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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/07/2025 has been entered.
Response to Arguments
Applicant’s arguments have been fully considered and are persuasive.
Claim Objections
Claims 1-4, 16, and 24 objected to because of the following informalities:
Claim 1 recites “each arched atrial holding feature of the plurality of arched atrial holding features extends transversely outward in relation to the longitudinal axis, each of the anchor feet of the plurality of anchor feet extend transversely outward in relation to the longitudinal axis” but should recite “each arched atrial holding feature of the plurality of arched atrial holding features extends transversely outward in relation to the longitudinal axis, and each of the anchor feet of the plurality of anchor feet extend transversely outward in relation to the longitudinal axis.”
Claims 1-3 and 24 switch between limitation labels “supra-annular arched atrial holding features” and “arched atrial holding features,” the limitation labels should consistently recite “supra-annular arched atrial holding features”
Claims 1-2 switch between limitation labels “sub-annular anchor feet” and “anchor feet” the limitation labels should consistently recite “sub-annular anchor feet”
Claims 2, 4, and 16 switches between limitation labels “sub-annular foot” and “foot” the limitation labels should consistently recite “sub-annular foot”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 23 recites “located hub of the anchor frame of the prosthetic mitral valve system of claim 19, the eyelet of the SAM containment member adapted to fit on the first catheter in the pre-deployed configuration” however this configuration is not described in the specification.
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 9 and 21-22 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.
Claims 9 and 21 recites “three valve frame lobes” and “three anchor frame lobes but it is unclear from the claim language if these “frame lobes” are the same as the “supra-annular frame lobe” in claim 1. Clear and consistent limitation labels should be used.
Claims 21 and 22 recite a “first portion.” The specification does not further describe a “first portion,” the broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite.
Allowable Subject Matter
Claims 5-8, 10-15, 17-20, and 25-26 are allowed.
Claims 9 and 21-22 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 does not teach the prosthetic mitral valve system described in claim 1 wherein a first end of a first supra-annular frame lobe is coupled to a first end of a first supra-annular arched atrial holding feature at a first coupling point, the first coupling point being adjacent a first elongate element, and a second end of the first supra-annular frame lobe is coupled to a second end of the first supra-annular arched atrial holding feature at a second coupling point, the second coupling point being adjacent a second elongate element of the plurality of elongate elements, and the plurality of elongate elements defining a plurality of sub-annular anchor feet.
The closest prior art further fails to teach the prosthetic mitral valve system of claim 15 wherein a plurality of sub- annular retention features are coupled to the centrally located hub and including at least one systolic anterior motion (SAM) containment member defining an eyelet ,the eyelet being selectively coupled to the centrally located hub, wherein, while the expandable anchor frame is in the expanded configuration, each arched atrial holding feature of the at least three arched atrial holding features extends transversely outward in relation to the longitudinal axis and the at least one SAM containment member is uncoupled from the centrally located hub and extends outwardly in relation to the longitudinal axis.
Conclusion
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/H.L.P./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774