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 Species I, claims 1-19, in the reply filed on 9/21/2026 is acknowledged. Claim 20, directed to Species II, is withdrawn.
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 8-11 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 8 recites the limitation "a second angle" and claim 10 recites “a third angle. There is insufficient antecedent basis for these limitations in the claim. The term “second” and “third” would imply there is a first angle. However, no such first angle has been defined in claim 1. Therefore, in claims 8 and 10, it is unclear how many angles are required by the claims. The first angle is defined in claim 7, from which claim 8 is not presently dependent upon.
Claim(s) 9 and 11 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
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) 1, 2, 7, 15-15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al (US 2018/0021129) in view of Morriss et al (US 2020/0268508).
Claim 1. Peterson et al discloses a transcatheter heart valve prosthesis (6500) (Figs. 118-119) comprising:
a valve support (6544) ([0304]);
a prosthetic valve (3542) mounted within the valve support ([0304]);
an anchoring frame (6520) at least partially surrounding the valve support, wherein the anchoring frame and the valve support are attached to each other at respective inflow ends thereof (proximal end/upward end in Fig. 118)([0304], [0308]), wherein the anchoring frame includes a fixation portion (3528) configured to securely fix the anchoring frame to tissue at a native heart valve, an integration region (3527) configured to integrate the anchoring frame with the valve support, and a lateral portion (tapered portion between region 6527 and region 6528) extending between the fixation portion and the integration region ([0298]).
Peterson et al discloses an inflow end anchoring feature (6524) coupled to and extending radially outwardly from the anchoring frame at a transition between the lateral portion and the fixation portion ([0298], [0299]), extending around the circumference of the anchoring frame at the inflow end ([0297] discloses “the prosthesis 6500 can incorporate features and concepts which are the same as, or at least similar to, those of other frames described herein such as, but not limited to, prosthesis 100 described above in connection with FIG. 1”; wherein the earlier embodiment top views such as Fig. 2 illustrate the anchoring feature 226 at the inflow end extending around the circumference) but fails to explicitly disclose this anchoring feature is a brim.
However, in the same field of endeavor, Morriss et al teaches a heart valve prosthesis (100) comprising a brim (118; which includes sinusoidal rings 120A, 120B and sealing component 128) extending radially outwardly from the anchoring frame (102) at the inflow end ([0040]; Figs. 1A-1C). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the anchoring feature of Peterson et al to a brim as taught by Morriss et al to improve the sealing and anchoring characteristics of the prosthesis.
Claim 2. The combination discloses the invention substantially as claimed above, wherein Morriss et al discloses the brim (118) includes two sinusoidal rings (120A, 120B) and a sealing component (128) disposed over or covering at least a downstream surface of the sinusoidal rings (Figs. 1A-1C; [0040]).
Claim 7. The combination discloses the invention substantially as claimed above, wherein Peterson et al discloses the lateral portion flares radially outward (Fig. 118), in a direction from the inflow end to the outflow end, at a first angle relative to a central longitudinal axis of the anchoring frame, the first angle being between 40° and 60° ([0308] discloses the angle labeled θ from the horizontal axis can be about 140°; which translate to 50° from the central longitudinal (vertical) axis) therefore being within the claimed range.
Claim 12. The combination discloses the invention substantially as claimed above, but fails to disclose a first plurality of tissue engaging elements is disposed on an outer wall of the anchoring frame and extending towards the inflow end and radially outward, the first plurality of tissue engaging elements disposed on a node or an endmost outflow crown of the anchoring frame along the fixation portion.
However, Morriss et al further teaches a first plurality of tissue engaging elements (114) disposed on an outer wall of the anchoring frame (102) and extending towards the inflow end and radially outward, the first plurality of tissue engaging elements disposed on a node or an endmost outflow crown of the anchoring frame along the fixation portion (Fig. 1B; [0038]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to further include a first plurality of tissue engaging elements disposed on an outer wall of the anchoring frame and extending towards the inflow end and radially outward, the first plurality of tissue engaging elements disposed on a node or an endmost outflow crown of the anchoring frame along the fixation portion, as taught by Morriss et al, to improve the anchoring abilities of the fixation portion of the anchoring frame.
Claim 13. The combination discloses the invention substantially as claimed above, wherein Peterson et al further discloses a second plurality of tissue engaging elements (6526, 350; wherein this set of anchoring features are considered a ‘second’ plurality of tissue engaging elements in light of the modification from Morriss et al above adding in the first plurality of tissue engaging elements) disposed on an outer wall of the anchoring frame and extending towards the inflow end and radially outward, the second plurality of tissue engaging elements disposed on a node or an endmost outflow crown at the outflow end of the anchoring frame, wherein each tissue engaging element of the second plurality of tissue engaging elements has a hooked shape (Figs. 5, 118; [0224], [0298], [0299]).
Claim 14. The combination discloses the invention substantially as claimed above, wherein Peterson et al discloses the second plurality of tissue engaging elements extends around a circumference of the anchoring frame, at the outflow end of the anchoring frame (Figs. 5, 118; [0224], [0298], [0299]).
Claim 15. The combination discloses the invention substantially as claimed above, wherein Peterson et al disclose the second plurality of tissue engaging elements extends around between 135° and 170° of a circumference of the anchoring frame (Figs. 5, 118; wherein the term “comprises” is an open ended transition and thus the claim requires the second plurality of tissue engaging elements to extent at least around between 135° and 170° of a circumference of the anchoring frame and does not preclude the prior art from extending beyond 170°).
Claim 19. The combination discloses the invention substantially as claimed above, wherein Peterson et al disclose at least one clip (6422) disposed at the outflow end of the anchoring frame, wherein in a radially expanded state of the clip, the clip includes a pair of hinged curved portions (bottom curved portions closest to the fixation portion of the anchoring frame), each curved portion extending radially outward relative to the anchoring frame and being integrally formed with a U-shaped body of the clip that extends from the curved portions in an upstream direction, the U-shaped body including a peak (6426) and a pair of legs (6424a, 6424b) extending between the peak and curved portions, wherein the peak forms a proximal-most end of the clip and wherein when the clip is in the radially deployed state, the peak is disposed at a similar longitudinal depth as a junction between the fixation portion and the lateral portion of the anchoring frame (Figs. 115-117; [0294]-[0295]; wherein Fig. 115 shows the peak disposed near the transition/junction from the fixation portion to the lateral portion and is therefore considered to encompass the claimed limitation of “similar longitudinal depth”).
Allowable Subject Matter
Claims 3-6, 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Peterson et al in view of Morriss et al, discloses the invention substantially as claimed above.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed transcatheter valve prosthesis comprising, the structural features as described in claims 3-6, 8-11 and 16-18.
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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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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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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