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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 fails to follow the conventional claim structure, i.e. “a plug comprising….” The claim should be amended to have a preamble, transition word, and positively recited limitations.
Appropriate correction is required.
Claim Interpretation
Claim language referring to a method of making (i.e., “formed by braiding and weaving” in claim 1) are only limiting insofar as they limit the structure of the device.
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 1-7 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 “expanded and developed.” It is unclear what is meant by “and developed.”
Claim 1 recites “formed by braiding and weaving.” However, it is not clear how a braid can be formed by braiding AND weaving.
Claim 1 recites “a plurality of wires regarded as one wire.” It is unclear what is meant by “regarded as one wire” as this appears to refer to the perception of the user. For the purposes of examination, based on the specification, it is assumed that this refers to the braiding pattern, that is, each “strand” in a braid actually comprises multiple wires, i.e. each strand is a multifilament strand. See Par. 0019.
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, 3, 5, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lubock et a. [US 2018/0242980 A1, hereinafter “Lubock”] in view of Cooper et al. [US 2019/0231361 A1, hereinafter “Cooper”].
Re. claim 1, as best understood, Lubock discloses:
An occlusion plug [10] that has a wire braided structure [“the expandable mesh is fabricated from a self-expanding filamentous braid (i.e., made of metallic wire,” Par. 0007], is formed to be thin so as to be insertable into a delivery catheter or a sheath in a stretched state [20, Fig. 2], and is expanded and developed in a radial direction in an open state [Fig. 3] to press [Par. 0055] and indwell in a blood vessel to embolize the blood vessel [Par. 0011, 0014], wherein the occlusion plug is formed by braiding and weaving a plurality of wires
Regarding the plurality of wires being “regarded as one wire” (see 112(b) above), Lubock is silent. However, Cooper teaches, in a vascular occlusion device, a braid made of a plurality of wires regarded as one [“metallic yarns” which are “multifilament” types, Par. 0079]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Lubock by forming the braid to be a multifilament braid as taught by Cooper in order to produce a “structure having desirable properties “ [Cooper Par. 0079].
Re. claim 3, Lubock discloses at least one of the plurality of wires has a different wire diameter [Fig. 8].
Re. claim 5, Lubock discloses the occlusion plug is formed in a disk shape when expanded and developed in an open state [Fig. 4].
Re. claim 6, Lubock discloses the occlusion plug has a plurality of disk portions that are formed in a disk shape when expanded and developed in an open state and are arranged in parallel [Fig. 4].
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lubock in view of Cooper, as applied to claim 1, and further in view of Trapp et al. [US 20080097401 A1, hereinafter “Trapp”]
Re. claim 2, Lubock is silent regarding the wires arranged side by side. However Trapp teaches the plurality of wires are arranged side by side in parallel [Figs. 13-14]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Lubock such that the wires are arranged side by side in parallel as taught by Trapp because this amounts to a simple substitution of one woven textile structure suitable in the art for another.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lubock in view of Cooper, as applied to claim 1, and further in view of Pavcnik et al. [US 20100312272 A1, hereinafter “Pavcnik”]
Re. claim 4, Lubock is silent regarding the claimed weave. However, Pavcnik teaches an occlusive device wherein the weaving has a structure of any of plain weave, twill weave, and satin weave [plain or satin, Par. 0078]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Lubock to use a plain or satin weave as taught by Pavcnik because this amounts to a simple substitution of one woven textile structure suitable in the art for another.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lubock in view of Cooper, as applied to claim 1, and further in view of Amplatz et al. [US 20080200945 A1, hereinafter “Amplatz”].
Re. claim 7, Lubock discloses the occlusion plug has three or more disk portions that are formed in a disk shape when expanded and developed in an open state and arranged in parallel [Fig. 3], but fails to teach the smaller disk diameter. However, Amplatz discloses an occlusive device having a plurality of disks wherein a diameter of the disk portion other than the disk portions at both ends is formed to be smaller than diameters of the disk portions at both ends [Fig. 11a]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Lubock such that the middle disk has a smaller diameter as taught by Amplatz in order to allow the device to be placed and held in specific areas such as in the aorta [Par. 0069, Figs. 11c-d]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-Th 9 am to 3 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
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