CTNF 18/652,967 CTNF 86485 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. Drawings 06-22 AIA The drawings are objected to because figures 8 and 9a-c appear to have distinct elements labeled differently. For example, figure 8 shows the wedge 580 as being the circular structure in the figures, with item 504 being the support strip, whereas figures 9a-c show the item 504 as being two distinct structures, one of which is possibly a fabric located outside of the primary tab, but the other as being a somewhat compressed circular structure. Additionally, items 562 and 504 appear to be pointing to the same structures in figures 9a-c. The Examiner suggests reviewing the figures 8 and 9a-c and ensuring they are correctly numbered . 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. 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: “ expansion and locking mechanisms ” in claims 18-19. 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. This is accordingly considered to be “ a pair of axially aligned posts and a threaded rod extending through the pair of posts ” 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 § 112 07-30-02 AIA 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. 07-34-01 AIA Claim s 5-8, 14-16, 20-21 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. Claims 5-8, 14-16, 20-21 are indefinite for referring to a “wedge element”. A “wedge” is defined by Merriam-Webster as “a piece of a substance (such as wood or iron) that tapers to a thin edge and is used for splitting wood and rocks, raising heavy bodies, or for tightening by being driven into something; something wedge-shaped”. The specification defines the “wedge element” in [0102] as being “a relatively heavy gauge suture, such as a braided suture (e.g., an Ethibond suture), or a piece of fabric”. However, a suture or piece of fabric is neither understood to function or be shaped as is required by Merriam-Webster to be considered to be a wedge. Similarly, Applicant’s figures which show the “wedge element” (e.g. Figure 8-9c item 580) do not show any element that is wedge-shaped. The Examiner is accordingly unclear on what exactly is required for an element to be considered a “wedge element”, if it does not need to be shaped like a wedge, or function like a wedge. This claim term is accordingly unclear and its scope cannot be determined. Claim 16 is additionally indefinite for claiming that “the marker is the wedge element” when claims 12 and 16 already require the marker and the wedge to be distinct structural elements. As the claim is written, all parts of the claim cannot be met at the same time, since the marker cannot both be the wedge element, and also be separate from the wedge element. Remaining claims are rejected for depending on a rejected claim. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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 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. 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. 07-23-aia AIA The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 1-8, 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. (US 20120123529 A1) hereinafter known as Levi in view of Kaleta et al. (US 20210346154 A1) hereinafter known as Kaleta . Regarding claim 1 Levi discloses a prosthetic heart valve comprising:an annular frame comprising a plurality of struts (Figures 1-4 item 12), a plurality of leaflets arranged within the frame (Figure 2 item 40), at least one commissure (Figures 27-29 item 122; [0076]) comprising commissure tabs of two adjacent leaflets connected to each other (Figures 21-24, 26, and 29 item 116), the commissure being coupled to the frame (Figures 27 and 29; [0076]), but is silent with regards to the inclusion of a radiopaque marker. However, regarding claim 1 Kaleta teaches prosthetic heart valves can include at least one radiopaque marker separate from the frame attached to the commissure (Abstract), wherein the marker is configured to indicate a location of the commissure of the prosthetic heart valve ([0068]). Levi and Kaleta are involved in the same field of endeavor, namely prosthetic heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Levi to include a marker as is taught by Kaleta in order to assist the cardiac interventionalist in accurately implanting the valve within a patient easier, thus reducing the length of time of the surgery and so increasing safety for the patient. Regarding claim 2 the Levi Kaleta Combination teaches the valve of claim 1 substantially as is claimed, wherein Kaleta further discloses the marker is sewn to an exterior surface of the commissure that faces radially outward from the frame ([0096]). Regarding claim 3 the Levi Kaleta Combination teaches the valve of claim 1 substantially as is claimed, wherein Levi further discloses a flexible