DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Species EE (Figures 47 & 47A) in the reply filed on 07/13/2026 is acknowledged.
Claims 26-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/13/2026.
Priority
Based on elected Species EE (Figures 47 & 47A), the priority dated for this Application is 02/07/2014, the filing date of Application 14/175,100 which is the first time, in the family of cases, the elected species was introduced.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 36-38 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Tuval et al. (US PG Pub. 2011/0208298), as disclosed in the IDS dated 05/07/2024, hereinafter Tuval.
Regarding claims 36-38, Tuval discloses a valve prosthesis (100) for implantation into a native valve site, illustrated in Figures 4E and 4F, comprising a valve body (118); and a frame (102) comprising a central portion supporting the valve body (118), the central portion configured to fit within an annulus of the native valve site, an inflow portion (IP) configured to engage an upstream side of the annulus and restrict movement of the valve prosthesis in a downstream direction of blood flow at the native valve site, first and second leaflet support arms (106) being configured to engage a native valve leaflet and restrict movement of the valve prosthesis in an upstream direction of blood flow at the native valve site, the second leaflet support arm (106) being diametrically opposed to the first leaflet support arm (106), first and second commissural engagement support arms (105A & 105B) extending from a distal end (118) of the frame to provide ventricular fixation of the valve prosthesis within the native valve site, each of the first and second commissural engagement support arms (105A & 105B) has a U-shape and are disposed side-by-side and positioned along a circumference of the central portion between the first and second leaflet support arms (106), and wherein the first and second commissural engagement support arms are configured to be deployed sequentially after deployment of the first and second leaflet support arms, illustrated in Figures 4E, 4F and modified figure 4E, below ([0124] & [0139], Last 7 Lines).
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Claims 36 and 37 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Ratz et al. (US PG Pub. 2014/0277390), as disclosed in the IDS dated 05/07/2024, hereinafter Ratz.
Regarding claims 36 and 37, Ratz discloses a valve prosthesis (10) for implantation into a native valve site, illustrated in Figures 1 and 5, comprising a valve body (60); and a frame (20) comprising a central portion (CP) supporting the valve body (60), the central portion configured to fit within an annulus (98) of the native valve site, an inflow portion (22) configured to engage an upstream side of the annulus (98) and restrict movement of the valve prosthesis in a downstream direction of blood flow at the native valve site, first and second leaflet support arms (FSA & SSA, respectively) being configured to engage a native valve leaflet (90) and restrict movement of the valve prosthesis in an upstream direction of blood flow at the native valve site, the second leaflet support arm (SSA) being diametrically opposed to the first leaflet support arm (FSA), first and second commissural engagement support arms (FCEA & SCEA, respectively) extending from a distal end (34) of the frame to provide ventricular fixation of the valve prosthesis within the native valve site, each of the first and second commissural engagement support arms (FCEA & SCEA) has a U-shape and are disposed side-by-side and positioned along a circumference of the central portion between the first and second leaflet support arms (FSA & SSA), illustrated in Figures 1, 5 and modified figure 1, below ([0019] & [0024]).
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Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 38 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ratz.
Regarding claim 38, Ratz discloses the valve prosthesis of claim 36, and though it is not specifically disclosed that the first and second commissural engagement support arms are deployed sequentially after deployment of the first and second leaflet support arms, this parameter is considered an intended use/functional parameter, which is considered to the extent of its structural limitations on the final structure of the valve prosthesis. In the instant case, the valve prosthesis of Ratz teaches all the structural limitations set forth in the claim(s) and there is nothing preventing the final structure of the valve prosthesis from meeting the intended use/functional parameter of having the first and second commissural engagement support arms are deployed sequentially after deployment of the first and second leaflet support arms, which can be adjusted based on delivery device and/or technique. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate delivery technique such that the valve prosthesis of Ratz would be delivered such that the first and second commissural engagement support arms are deployed sequentially after deployment of the first and second leaflet support arms.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at 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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/DINAH BARIA/Primary Examiner, Art Unit 3774 07/31/2026
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