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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/21/26 has been entered.
Allowable Subject Matter
Claims 22-25 are allowed.
Election/Restrictions
Claims 22-25 are allowable. The restriction requirement among inventions, as set forth in the Office action mailed on 08/04/21, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 08/04/21 is partially withdrawn. Claims 26-27 and 29-35, directed to a prosthetic valve, are no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim. However, claims 16-21, directed to a coupling, remain withdrawn from consideration because they do not all require all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
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 “at least one coupling”, the coupling comprising “a guide 14”, the guide 14 comprising a slot 24, the guide 14 comprising a tube lumen, the connector 12 being receivable within the tube lumen, the tube lumen and the connector 12 having non-circular cross sections 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
Claims 29-30 are objected to because of the following informalities:
Claim 29 is objected to for referring to “the longitudinal axis” of the coupling, stented valve, and fixation element with improper antecedent basis.
Claim 30 is objected to for referring to “the longest dimension” of both the guide and stented valve with improper antecedent basis.
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 26-27 and 29-35 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 pre-AIA the applicant regards as the invention.
Claim 26 is indefinite for claiming that the stented valve and fixation element are each received by “at least one coupling” when it is unclear what this is and what it belongs to. The specification states that various parts of the coupling (e.g. the guide) can be a part of the stent itself, but claim 27 actually indicates the coupling comprises the guide which receives the stented valve, which makes it unclear whether the coupling belongs to the “prosthetic valve” as a whole, the “stented valve” specifically, or the “fixation element” specifically.
Claim 27 is indefinite for similar reasons, as it claims that the coupling comprises a guide 14. However, the specification shows and describes the guide as being a part of the stent, making it unclear how the guide is a part of the coupling element as well as part of the stented valve, while also receiving the stented valve. The relationship between the elements in claims 26-27 should be clarified.
Claim 29 is indefinite for claiming the longitudinal axes of the various valve elements are “substantially” coaxial when it is unclear from the specification what it means to be “substantially coaxial”. There are no examples which lead one of ordinary skill to understand what this phrase means, and how it differs, for example, from the axes being “coaxial” or not coaxial. Without guidance from the specification, the boundaries of the claim cannot be determined.
Claim 33 is indefinite for claiming the guide 14 comprises a slot 24, when the originally filed disclosure appears to show the guide 14 and slot 24 being completely separate elements. The figures also fail to show such a configuration, making their relationship to one another unclear.
Remaining claims are indefinite for depending on an indefinite claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/10/26
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