Tuval, Yossi et al.Download PDFPatent Trials and Appeals BoardApr 29, 202012556368 - (D) (P.T.A.B. Apr. 29, 2020) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/556,368 09/09/2009 Yossi Tuval P0035145.01 2381 77218 7590 04/29/2020 Medtronic Vascular - APV Division c/o IP Legal Department 3576 Unocal Place Santa Rosa, CA 95403 EXAMINER SCHALL, MATTHEW WAYNE ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 04/29/2020 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): rs.docketingapv@medtronic.com rs.patents.five@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte YOSSI TUVAL, IGOR KOVALSKY, and ELI BEN HAMOU Appeal 2018-007690 Application 12/556,368 Technology Center 3700 Before JENNIFER D. BAHR, WILLIAM A. CAPP, and LISA M. GUIJT, Administrative Patent Judges. BAHR, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–20. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE and enter A NEW GROUND OF REJECTION. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Medtronic Ventor Technologies Ltd. (a subsidiary of Medtronic, Inc.) and Medtronic, Inc. as the real parties in interest. Appeal Br. 2. Appeal 2018-007690 Application 12/556,368 2 CLAIMED SUBJECT MATTER Appellant’s invention is directed “generally to prosthetic heart valves, and specifically to prosthetic heart valves configured for transfemoral delivery.” Spec. 1:10–12. Claim 1, reproduced below, is illustrative of the claimed subject matter. 1. Apparatus comprising a valve prosthesis for attachment to a native valve complex of a subject, the valve prosthesis comprising: a prosthetic heart valve; and a support frame, which is shaped so as to define: two or more commissural posts, to which the prosthetic heart valve is attached, wherein the commissural posts are arranged circumferentially around a central longitudinal axis of the valve prosthesis, and wherein each of the commissural posts extends in a downstream direction at a first radially outward angle with respect to the central longitudinal axis, a bulging upstream skirt, and a plurality of downstream axial support extensions, which join a downstream side of the upstream skirt, wherein each axial support extension extends in a downstream direction at a second radially outward angle with respect to the central longitudinal axis, the second radially outward angle greater than the first radially outward angle, and wherein the axial support extensions are configured to apply an axial force in an upstream direction to leaflets of the native valve complex. REFERENCE The prior art relied upon by the Examiner is: Name Reference Date Nguyen US 2005/0075717 A1 Apr. 7, 2005 Appeal 2018-007690 Application 12/556,368 3 REJECTIONS Claims 1, 2, and 5–16 stand rejected under 35 U.S.C. § 102(b) as anticipated by Nguyen. