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 .
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
open cavity 202 (specification [0084]),
valve space (specification [0085] although with no reference sign),
valve housing retention space 222 (specification [0115]),
upper cavity opening 310 (specification [0086]),
hinge 360 (specification [0086]),
facing external surface 327 (specification [0114]).
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. 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.
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 1-20 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. The claims are indefinite because although the claim preambles indicate that the bioprosthetic heart valve is only functionally claimed, the bodies of each independent claim and of some of the dependent claims contain structural limitations on the claimed system that depend on the bioprosthetic heart valve, which suggests that the bioprosthetic heart valve is in fact positively claimed. For example only (with emphasis on the text in bold), claim 1 line 1 is specifically drafted to suggest that the heart valve is only recited functionally (note “system for dry storage of a bioprosthetic heart valve”). However, many structural limitations in claim 1 including those in claim 1 line 2 which recites that the valve housing is “dimensioned to removably retain a bioprosthetic heart valve”, and those in claim 1 lines 15-18 that requires “opposing surfaces of the inner side wall are spaced to compress only the compressible fabric of the bioprosthetic heart valve and not the stent such that a diameter of the stent remains substantially unchanged” depend on the heart valve, and therefore suggest that applicant’s intention is to claim the heart valve. See also the claim limitations in claim 1 lines 11-14 and 30-34 that structurally limit the claimed system by reference to the heart valve.
In other examples only, compare claim 13 line 1 with the “dimensioned” and “contacting” limitations in lines 4 and 7 respectively of the claim. See also dependent claim 16 and its further express limitations on the heart valve itself.
Therefore, the claims are found to be indefinite because they are drafted in such a way that it is not clear whether they are directed to the sub-combination of a system not including the heart valve or to the combination of a system and heart valve.
The examiner notes that it is by now well settled that features that are not claimed may not be relied upon by the applicant in support of patentability. In any event, for purposes of the comparison of the claims with the prior art, the claims have been interpreted as if they positively recite the heart valve, in order for the examiner to give effect to the structural limitations in the claims that depend on the heart valve. On the other hand, amendments to the claims are required to make clear that the heart valve is positively claimed.
Claims 1-20 would be allowable if rewritten or amended 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. As indicated above, in finding the claims allowable over the prior art the claims are read as if the heart valve is positively claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB K ACKUN whose telephone number is (571)272-4418. The examiner can normally be reached Monday-Thursday 11am-7pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Aviles can be reached at (571) 270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACOB K ACKUN/Primary Examiner, Art Unit 3736
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