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 with traverse of Group I (claims 1, 4-8) in the reply filed on 03/30/2026 is acknowledged. The traversal is on the ground(s) that claim 1, as amended, contains features which are not taught or disclosed by Moszner, and therefore constitute a special technical feature that links the other groups via a single general inventive concept, and therefore the claims have unity of invention. This is not found persuasive because, as set forth below in the prior art rejection section, US 2019/0076136 A1 to Zhang et al. discloses all the features of amended claim 1. Accordingly, claim 1 does not constitute a special technical feature as it does not define over the prior art of Zhang. As previously established, the technical feature linking the groups is the subject matter of claim 1. Accordingly, since claim 1 does not constitute a special technical feature, the other groups lack unity of invention a posteriori. Therefore, the requirement is still applicable.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-12 and 15-24 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/30/2026.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1 and 4-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0076136 A1 to Zhang et al. (hereinafter “Zhang”).
Regarding claim 1, Zhang discloses woven single-riveting degradable implant (see [0078]) convertible between a compressed configuration (see [0026]) and a free configuration (Fig. 1; configuration for occluding septal defect as per [0022]-[0023]), comprising a first structure (20), a second structure (10), and a middle portion (30) provided between the first structure and the second structure (see Fig.1 and [0078]), wherein the implant is woven with weaving threads (see [0086]) made of a degradable material (see [0078]/[0081]); the first structure is provided with at least one connecting element (40), and the second structure comprises parabolas formed by a plurality of bent threads (see Fig. 4, parabola apexes formed at #14), each parabola being interlaced with two adjacent parabolas on the left and right to form a plurality of intersections (see Fig. 4, at closing line 15, adjacent parabolas interlace to form intersections), and having an apex (14) oriented toward one end of the second structure away from the middle portion and disposed on a circumference of a virtual circle (see Fig. 4, plurality of apexes 14 form a virtual circle circumference), so that said each parabola is tangent to the virtual circle at the apex (see Fig. 4), wherein the second structure is provided with a size-adjustable contractile opening at the one end of the second structure away from the middle portion in the free configuration (see Figs. 1/4 and [0078]), wherein the size-adjustable contractile opening is formed by at least one thread (closing line 15) passing sequentially through arcs where respective apexes of the parabolas are located in the second structure or through the plurality of intersections (see Fig. 1 and [0078]).
Zhang further discloses (claim 4) wherein the size-adjustable contractile opening has a diameter of 0-30 mm (see [0080]); (claim 5) wherein the size-adjustable contractile opening as well as cross-sections of the first structure, the second structure and the middle portion are centered on the same central axis (see Figs. 1-4).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of US 2007/0265656 A1 to Amplatz (hereinafter “Amplatz”).
Regarding claim 6, Zhang further discloses the connecting element is configured to be connected to a delivery device for the implant (see [0021]) and the connecting element formed by bundling the degradable thread material (see [0079]), the implant is provided with at least one auxiliary forming thread ("suture" [0096]) passing through any surface of the implant (see [0096]); and the implant is woven in such a way that M threads are pressed against N threads (see [0086]), and but fails to specifically disclose wherein any one of the first structure, the second structure and the middle portion is provided with at least one radiopaque marker. Amplatz discloses, in the same field of endeavor, an atrial septal defect occluder (see [0004]), comprising a first structure (12), a second structure (14), and a middle portion (16) between the first and second structures (see Figs. 1-4 and [0076]), wherein any of the first/second structure or middle portion is provided with at least one radiopaque marker (see [0098]/[0115]) for the purpose of making the device easily visualizable using fluoroscopy to help the physician orient the device as needed (see [0098]/[0115]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Zhang's device with the radiopaque marker taught by Amplatz in order to make the device easily visualizable using fluoroscopy to help the physician orient the device as needed.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Amplatz, as applied to claim 6 above, and further in view of US 2006/0224183 A1 to Freudenthal (hereinafter “Freudenthal”).
Regarding claims 7-8, the combination of Zhang and Amplatz discloses the invention substantially as claimed as discussed above, however, the combination fails to specifically disclose wherein the implant has a surface provided with a layer of a drug and/or a hydrophobic material and/or an anticoagulant drug for either inhibiting or promoting endothelialization. Freudenthal discloses, in the same field of endeavor, an atrial septal defect occluder (see [0104]), wherein the occluder can comprise a membrane structure ([0028]), wherein the membrane can comprise either a hydrophobic or hydrophilic material for either inhibiting or promoting endothelization (see [0028]) for the purpose of allowing the surgeon to determine whether tissue is intended to gather on the membrane-like structure (see [0028]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination's device with the membrane of Freudenthal as needed to allow the surgeon to determine whether tissue is intended to gather on the membrane-like structure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see the attached PTO-892 Notice of References cited for additional relevant prior art teaching occluder devices made of woven materials having ends which adjoin via woven parabolas.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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