member which has a radially outward facing surface, and which is connected to the commissure tabs and forms part of the commissure (Figures 23-24, 27, 29, item 124). While Levi is silent with regards to the inclusion of a radiopaque marker, the Examiner refers to the rejection and combination with respect to claim 1 above, where the inclusion of a radiopaque marker on a commissure is known in the art (see Kaleta (Abstract)), and wherein Kaleta further teaches the marker can be sewn to attach the marker to the valve ([0096]). The person of ordinary skill in the art at the time the invention was filed would have found it obvious to include the marker anywhere within the extent of the commissure of the Levi Kaleta Combination, including the radially outward facing surface of the flexible member (124), since the precise radial location of the marker at the commissure is non-essential and since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. See MPEP 2144.04(VI)(C). As long as the marker stays at the commissure, its precise spot of attachment between layers is considered obvious to the person of ordinary skill to try. Regarding claim 4 the Levi Kaleta Combination teaches the valve of claim 1 substantially as is claimed, wherein Levi further discloses the frame comprises a plurality of commissure supports (Figure 11 item 60), each corresponding support defining a commissure window in the frame (Figure 11 item 62), wherein at least a portion of the commissure tabs extend radially through the window and are secured to and around outer surfaces of strut portions of the support defining the window (Figures 27, 29-30; [0076][0077], [0180]), and wherein the commissure includes a flexible member that covers outer surfaces of the commissure tabs on an exterior surface of the frame (Figures 23-25, 27, 29 item 124; [0076]). Regarding claim 5 the Levi Kaleta Combination teaches the valve of claim 4 substantially as is claimed, wherein Levi further discloses a wedge element that is disposed against outer surfaces of the commissure tabs exterior to the commissure window and at a location where the commissure tabs separate from one another to extend around outer surfaces of the strut portions of the commissure support (Figure 29 item 126), and wherein the wedge is disposed between the flexible member and the commissure tabs (Figure 29), but is silent with regards to the marker being the wedge. However, regarding claim 5 Kaleta teaches that the marker can be positioned at the commissure of a prosthetic valve (see the rejection to claim 1 above). While not disclosing the marker being the wedge, the person of ordinary skill at the time the invention was filed would have found it obvious to modify any part of the valve of Levi that is positioned at the commissure so that it radiopaque (including the wedge), since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B), and since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, having the wedge be radiopaque and so serve as the marker is simply substituting one material for another. Regarding claim 6 the Levi Kaleta Combination teaches the valve of claim 4 substantially as is claimed, wherein Levi further discloses a wedge element secured to the commissure tabs exterior to the commissure window and at a location where the tabs separate from one another to extend around outer surfaces of the strut portions of the commissure support (Figure 29 item 126), and wherein the wedge element is disposed between the commissure tabs and flexible member (Figure 29). Regarding claim 7 the Levi Kaleta Combination teaches the valve of claim 6 substantially as is claimed, but is silent with regards to the marker being disposed between the wedge element and flexible member. However, regarding claim 7 the person of ordinary skill in the art at the time the invention was filed would have found it obvious to include the marker anywhere within the extent of the commissure of the Levi Kaleta Combination, including between the wedge element (126) and the flexible member (124), since the precise radial location of the marker at the commissure is non-essential and since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. See MPEP 2144.04(VI)(C). As long as the marker stays at the commissure, its precise spot of attachment between layers is considered obvious to the person of ordinary skill to try. Regarding claim 8 the Levi Kaleta Combination teaches the valve of claim 6 substantially as is claimed, but is silent with regards to the marker being attached to an outer surface of the flexible member, the flexible member disposed between the marker and wedge element. However, regarding claim 8 the person of ordinary skill in the art at the time the invention was filed would have found it obvious to include the marker anywhere within the extent