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 .
Priority
This application claims priority from provisional application 63/264,482, filed 11/23/2021.
Status of Claims
Claims 1-9, 11, and 17-20 are pending.
Claims 10 and 12-16 have been cancelled.
Information Disclosure Statement
The Information Disclosure Statement filed on 05/19/2024 has been considered by the examiner.
Claim Objections
Claim 19 is objected to because of the following informality, incomplete clause. Line 2 should be amended to recite “in the closed state with no central opening”.
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 1-9, 11, and 17-20 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.
Claim 1 is rendered indefinite by the second equation in line 13 because it contradicts the range defined in line 14. Specifically, line 13 defines a specific parameter where the pinwheeling score is defined as being 1, but line 14 requires the pinwheeling score within the range of 0.94-0.96. The applicant is advised to delete the second equation from line 13.
Claim 6 is rendered indefinite by the requirement for the midpoint of the free edge to be “slightly” raised. A person of ordinary skill in the art would not be able to determine the scope of slightly in this context. What degree of raised would and would not qualify as slightly? The applicant is advised to delete the word “slightly” from line 2.
Claim 19 is rendered indefinite by the requirement for full contact along the free edges of the valve leaflet in the closed state with no central opening and little to no overlap between the valve leaflets. As seen in Figures 2-3, the leaflets clearly overlap each other along their height. This seems to be consistent with how most prosthetic heart valves function. The inner cusp shaped portion and commissure attachment portions overlap each other when viewed from the side. Additionally, it is unclear if Figure 3 is the fully closed state or not because there still appears to be a central opening. Clarification is required.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter. The most relevant prior art is Matheny US 2011/0066237 A1. However, Matheny does not disclose the specific inner diameter dimensions or the thickness of the prosthesis. Matheny only discloses broad ranges for the length of the free edge of the leaflets and the ratios of these dimensions to a variety of diameters of the annulus. However, the ratios do not identify a specific combination of free edge length and inner diameter that provide the Pinwheeling score within the claimed range of 0.94 to 0.96. Additionally, there are no prior art references that disclose the claimed equation or specifically address Pinwheeling scores within the art of heart valves.
Claims 1-9, 11, and 17-20 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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