CTNF 17/732,185 CTNF 91181 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-42-04 AIA 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/25/26 has been entered. Response to Amendment This action is entered in response to Applicant's amendment and reply of 2/25/26. The claims 1, 3-17, 19-21 are pending. The claims 1, 9, 10, and 17 are amended. Claims 6-8, 10-16, and 20 are withdrawn. Claim 21 is new. Response to Arguments 07-37 AIA Applicant’s arguments, filed 2/25/26 with respect to the rejections of claims 1, 3, 4, 9, 17, and 19 under 35 U.S.C. 103 as being unpatentable over Nitzan (US2009/0093876) in view of Desrosiers (WO2017/091605) have been fully considered but they are not persuasive. Applicant argues, the amendment “a majority of the transition element is located axially between the nosecone and a distal end of the prosthetic valve” is not taught by the prior art. Examiner disagrees, as stated in the rejection below . With regard to claim 17, Applicant argues the combination of Nitzan with Desrosiers does not teach “the at least one actuator assembly is configured to radially expand the valve”. Applicant further states the tines or arms 150 of Desrosiers connect a valve to the catheter and can be used to tilt the valve relative to the catheter. Examiner disagrees with Applicants arguments, where Applicant clarifies a single use of the tines or arms 150; however, it is capable of being used to perform other functions. Where the motion of the arms relative to each other ([061]) and the movement on the arms is capable of expanding the valve. Furthermore, one of ordinary skill in the art would have looked to Desrosiers to modify the assembly of Nitzaan to include the tines or arms 150 to reposition of move the valve for proper delivery. Where the structural components of the tines or arms 150 would be capable of performing the claimed function of radially expanding the valve and applying axially opposing forces since the tines or arms are intended to be moved relative to each other axially ([061]). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114. Applicant further argues, Desrosiers is silent regarding “mechanically expanding the prosthetic valve”. Examiner makes notice, Desrosiers is not relied upon for a teaching of “mechanically expanding the prosthetic valve” since Nitzan discloses the limitation by having the balloon inflated to expand the prosthetic valve . 07-30-03-h AIA Claim Interpretation 07-30-03 AIA 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. 07-30-05 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. 07-30-06 This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “transition element” in claims 1 and 17. The “transition element” is interpreted as a balloon, sponge, foam, or expandable frame (see instant specification paragraphs [007], [016], [017]) and equivalents thereof. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 1, 3, 4, and 9 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Nitzan (US2009/0093876) Regarding claim 1, Nitzan discloses an assembly, comprising a prosthetic valve (100, [0052]); and a delivery apparatus (assembly as shown in Figs. 5A-5D), comprising: an outer shaft (delivery catheter 110 with over tube 402, [0058]) with a distal end portion forming a sheath (over tube 402) adapted to enclose the prosthetic valve therein in a radially compressed configuration (see Fig. 5A, [0052]) an inner shaft (shaft 116) arranged within the outer shaft (shaft is within catheter 110, [0051], see Fig. 5A) and including a nosecone (tip 406, [0056], see Fig. 5A) arranged at a distal end of the inner shaft ([0056], see Fig. 5A), the nosecone arranged outside of the outer shaft (see Fig. 5A), at the distal end portion of the outer shaft (see Fig. 5A); and an expandable transition element (distal tapered portion of the balloon 112, see annotated Fig. 5D, where the portion of the balloon 112 is an equivalent structure under the 112(f) interpretation by being a portion of an inflatable balloon) adapted to expand from a non-expanded state (see Fig. 5A, [0054]) within the outer shaft to an expanded state (see Fig. 5D, [0059]) outside the outer shaft, wherein, in the expanded state, the transition element forms a continuous transition from the nosecone to the prosthetic valve when the sheath is moved away from the nosecone to uncover the prosthetic valve (where the continuous transition is interpreted as no gaps or spacing between the nosecone and the prosthetic valve, where the tapered portion 408 extends from the bioprosthesis 100 to the tip 406 of the balloon catheter 112, [0056], see Fig. 5D), and wherein, in the