of the commissure of the Levi Kaleta Combination, including the outer surface of the flexible member (124) with the flexible member (124) being disposed between the marker and wedge element (126), since the precise radial location of the marker at the commissure is non-essential and since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. See MPEP 2144.04(VI)(C). As long as the marker stays at the commissure, its precise spot of attachment between layers is considered obvious to the person of ordinary skill to try. Regarding claim 10 the Levi Kaleta Combination teaches the valve of claim 1 substantially as is claimed, wherein the marker is rectangular with rounded edges (Figure 13 item 1638 shows a washer which is understood to take the shape of a rectangle with rounded edges). Levi and Kaleta are involved in the same field of endeavor, namely prosthetic heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the shape of the marker of the Levi Kaleta Combination so that it is rectangular with rounded edges as is taught by Kaleta since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). Regarding claim 11 the Levi Kaleta Combination teaches the valve of claim 1 substantially as is claimed, wherein Kaleta further teaches the marker is tantalum ([0081]). It would have been obvious to one of ordinary skill to have the marker comprise tantalum as is taught by Kaleta it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. Regarding claim 12 Levi discloses a prosthetic heart valve comprising: a frame with an inflow end (Figures 4-5 lower end of the frame 12 near row I), outflow end (Figures 4-5 upper end of the frame 12 near row V) and support posts (Figure 11 item 60) with a commissure window (Figure 11 item 62), a plurality of leaflets (Figure 2 item 40) arranged within the frame and configured to regulate a flow of blood through the frame in one direction between the inflow and outflow end (Figure 2; [0019]; see also Figure 43 for open leaflets and Figure 44 for closed leaflets), at least one commissure (Figures 27-29 item 122; [0076]) comprising commissure tabs of two adjacent leaflets connected to each other (Figures 21-24, 26, and 29 item 116), and extending radially through the commissure window of a corresponding support post wherein the commissure is connected to the corresponding support post (Figures 27, 29-30; [0076]), but is silent with regards to the inclusion of a radiopaque marker. However, regarding claim 12 Kaleta teaches prosthetic heart valves can include a radiopaque marker attached to the commissure (Abstract) which is configured to indicate a location of the commissure of the prosthetic heart valve ([0068]). Levi and Kaleta are involved in the same field of endeavor, namely prosthetic heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Levi to include a marker as is taught by Kaleta in order to assist the cardiac interventionalist in accurately implanting the valve within a patient easier, thus reducing the length of time of the surgery and so increasing safety for the patient. Regarding claim 13 the Levi Kaleta Combination teaches the valve of claim 12 substantially as is claimed, wherein Kaleta further teaches the marker is attached to the commissure exterior to the frame and on a radially outward facing surface of the commissure (Figure 13; [0096]). Regarding claim 14 the Levi Kaleta Combination teaches the valve of claim 12 substantially as is claimed, wherein Levi further discloses the commissure comprises a wedge element disposed against the commissure tabs on an exterior of the commissure window (Figure 29 item 126; [0076]), and a flexible member covering the commissure tabs on the exterior of the commissure window (Figures 23-25, 27, 29 item 124), the wedge element disposed interior to the flexible member relative to a central longitudinal axis of the frame (Figure 29 shows the wedge element 126 extending radially inward more than the flexible member 124 at its location), but is silent with regards to the marker being attached to the outer flexible member. However, regarding claim 14 the person of ordinary skill in the art at the time the invention was filed would have found it obvious to include the marker anywhere within the extent of the commissure of the Levi Kaleta Combination, including the outer surface of the flexible member (124), since the precise radial location of the marker at the commissure is non-essential and since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. See MPEP 2144.04(VI)(C). As long as the marker stays at the commissure, its precise spot of attachment between layers is considered obvious to the person of ordinary skill to try. Regarding claim 15 the Levi Kaleta Combination teaches the valve of claim 12 substantially as is claimed, wherein Levi further discloses the commissure comprises