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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 27th 2026 has been entered.
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.
Claims 1, 2, 6-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cauthen et al. (US 2005/0283246).
Regarding claim 1, Cauthen et al. disclose an expandable mesh (600; Figures 57-62; ¶[0224]), comprising: a first coupling element (608); a second coupling element (604); an intermediate portion (at 600 in Figure 58) disposed between the first coupling element and the second coupling element, wherein the intermediate portion comprises a tubular length of the mesh defining a mesh interior (as with previous embodiments - ¶[0199]), wherein the first coupling element is positioned within the mesh interior (Figure 58) and the second coupling element is positioned external of the mesh interior prior to retraction of the first coupling element relative to the second coupling element (Figure 58), and wherein proximal retraction of the first coupling element relative to the second coupling element causes the intermediate portion to flare out to an enlarged width (¶[0226]; Figure 60); and a first tether (526) secured to the first coupling element and extending through the second coupling element (Figure 60), wherein proximal retraction of the first tether causes proximal retraction of the first coupling element relative to the second coupling element (¶[0226]; Note that Figures 66A and 73A-C, having an inverted shape, could be modified to use tether 1212 in Figure 29 and be readable by at least claim 1).
Regarding claim 2, the first coupling element comprises a first tube, and wherein the second coupling element comprises a second tube (evident from Figure 58).
Regarding claim 6, the expandable mesh comprises a delivery state in which the first and second tubes lack an axial overlap (Figure 58), and further comprises an expanded state in which the first and second tubes at least partially axially overlap (Figure 60).
Regarding claim 7, the expandable mesh comprises first (either end of 604) and second (proximal end of 608) ends, and further has a first state in which the first end is positioned proximal to the second end (Figure 58), and an everted second state in which the second end is positioned proximal to the first end (Figure 60).
Regarding claim 8, a distal end of the first tube transitions into a first end of the intermediate portion, and a second end of the intermediate portion transitions into a distal end of second tube (evident from Figure 58, a contacting connection between two objects can be regarded as one object transitioning into the other).
Regarding claim 10, one of first and second tubes comprises a constant diameter along its length, while the other of the first and second tubes comprises a tapered shape (see tapered proximal end of 608 forming a latch - Figure 58).
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.
Claims 3-5, 9, 11 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Cauthen et al. (US 2005/0283246).
Regarding claims 3-5, 23 and 25, the recited limitations are being treated as a product by process limitations; that is, as set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. The only structure which these claims require, and Cauthen et al. fail to specifically state, is the intermediate portion and coupling elements/tubes being made from the same material. However, Cauthen et al. disclose that the entire mesh device, including latching elements, can be made from a biodegradable polymer (¶[0202], [0243]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the entire mesh device including the coupling elements from the same biodegradable polymer in order to allow the body to remove the device without surgical intervention. The entire device being made from the same biodegradable material would also allow all of its components to degrade at the same or similar rate. The resulting device could be made by the claimed processes without causing any structural difference from the device disclosed by Clausen et al. Therefore the claimed processes do not provide any patentable difference from the device of Clausen et al. as modified above.
Regarding claim 9, Cauthen et al. fail to disclose for the above embodiment that the first and second tubes are dimensioned to be secured together using a friction fit when the first tube is proximally retracted relative to the second tube. However, Cauthen et al. disclose a coupling element being press fit (or friction fit) into another coupling element to lock a similar mesh device in an expanded state (Figure 71A; ¶[0241]) and disclose a version (Figures 66A-C) of the above embodiment which appears to have no latching mechanism as in Figure 60. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have dimensioned the coupling elements as claimed as a simple substitution of one known locking means (latching mechanism of Figure 60) for another (friction-fit of Figure 71A) to obtain predictable results (MPEP 2143 (I)(B)).
Regarding claim 11, Cauthen et al. disclose that the first tube is dimensioned to be disposed at least partially within the second tube when the first tube is proximally retracted relative to the second tube (Figure 60) and that the first tube has a tapered shape (see tapered proximal end of 608 forming a latch - Figure 58) but fail to disclose that the second tube comprises a tapered shape. However, Cauthen et al. disclose a very similar embodiment (Figure 30) where a similar second tube (1104) has a tapered outer diameter or shape (evident from Figure 30). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the second tube with the shape of the second tube in Figure 30 as a simple substitution of one known tube shape for another to obtain predictable results (MPEP 2143 (I)(B)).
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