expanded state, a majority of the transition element is located axially between the nosecone and a distal end of the prosthetic valve (see annotated Fig. 5D). PNG media_image1.png 292 743 media_image1.png Greyscale Regarding claim 3, Nitzan discloses the assembly of claim 1, wherein the transition element is a balloon (112, [0056]). Regarding claim 4, Nitzan discloses the assembly of claim 3, wherein the balloon is an inflatable balloon that is inflatable from a deflated state (unexpanded balloon is not pressurized, [0044]) prior to removal of the prosthetic valve from the sheath (see Fig. 5A) to an inflated state (balloon is inflated by pressurizing device, [0040]) after removal of the prosthetic valve from the sheath (see Fig. 5D), wherein, when the balloon is in the deflated state, it is arranged within an interior of the sheath (see Fig. 5A), between the nosecone and a distal end of the prosthetic valve (402 extends over tapered portion 408 distal of bioprosthesis 100, [0056], see Fig. 5A), in the radially compressed configuration (see Fig. 5A), and wherein, when the balloon is in the inflated state, it is arranged exterior to the outer shaft and between the nosecone and a distal end of the prosthetic valve (see Fig. 5D, [0056]). Regarding claim 9, Nitzan discloses the assembly of claim 1, wherein, in an expanded state, a proximal terminal end of the transition element contacts a distal end of the prosthetic valve (see annotated Fig. 5D) and a distal terminal end of the transition element contacts a proximal end of the nosecone (see annotated Fig. 5D) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim 17, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan (US2009/0093876) in view of Desrosiers (WO2017/091605) . Regarding claim 17, Nitzan discloses an assembly, comprising a mechanically expandable prosthetic valve (100, [0052]; valve is at least capable of being mechanically expanded); and a delivery apparatus (assembly as shown in Figs. 5A-5D), comprising: an outer shaft (delivery catheter 110 with over tube 402, [0058]) with a distal end portion forming a sheath (over tube 402) adapted to enclose the prosthetic valve therein in a radially compressed configuration (see Fig. 5A, [0052]); an inner shaft (shaft 116) arranged within the outer shaft (shaft is within catheter 110, [0051], see Fig. 5A) and including a nosecone (tip 406, [0056], see Fig. 5A) arranged at a distal end of the inner shaft ([0056], see Fig. 5A), the nosecone arranged outside of the outer shaft (see Fig. 5A), wherein the outer shaft and the inner shaft are configured to move axially relative to one another to move the nosecone away from the distal end portion of the outer shaft and uncover the prosthetic valve ([0053], [0058]); and an expandable transition element (balloon 112, where the balloon 112 is an equivalent structure under the 112(f) interpretation by being a balloon) disposed between the prosthetic valve and the nosecone (see Fig. 5D), the expandable transition element adapted to expand from a non-expanded state (see Fig. 5A, [0054]) within the outer shaft to an expanded state (see Fig. 5D, [0059]) outside the outer shaft, wherein the transition element is in the non-expanded state when the sheath covers the prosthetic valve (see Fig. 5A) and the transition element and is in the expanded state when the sheath is moved away from the nosecone to uncover the prosthetic valve (see Fig. 5D) and wherein, in the expanded state, the transition element forms a continuous transition from the nosecone to the prosthetic valve (where the continuous transition is interpreted as no gaps or spacing between the nosecone and the prosthetic valve, where the tapered portion 408 extends from the bioprosthesis 100 to the tip 406 of the balloon catheter 112, [0056], see Fig. 5). Nitzan discloses wherein a distal end of the transition element is attached to a proximal end of the nosecone (see Fig. 5D); yet, is silent regarding wherein the delivery apparatus further comprises at least one actuator assembly arranged within the outer shaft and releasably coupled to the prosthetic valve, wherein the at least one actuator assembly is configured apply axially opposing forces to the prosthetic valve to cause the prosthetic valve to radially expand from a radially compressed state to a radially expanded state. Desrosiers teaches a release catheter 126 having a plurality of tines or arms 150, the arms 150 are coupled to prosthetic valve ([0075]) and released when the heart valve is delivered ([075]). Where the arms 150 are independently axially moveable relative to each other ([060]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have