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. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Claim Objections Claim 1 objected to because of the following informalities: Claim 1, Line 2 recites: “ in particular for the replacement of a native aortic valve ” however the limitation “in particular” is unnecessary. The Examiner suggests amending the claim language to remove the “in particular” language in order for the claims to clearly recite that the prosthetic heart valve is for heart valve defects or for the replacement of a native aortic valve. 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 appl icant regards as his invention. Claim s 1-11 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. Regarding Clai m 1 , the limitation “ wherein it also comprises connection means ” renders the claim indefinite because it is unclear whether Applicant is attempting to state that the prosthetic heart valve comprises the connection means or if Applicant is attempting to state that the valve prosthesis or the support structure comprises the connection means. For the purposes of examination, the Examiner will interpret this to recite “wherein the insertion tool comprises a connection means”. Furthermore, the claims are drawn to prosthetic heart valve and not a system for delivering a prosthetic heart valve and it is unclear whether the connection means of the insertion tool or the insertion tool itself is a positive recitation of the heart valve or if Applicant is attempting to functionally recite the insertion tool as capable of interacting with the prosthetic heart valve. Regarding Claim 8 , the limitation “ wherein it comprises a capsule ” renders the claim indefinite because it is unclear what “it” is referring to. For the purposes of examination, the Examiner will interpret this claim to recite “wherein the catheter comprises a capsule…”. The Examiner further notes that the claims are drawn to the prosthetic heart valve and therefore is is unclear if Applicant is attempting to positively recite the catheter as part of the prosthetic heart valve of if Applicant is attempting to functionally recite the catheter as it functions with the prosthetic heart valve. Claims 2-11 are rejected for incorporating errors from the parent claim by dependency. Claim Rejections - 35 USC § 102 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. The following is a quotation of the appropriate paragraphs of 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 – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 1-5 and 8 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Rothstein (US PGPub 2011/0264191) . Regarding Claim 1 , Rothstein teaches a prosthetic heart valve (Paragraph 0023) , of the self-expandable type (Paragraph 0028) , for the percutaneous correction of heart valve defects (Paragraph 0023) , in particular for the replacement of a native aortic valve (Paragraph 0023) , wherein said prosthetic heart valve (50; Figures 4-10) is suitable to be inserted into a catheter (24; Figure 1-8; Paragraph 0037) to be introduced into a body by means of an insertion tool (18; Figures 1-8; Paragraph 0032-0036) which can be associated with said catheter (24; Figure 1) , said prosthetic heart valve (50) comprising (Figure 10) a support structure (50; Figure 10) configured to self-expand in a substantially radial manner from a first compressed conformation when inserted into said catheter (24; Paragraph 0028 and 0048; Figure 8) , to a second expanded, or implant, conformation, when removed from said catheter (24; Paragraph 0028) , and a valve prosthesis (valve leaflets; Paragraph 0024) , configured to replace said native aortic valve, disposed inside said support structure (50; Figure 10; Paragraph 0025; Figures 4-5) , wherein it also comprises connection means (20; Figures 1, 5 and 9) which can be inserted into said catheter (21; Figure 1) and which can be connected, at a first end, or proximal end, to said insertion tool (18) and at a second opposite end, or distal end, to said support structure (50; Figures 4-5) in a removable manner (Paragraph 0046) , said connection means (20) being configured to allow the selective and reversible control (Paragraph 0046) , by means of said insertion tool (18) , of the conformation of said support structure (50; Paragraph 0046) . Regarding Claim 2 , Rothstein teaches the prosthetic heart valve as in claim 1, wherein said support structure (50) comprises an upper portion provided with attachment means (loop portions as best seen in Figure 19 when interact with capturing wires 14) which are configured to be attached to said native aortic valve with which said connection means (20/14) can be associated, and a lower portion that contains said valve prosthesis (as best seen in Figure 10) . Regarding Claim 3 , Rothstein teaches the prosthetic valve as in claim 2, wherein said upper portion comprises a plurality of connectors (See Figure 15 in which the connectors are the crowns which elements 14 are configured to attach to; Paragraph 0046) configured to be associated with said connection means (Figure 15) . Regarding Claim 4 , Rothstein teaches the prosthetic heart valve as in claim 3, wherein said connection means (20) are provided with coupling means (14) configured to connect in a removable manner to each of said connectors (crowns; see Figure 16; Paragraph 0046) . Regarding Claim 5 , Rothstein teaches the prosthetic heart valve as in claim 4, wherein said coupling means (14) comprise two arms hinged at the end of the respective connection means in order to rotate about an axis of rotation so as to be associated with said connectors (crowns of support structure 50) , their rotation being selectively controllable by said insertion tool (as best seen in Figures 18-19; Paragraph 0046-0047) . Regarding Claim 8 , teaches the prosthetic heart valve as in claim 2, wherein it (the catheter 24) comprises a capsule (distal end portion as seen in Figure 8) having a proximal portion (24) and a distal portion (12) connected to each other in a separable manner (See Figures 7-8) , wherein said upper portion of the support structure is contained in said proximal portion and said lower portion of the support structure is contained in said distal portion (as seen in Figures 7-8 wherein the upper portion of the support structure 50 is housed fully within sheath 24 and the lower portion is disposed about tip 12, which is the distal portion) . Claim Rejections - 35 USC § 103 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. