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 .
Response to Amendment
In response to the amendment filed on 10/29/2024, claims 1-18 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the repair member in claim 6 and its associated details in claim 7-9 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 11, “each elastic positioning member” should recite - - each elastic positioning member of the at least two elastic positioning members - -. 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 1-18 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 “a sidewall of the self-expansion stent adjacent to the outlet flow end” in line 9. It is unclear if this sidewall is the same sidewall as the one first introduced in lines 7-8 (“a sidewall of the self-expansion stent”) or an additional/different sidewall or sidewall portion. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 1 as - - a sidewall portion of the sidewall of the self-expansion stent adjacent to the outflow end - -.
Claim 1 further recites “each elastic positioning member [of the at least two elastic positioning member]1 has a U-shaped portion and connecting arms located at two ends of the U-shaped portion” in lines 11-12. It is unclear how many connecting arms are located at each end of the U-shaped portion. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 1 as - - each elastic positioning member of the at least two elastic positioning member1 has a U-shaped portion comprising two ends and a connecting arm[[s]] located at each of the two ends of the U-shaped portion - -.
Claims 2-4, 7 recite “the connecting arm”. However, claim 1 required more than one connecting arm as each end of the U-shaped portion has a connecting arm. It is unclear which connecting arm claims 2-4, 7 are referring to, or if claims 2-4, 7 are referring to each of the connecting arm. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret the claims as - - each of the connecting arms - -.
Claim 2 recites the limitation "the outflow end grid" in lines 2, 4-6. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites “wherein three positioning members are provided”. It is unclear if these are three additional positioning members in addition to the “at least two elastic positioning members” recited in claim 1, or if there is a total of three positioning members. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 5 as - - wherein the at least two elastic positioning members comprise three elastic positioning members
Claim 12 recites “the support arm” in line 4. However, line 3 of claim 12 recites “support arms” and therefore introduce a plurality. It is therefore unclear in line 4 which support arm of the support arms is being referred to, or if the claim is referring to each of the support arms. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 12 as - - each of the support arms - -.
Claim 15 recites “the elastic positioning member”. However, claim 1 introduced “at least two elastic positioning members”. Therefore, it is unclear which positioning member is being referred to or if the claim is referring to each of the at least two elastic positioning members. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 15 as - - each of the elastic positioning member of the at least two elastic positioning members - -.
Claim(s) 6, 8-11, 13, 14, 16-18 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
Allowable Subject Matter
Claims 1-18 would be allowable if rewritten to obviate the 35 U.S.C. 112 rejection as interpreted by the Examiner above without altering the scope and if the drawing objections are obviated for claims 6-9 without introducing new matter.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, include Yan (CN 111329621; cited in the IDS filed 11/4/2024; a copy with the English machine translation attached herewith) and Eidenschin et al (EP 2921140; a copy attached herewith).
Yan discloses a transcatheter aortic valve replacement apparatus (Figs. 1-4), comprising a self-expansion stent (1), a valve skirt (3), a valve leaflet (2), at least two elastic positioning members (6), an outflow end release member (7); wherein a through-hole (“blood passage”) for liquid circulation is defined within the self-expansion stent; the self-expansion stent has an inflow end (4) and an outflow end (5) opposite to the inflow end, corresponding to the through-hole; and a sidewall of the self-expansion stent has a grid-shaped structure (Figs. 1, 4); wherein the valve skirt is connected to a sidewall of the through-hole (Fig. 1); wherein the valve leaflet is connected to an inner side of the valve skirt (“The petticoat 3 is installed inside the bracket 2 to increase the airtight performance”); a sidewall of the self-expansion stent adjacent to the outflow end is formed by a plurality of outflow end grids arranged in an annular shape (Fig. 1); each elastic positioning member (6) has a U-shaped portion and connecting arms located at two ends of the U-shaped portion (Figs. 1, 4); wherein each connecting arm is connected to the outflow end (Fig. 1); the U-shaped portion is located on an outer side of the self-expansion stent (Fig. 1); and a middle part of the U-shaped portion extends toward the inflow end and is elastically foldable (Fig. 1); and wherein the outflow end release member is connected to the outflow end of the self-expansion stent (Fig. 1).
Eidenschin et al discloses a transcatheter aortic valve replacement apparatus (Figs. 1A-1D), comprising both an outflow end release member (18) and an inflow end release member (30).
The prior art of record does not disclose or fairly suggest either singly or in combination the transcatheter aortic valve replacement apparatus having bilateral locking function comprising, inter alia, the outflow end release member (7) located between two of the elastic positioning members. Instead, the outflow end release member of Yan is located within a singular elastic positioning member and Eidenschin et al fails to teach any elastic positioning members as claimed. Applicant discuses the benefit of such a configuration of an inflow release member and an outflow end release member in [0015] of the published application, stating “the elastic positioning member and the outflow end release member are provided on the stent, and the positioning of the stent and the release of the outflow end are separate in function, and thus are independent from each other and do not affect each other, which effectively avoids the effective mounting of the positioning member and even the entire self-expansion stent from being affected when the stent is released by the outflow end release member. In addition, the outflow end release member is mounted between the elastic positioning members, which effectively ensures the compactness and stability of the whole apparatus. The outflow end release member and the inflow end release member can be fixed on the delivery system at both sides, and can be more conveniently mounted inside the delivery system.”
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
1 See claim objection above.
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