included an actuator assembly arranged within the outer shaft and releasably coupled to the prosthetic valve as taught by Desrosiers in order to reposition the prosthetic valve to align with the native annulus ([075]). Where the actuator assembly is configured to assist in radially expanding the prosthetic valve by actuation of the arms 150 ([087]). Examiner makes notice the at least one actuator assembly of Desrosiers is capable of applying axially opposing forces by forward and backward movement to reposition the valve. Furthermore, the tines or arms 150 are moveable axially independent of each other ([060]); therefore, one arm 50 could move proximally while the other is moved distally ([061]). Where this movement could assist in radially expanding the valve if the valve is positioned in a way that has not allowed the valve to fully expand. Regarding claim 19, Nitzan/Desrosiers makes obvious the assembly of claim 17, wherein the transition element is a balloon (112, [0056]). Regarding claim 21, Nitzan discloses the assembly of claim 1; yet, does not explicitly disclose wherein the delivery apparatus further comprises at least one actuator assembly arranged within the outer shaft and releasably coupled to the prosthetic valve, wherein the at least one actuator assembly is configured to apply axially opposing forces to the prosthetic valve to cause the prosthetic valve to radially expand from a radially compressed state to a radially expanded state. Desrosiers teaches a release catheter 126 having a plurality of tines or arms 150, the arms 150 are coupled to prosthetic valve ([0075]) and released when the heart valve is delivered ([075]). Where the arms 150 are independently axially moveable relative to each other ([060]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have included an actuator assembly arranged within the outer shaft and releasably coupled to the prosthetic valve as taught by Desrosiers in order to reposition the prosthetic valve to align with the native annulus ([075]). Where the actuator assembly is configured to assist in radially expanding the prosthetic valve by actuation of the arms 150 ([087]). Examiner makes notice the at least one actuator assembly of Desrosiers is capable of applying axially opposing forces by forward and backward movement to reposition the valve. Furthermore, the tines or arms 150 are moveable axially independent of each other ([060]); therefore, one arm 50 could move proximally while the other is moved distally ([061]). Where this movement could assist in radially expanding the valve if the valve is positioned in a way that has not allowed the valve to fully expand . 07-21-aia AIA Claim s 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nitzan (US2009/0093876) in view of Kwok (WO2018/232026) Regarding claim 5, Nitzan discloses the assembly of claim 3; yet, does not disclose wherein the balloon is a pre-inflated balloon, pre-inflated to an expanded state, that passively transitions between a compressed state when positioned within the sheath to the expanded state when the sheath is moved away from the balloon. Kwok teaches delivery of a valve prosthesis, where the prosthesis may be expanded by different alternatives ([0094]). One alternative being an expandable ball (balloon) that is made of a shell filled with compressed gel or fluid, and is self-expanded when released from constraint ([0094]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pre-inflated balloon that self-expands upon release from constraint as taught by Kwok for the balloon that is expandable by pressurizing, since the substitution would have yielded the same predictable result of providing an expandable member for expanding a prosthesis at the delivery site. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6. 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, Thomas Barrett can be reached on (571)272-4746. 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. /M.A.M/Examiner, Art Unit 3774 /THOMAS C BARRETT/SPE, Art Unit 3799 Application/Control Number: 17/732,185 Page 2 Art Unit: 3774 Application/Control Number: 17/732,185 Page 3 Art Unit: 3774 Application/Control Number: 17/732,185 Page 4 Art Unit: 3774 Application/Control Number: 17/732,185 Page 5 Art Unit: 3774 Application/Control Number: 17/732,185 Page 6 Art Unit: 3774 Application/Control Number: 17/732,185 Page 7 Art Unit: 3774 Application/Control Number: 17/732,185 Page 8 Art Unit: 3774 Application/Control Number: 17/732,185 Page 9 Art Unit: 3774 Application/Control Number: 17/732,185 Page 10 Art Unit: 3774
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