a wedge element disposed against the commissure tabs on an exterior of the commissure window (Figure 29 item 126; [0076]), and a flexible member covering the commissure tabs on the exterior of the commissure window (Figures 23-25, 27, 29 item 124), the wedge element disposed interior to the flexible member relative to a central longitudinal axis of the frame (Figure 29 shows the wedge element 126 extending radially inward more than the flexible member 124 at its location) but is silent with regards to the marker being disposed between the flexible member and wedge element. However, regarding claim 15 the person of ordinary skill in the art at the time the invention was filed would have found it obvious to include the marker anywhere within the extent of the commissure of the Levi Kaleta Combination, including between the flexible member (124) and wedge element (126), since the precise radial location of the marker at the commissure is non-essential and since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. See MPEP 2144.04(VI)(C). As long as the marker stays at the commissure, its precise spot of attachment between layers is considered obvious to the person of ordinary skill to try. Regarding claim 16 the Levi Kaleta Combination teaches the valve of claim 12 substantially as is claimed, wherein Levi further discloses the commissure comprises a wedge element disposed against the commissure tabs on an exterior of the commissure window (Figure 29 item 126; [0076]) and a flexible member covering the commissure tabs on the exterior of the commissure window Figures 23-25, 27, 29 item 124), the wedge element disposed interior to the flexible member relative to a central longitudinal axis of the frame (Figure 29 shows the wedge element 126 extending radially inward more than the flexible member 124 at its location), wherein the wedge is disposed between the flexible member and the commissure tabs (Figure 29), but is silent with regards to the marker being the wedge element. However, regarding claim 16 Kaleta teaches that the marker can be positioned at the commissure of a prosthetic valve (see the rejection to claim 1 above). While not disclosing the marker being the wedge, the person of ordinary skill at the time the invention was filed would have found it obvious to modify any part of the valve of Levi that is positioned at the commissure so that it radiopaque (including the wedge), since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B), and since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, having the wedge be radiopaque and so serve as the marker is simply substituting one material for another . 07-21-aia AIA Claim s 9, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi and Kaleta as is applied above, further in view of Peterson et al. (US 20210275298 A1), hereinafter known as Peterson . Regarding claim 9 the Levi Kaleta Combination teaches the valve of claim 1 substantially as is claimed, but is silent with regards to the marker being C-shaped. However, regarding claim 9 Peterson teaches a heart valve marker can be C-shaped ([0018]). Levi and Peterson are involved in the same field of endeavor, namely prosthetic heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the shape of the marker of the Levi Kaleta Combination so that it is C-shaped as is taught by Peterson in order to ensure the marker is rotationally non-symmetric, and thus allowing the cardiac interventionalist to easily identify the orientation of the valve during implantation. Regarding claim 17 the Levi Kaleta Combination teaches the valve of claim 12 substantially as is claimed, but is silent with regards to the marker being reflection asymmetric. However, regarding claim 17 Peterson teaches a heart valve marker can be C-shaped, and thus being reflection asymmetric across an axis that is parallel to a central longitudinal axis of the frame which extends between the inflow and outflow end of the frame ([0018]). Levi and Peterson are involved in the same field of endeavor, namely prosthetic heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the shape of the marker of the Levi Kaleta Combination so that it is C-shaped as is taught by Peterson in order to ensure the marker is rotationally non-symmetric, and thus allowing the cardiac interventionalist to easily identify the orientation of the valve during implantation . 