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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/23/2026, 05/29/2026 are being considered by the examiner.
Response to Amendment and Arguments
Applicant’s amendment and arguments have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 112 issues.
Claim Objections
Claim 12 is objected to because of the following informalities: claim 12, lines 10, “into the hermetic” should be -- into the hermetic layer--. 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 23 and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 23 and 24 depend from claim 12. However, claim 12 is directed to a method of assembling a prosthetic heart valve, whereas claims 23 and 24 recite “The prosthetic heart valve of claim 12.” Accordingly, claims 23 and 24 improperly refer to an apparatus, namely a prosthetic heart valve, while depending from a method claim. As a result, it is unclear whether claims 23 and 24 are intended to further limit the method of claim 12 or instead are intended to claim a prosthetic heart valve. In particular, claim 23 recites: “The prosthetic heart valve of claim 12, wherein at least 90% of the pores have a size of 10 µm or less.” Claim 24 recites: “The prosthetic heart valve of claim 12, wherein at least 90% of the pores have a size of 5 µm or less.” Because claim 12 does not recite a prosthetic heart valve as the claimed statutory subject matter, but instead recites a method, the dependency of claims 23 and 24 renders the scope of these claims unclear. Therefore, claims 23 and 24 are indefinite.
Appropriate correction may include amending claims 23 and 24 to depend from claim 12 as method claims, for example:
23. The method of claim 12, wherein at least 90% of the pores have a size of 10 µm or less.
24. The method of claim 12, wherein at least 90% of the pores have a size of 5 µm or less.
Allowable Subject Matter
Claims 1-11, 13-19, 21 and 22 are allowed. Claim 12 is allowed with minor correction as indicated above.
The following is an examiner’s statement of reasons for allowance: The prior art of record fails to teach or reasonably suggest a prosthetic heart valve having a hermetic layer formed of a hydrophobic polymer material and configured with pores to discourage cellular ingrowth, wherein at least 90% of the pores have a size of 20 µm or less, as recited in independent claim 1.
The prior art also fails to teach or suggest the corresponding method limitation recited in independent claim 12. The prior art further fails to teach or reasonably suggest the combination recited in independent claim 13, including an inner hermetic layer formed of the claimed hydrophobic polymer material and having a pore structure in which at least 90% of pores have a size of 20 µm or less, in combination with an outer skirt having a first fabric layer with woven and floating structures and a second fabric layer disposed between the annular frame and the first fabric layer to isolate the floating structure from the annular frame.
The prior art of record may disclose prosthetic heart valves having frames, leaflets, skirts, liners, graft materials, and porous or low-porosity materials. However, the prior art does not teach or suggest the claimed pore-size distribution selected to discourage cellular ingrowth into the hermetic layer. Dependent claims 2–11, 14–19, and 21-22 are allowable by virtue of their dependence from allowable independent claims and because the prior art does not teach or suggest the additional limitations recited therein.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAN-UYEN THI HO whose telephone number is (571)272-4696. The examiner can normally be reached Normal Schedule M-F Between 7:00 am and 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, TAN-UYEN T HO can be reached at 7034745263. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAN-UYEN T HO/ Supervisory Patent Examiner, Art Unit 3771
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