inner). Choosing between them would have been obvious to try, with a reasonable expectation of success. See MPEP§ 2143 (I) (E) for further details. Furthermore, a radially overlapped lap joint lets the welding energy be applied from the outside against the underlying support, which one of ordinary skill would have recognized as a predictable way to form the weld.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fogo (US 2016/0174981) in view of Nguyen-Thien-Nhon (US 2017/0014229) as applied to claim 2 above, and further in view of Kujawski (US 2005/0228489).
Regarding claim 4, Fogo in view of Nguyen-Thien-Nhon teaches the method as discussed in claim 2 above.
Fogo in view of Nguyen-Thien-Nhon does not teach, wherein applying ultrasonic energy to the overlapped first portion of the cover and the second portion of the cover comprises applying ultrasonic energy at about 40 kHz.
In analogous art of ultrasonically processing polyester implant fabric (vascular grafts), Kujawski teaches that ultrasonic welder commercially available from Branson and Dukane generally operate at a fixed frequency of 20,30, or 40 kHz (see [0023-0024]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to perform the ultrasonic welding at about 40kHz as such is known in the art of ultrasonic welding process given the discussion of Kujawski above presenting a reasonable expectation of success; and doing so is applying a known technique to a known device ready for improvement to yield predictable results, with the added benefit of doing so allows to ensure gentle yet effective welding of fabric layers without compromising their structural integrity or biocompatibility. Furthermore, weld frequency is a known process parameter that, together with amplitude, time, and pressure governs the energy delivered to the weld, and optimizing it would have been routine. MPEP2144.05(I).
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fogo (US 2016/0174981) in view of Nguyen-Thien-Nhon (US 2017/0014229) as applied to claim 1 above, and further in view of Williamson (US 2012/0059400).
Regarding claim 16, Fogo in view of Nguyen-Thien-Nhon teaches the method as discussed in claim 1 above.
Fogo further teaches assembling the clamping portion of the exclusion device includes assembling a first clamping portion comprising a first beam (140) with a .. biocompatible fabric cover (376), and assembling a second clamping portion comprising a second beam (150) with .. biocompatible fabric (376) (see Figs. 1-2 and Fig. 6; [0035-0037]). However, Fogo in view of Nguyen-Thien-Nhon does not explicitly teach assembling a first clamping portion comprising a first beam with a first biocompatible fabric cover, and assembling a second clamping portion comprising a second beam with a second biocompatible fabric cover.
In the same field of endeavor, method and apparatus for occlusions clips, Williamson teaches a clamp built includes assembling a first clamping portion (2) comprising a first beam with a first biocompatible fabric cover (77), and assembling a second clamping portion (4) comprising a second beam with a second biocompatible fabric cover (see Figs. 1A-1D, Fig. 3 and Fig. 5;[0053-0054] and [0058]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to assemble a first clamping portion comprising a first beam with a first biocompatible fabric cover, and assembling a second clamping portion comprising a second beam with a second biocompatible fabric cover as such is known in the art of exclusions devices given the discussion of Williamson above presenting a reasonable expectation of success; and doing so is applying a known technique to a known device ready for improvement to yield predictable results, with the added benefit of doing so allows for promoting tissue in growth and stability and to ensure proper function and integration by overlapping and positioning of fabric portions.
Modified Fogo in view of Nguyen-Thien-Nhon and Williamson further teaches securing the cover on the beam by ultrasonic welding the first portion of the cover to the second portion of the cover includes ultrasonic welding the first biocompatible fabric cover to the second biocompatible fabric cover (see Fig. 6; [0037] of Fogo and Fig. 3 and Fig. 23;[0071-0073] of Nguyen-Thien-Nhon).
Regarding claim 17, Fogo in view of Nguyen-Thien-Nhon teaches the method as discussed in claim 1 above.
Fogo further teaches the method, wherein: assembling the clamping portion of the exclusion device includes mounting a first spring (120) to a first beam (140) and mounting a second spring (130) to the second beam (150) (see Figs. 1-2; [0024]). However, Fogo in view of Nguyen-Thien-Nhon does not explicitly teach assembling the clamping portion of the exclusion device includes mounting a first spring to a second beam, and mounting a second spring to the first beam and to the second beam; assembling the clamping portion of the exclusion device includes encapsulating the first beam, the second beam, the first spring, and the second spring within the biocompatible fabric cover.
In the same field of endeavor, method and apparatus for occlusions clips, Williamson teaches a clamp built (10) includes assembling the clamping portion of the exclusion device includes mounting a first spring (66) to a first beam (63) and to a second beam (65), and mounting a second spring (68) to the first beam and to the second beam (see Fig. 3; [0056]); assembling the clamping portion of the exclusion device includes encapsulating the first beam, the second beam, the first spring, and the second spring within the biocompatible fabric cover (74)(see Fig. 5; [0058]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to assemble the clamping portion of the exclusion device includes mounting a first spring to a first beam and to a second beam, and mounting a second spring to the first beam and to the second beam; assembling the clamping portion of the exclusion device includes encapsulating the first beam, the second beam, the first spring, and the second spring within the biocompatible fabric cover as such is known in the art of exclusions devices given the discussion of Williamson above presenting a reasonable expectation of success; and doing so is applying a known technique to a known device ready for improvement to yield predictable results, with the added benefit of doing so allows for promoting tissue in growth and stability and to ensure proper function and integration by overlapping and positioning of fabric portions.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fogo (US 2016/0174981) in view of Nguyen-Thien-Nhon (US 2017/0014229) as applied to claim 1 above, and further in view of Collette (US 5,713,399).
Regarding claim 18, Modified Fogo in view of Nguyen-Thien-Nhon teaches the method, wherein securing the cover on the beam by ultrasonic welding the first portion of the cover to the second portion of the cover creates an ultrasonic weld (see Fig. 6; [0037] of Fogo; and Fig. 3 and Fig. 23; [0071-0073] of Nguyen-Thien-Nhon) but Fogo in view of Nguyen-Thien-Nhon does not teach that the ultrasonic weld includes a shape of an irregular periphery.
In analogous art of ultrasonically seaming polymeric fabrics, Collette teaches a method for manufacturing a papermaker's fabric by spirally winding a woven fabric strip and spirally continuous seam so obtained is closed by ultrasonically welding (Abstract), comprises forming a weld against an anvil knurled in a relatively deep pattern, so that spot weld are produced instead of a continuous weld (see Fig. 5; column 5, lines 50-54 and lines 65-67). Collette further discusses that a weld made up of discrete diamond-pattern spot-weld regions interspersed with unwelded fabric has discontinuous, non-uniform boundary (i.e. irregular periphery) (see column 5, lines 65-67).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the ultrasonic weld of the modified Fogo method with patterned, spot-type weld, and hence irregular periphery as taught by Collette in order to preserve the openness and porosity of the fabric at the seam (see column 5, lines 65-67 and column 6, lines 1-5 of Collette). One of ordinary skill would have recognized this as desirable in Fogo’s cover is chosen specifically to allow biological tissue ingrowth, which depends on fabric porosity. In addition, changing the shape of a weld is a matter of design choice absent of persuasive evidence that the particular configuration is significant. (Please see MPEP 2144.04 IV B for further details).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED K AHMED ALI whose telephone number is (571)272-0347. The examiner can normally be reached 10:00 AM-7:30 PM.
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/MOHAMED K AHMED ALI/ Examiner, Art Unit 1743