07-21-aia AIA Claim s 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi and Kaleta as is applied above, further in view of Cohen et al. (US 20190060057 A1) hereinafter known as Cohen, and further in view of Peterson as is applied above . Regarding claim 18 the Levi Kaleta Combination teaches the valve of claim 12 substantially as is claimed, but is silent with regards to the frame having a plurality of mechanical expansion and locking mechanisms that are configured to radially expand and compress the frame. However, regarding claim 18 Cohen teaches a heart valve (Figure 1 item 100) a heart valve in which a frame (Figure 2 item 102) has support posts that each include one or more expansion and locking mechanisms (Figure 2 items 130) configured to radially expand or compress the frame ([0048]). Levi and Cohen are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Levi Kaleta Combination to include expansion and locking mechanisms as is taught by Cohen in order to assist the interventional cardiovascular surgeon in expanding the frame in question carefully and precisely in order to avoid over or under expansion, thus increasing the likelihood of a proper fit for the patient. Further, regarding claim 18 Peterson further teaches a heart valve can include posts alternating with commissure posts (Figure 38d item 3826 shows six posts/commissure posts). Levi and Peterson are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Levi Kaleta Cohen Combination so that the valve includes six posts as is taught by Peterson, since the addition of posts is known to add additional axial support to the stent, and thus increase stability when implanted. In this combination, the expansion and locking elements of Cohen are understood to either alternate with the posts of Peterson, or there are understood to obviously be six expansion and locking mechanisms, half of which are considered to be “posts” and half of which are considered to be “expansion and locking mechanisms” for the purposes of this claim. Regarding claim 19 Levi discloses a prosthetic heart valve comprising: a frame (Figures 1-4 item 12) comprising a plurality of support posts (Figure 11 item 60) including a commissure window (Figure 11 item 62), and being spaced apart around a circumference of the frame (Figures 4-5), a plurality of leaflets arranged within the frame (Figure 2 item 40) configured to regulate a flow of blood in one direction (Figure 2; [0019]; see also Figure 43 for open leaflets and Figure 44 for closed leaflets), at least one commissure (Figures 27-29 item 122; [0076]) comprising commissure tabs of two adjacent leaflets connected to each other (Figures 21-24, 26, and 29 item 116), and extending radially through the commissure window of a corresponding support post wherein the commissure is connected to the corresponding support post (Figures 27, 29-30; [0076]), but is silent with regards to there being a radiopaque marker attached to the commissure, and each support post including one or more expansion and locking mechanisms. However, regarding claim 19 Kaleta teaches a heart valve which includes a radiopaque marker attached to the commissure (Abstract), and Cohen teaches a heart valve in which a frame has support posts that each include one or more expansion and locking mechanisms (Figure 2 item 130) configured to radially expand or compress the frame ([0048]), each mechanism comprising a pair of axially aligned posts (Figure 2 items 136, 134) and a threaded rod extending through the posts (Figure 2 item 132; [0048] threaded rod). Levi and Kaleta are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Levi to include a marker as is taught by Kaleta in order to assist the cardiac interventionalist in accurately implanting the valve within a patient easier, thus reducing the length of time of the surgery and so increasing safety for the patient. Further, Levi and Cohen are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Levi Kaleta Combination to include expansion and locking mechanisms as is taught by Cohen in order to assist the interventional cardiovascular surgeon in expanding the frame in question carefully and precisely in order to avoid over or under expansion, thus increasing the likelihood of a proper fit for the patient. Further, regarding claim 19 Peterson further teaches a heart valve can include posts alternating with commissure posts (Figure 38d item 3826 shows six posts/commissure posts). Levi and Peterson are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Levi Kaleta Cohen Combination so that the valve includes six posts as is taught by Peterson, since the addition of posts is known to add additional axial support to the stent, and thus increase stability when implanted. In this combination, the expansion and locking elements of Cohen are understood to either alternate with the posts of Peterson, or there are understood to obviously be six expansion and locking mechanisms, half of which are considered to be “posts” and half of which are considered to be “expansion and locking mechanisms” for the purposes of this claim. Regarding claim 20 the Levi Kaleta Cohen Combination teaches the valve of claim 19 substantially as is claimed, wherein Levi further discloses the commissure comprises a wedge element