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claim(s) 6, 7, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothstein (US PGPub 2011/0264191) as applied to claim 2 above, and further in view of Navia (US PGPub 2006/0259135) Regarding Claim 6 , Rothstein teaches the prosthetic heart valve as in claim 2, but fails to disclose wherein said attachment means comprise a ring-type structure which extroflects from said upper portion. Navia teaches an apparatus for replacing a native heart valve (abstract) comprising a support member (44e; Figure 20; Paragraph 0094) and a prosthetic heart valve (12; Figure 20; Paragraph 0024), wherein the support structure has an upper portion (110; Figure 20) and a lower portion (112; Figure 20), wherein the upper portion (110) has an attachment means which comprise a ring-type structure (114) which extroflects from said upper portion (110) (see Figure 20 in which elements 114 flexes outwards from the middle section). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Rothstein to include the teachings of Navia for the advantage of providing a magnetic ring component to further help secure the expandable support member to the native annulus of a heart valve (Paragraph 0100; Navia). Regarding Claim 7 , Rothstein teaches the prosthetic heart valve as in claim 2, but fails to disclose wherein said lower portion and said attachment means comprise a plurality of magnetic elements so that in said expanded conformation said plurality of magnetic elements of said lower portion and of said attachment means are sufficiently close for a magnetic attraction force to form between them. N avia teaches an apparatus for replacing a native heart valve (abstract) comprising a support member (44e; Figure 20; Paragraph 0094) and a prosthetic heart valve (12; Figure 20; Paragraph 0024), wherein the support structure has an upper portion (110; Figure 20) and a lower portion (112; Figure 20), wherein said lower portion (112) and said attachment means (110) comprise a plurality of magnetic elements (114 and 116; Figure 20; but see other embodiments of Figure 14 for example which show the same structure just not in ring form) so that in said expanded conformation said plurality of magnetic elements of said lower portion and of said attachment means are sufficiently close for a magnetic attraction force to form between them (as shown in Figure 18 but also as disclosed in Paragraph 0100 for Figure 20) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Rothstein to include the teachings of Navia for the advantage of providing a magnetic ring component in the upper portion and the lower portion to further help secure the expandable support member to the native annulus of a heart valve (Paragraph 0100; Navia). Regarding Claim 9 , Rothstein teaches the prosthetic heart valve as in claim 2, but fails to disclose wherein said lower portion has a flared shape. Navia teaches an apparatus for replacing a native heart valve (abstract) comprising a support member (44e; Figure 20; Paragraph 0094) and a prosthetic heart valve (12; Figure 20; Paragraph 0024), wherein the lower portion (56e; Figure 20) has a flared shape (Figure 20). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Rothstein to include the teachings of Navia for the advantage of providing a flared lower portion which helps form a connection between the inferior aspect of the native valve annulus (Paragraph 0073; Navia) Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothstein (US PGPub 2011/0264191) as applied to claim 2 above, and further in view of Suri (US PGPub 2009/00996533). Regarding Claim 10 , Rothstein teaches the prosthetic heart valve as in claim 2, but fails to disclose wherein said lower portion comprises a spongy casing suitable to reduce paravalvular leaks, or regurgitation. Suri teaches an expandable valve prosthesis comprising an upper portion and a lower portion, the lower portion comprising a spongy casing (70) suitable to reduce paravalvular leaks, or regurgitation (Paragraph 0024-0026). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Rothstein to include a spongy casing on the power portion, as taught by Suri, for the advantage of providing a seal between the expandable prosthetic heart valve and the inner surface of the native valve annulus (Paragraph 0025; Suri). Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothstein (US PGPub 2011/0264191) and Navia (US PGPub 2006/0259135) as applied to claim 6 above, and further in view of Chau (US PGPub 2011/0137397). Regarding Claim 11 , the combination of references disclosed above teaches the prosthetic heart valve as in claim 6, but fails to disclose wherein said ring-type structure is made of nitinol fibers intertwined to form a mesh suitable to filter debris released during implant operations. Chau teaches a prosthetic heart valve comprising a self-expanding frame (122; Figures 8-10; Paragraph 0096) comprising an upper portion having a ring-type structure (124; Figures 8-10; Paragraph 0096) which is configured to extroflects from the upper portion (Figures 8-10), the ring structure (124) is made of nitinol fibers intertwined to form a mesh suitable to filter debris released during implant operations (Paragraph 0096). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ring-type structure of the combination of references to include the teachings of Chau, for the advantage of providing a ring structure which integral to the support structure such that the ring structure is also self- expandable to its radially extroflected configuration (Paragraph 0096). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MOHAMED GAMIL GABR whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0569 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9am-5pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Jackie Ho can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-5953 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MOHAMED G GABR/ Primary Examiner, Art Unit 3771