disposed against and between the commissure tabs on an exterior of the commissure window (Figure 29 item 126; [0076]) and a flexible member covering at least a portion of the commissure tabs on the exterior of the commissure window (Figures 23-25, 27, 29 item 124), the wedge element disposed between the flexible member and the commissure tabs (Figure 29), but is silent with regards to the marker being attached to the outer surface of the flexible member that faces away from the frame or disposed between the flexible member and the wedge element. However, regarding claim 20 the person of ordinary skill in the art at the time the invention was filed would have found it obvious to include the marker anywhere within the extent of the commissure of the Levi Kaleta Cohen Combination, including on the outer surface of the flexible member (124), or between the flexible member (124) and wedge element (126), since the precise radial location of the marker at the commissure is non-essential and since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. See MPEP 2144.04(VI)(C). As long as the marker stays at the commissure, its precise spot of attachment between layers is considered obvious to the person of ordinary skill to try. Regarding claim 21 the Levi Kaleta Cohen Combination teaches es the valve of claim 19 substantially as is claimed, wherein Levi further discloses a wedge element that is disposed again and between the commissure tabs on an exterior of the commissure window (Figure 29 item 126), and wherein the commissure comprises a flexible member covering at least a portion of the commissure tabs on the exterior of the commissure window (Figures 23-25, 27, 29 item 124), the wedge (126) disposed between the flexible member (124) and commissure tabs (116) (Figure 29), but is silent with regards to the marker being the wedge element. However, regarding claim 21 Kaleta teaches that the marker can be positioned at the commissure of a prosthetic valve (see the rejection to claim 1 above). While not disclosing the marker being the wedge, the person of ordinary skill at the time the invention was filed would have found it obvious to modify any part of the valve of Levi that is positioned at the commissure so that it radiopaque (including the wedge), since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B), and since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, having the wedge be radiopaque and so serve as the marker is simply substituting one material for another. Regarding claim 22 the Levi Kaleta Cohen Combination teaches the valve of claim 19 substantially as is claimed, wherein Cohen further teaches the pair of axially aligned posts extend between an inflow end and outflow end of the frame (Figure 11 the posts extend the entire length of the frame and then further to attach to a delivery device), and are axially moveable relative to one another to permit the frame to radially expand or compress ([0048]). 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. 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, 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. 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. /Jacqueline Woznicki/Primary Examiner, Art Unit 3774 05/21/26 Application/Control Number: 18/652,967 Page 2 Art Unit: 3774 Application/Control Number: 18/652,967 Page 3 Art Unit: 3774 Application/Control Number: 18/652,967 Page 4 Art Unit: 3774 Application/Control Number: 18/652,967 Page 5 Art Unit: 3774 Application/Control Number: 18/652,967 Page 6 Art Unit: 3774 Application/Control Number: 18/652,967 Page 7 Art Unit: 3774 Application/Control Number: 18/652,967 Page 8 Art Unit: 3774 Application/Control Number: 18/652,967 Page 9 Art Unit: 3774 Application/Control Number: 18/652,967 Page 10 Art Unit: 3774 Application/Control Number: 18/652,967 Page 11 Art Unit: 3774 Application/Control Number: 18/652,967 Page 12 Art Unit: 3774 Application/Control Number: 18/652,967 Page 13 Art Unit: 3774 Application/Control Number: 18/652,967 Page 14 Art Unit: 3774 Application/Control Number: 18/652,967 Page 15 Art Unit: 3774 Application/Control Number: 18/652,967 Page 16 Art Unit: 3774 Application/Control Number: 18/652,967 Page 17 Art Unit: 3774 Application/Control Number: 18/652,967 Page 18 Art Unit: 3774 Application/Control Number: 18/652,967 Page 19 Art Unit: 3774 Application/Control Number: 18/652,967 Page 20 Art Unit: 3774 Application/Control Number: 18/652,967 Page 21 Art Unit: 3774 Application/Control Number: 18/652,967 Page 22 Art Unit: 3774 Application/Control Number: 18/652,967 Page 23 Art Unit: 3774 Application/Control Number: 18/652,967 Page 24 Art Unit: 3774 Application/Control Number: 18/652,967 Page 25 Art Unit: 3774 Application/Control Number: 18/652,967 Page 26 Art Unit: 3774
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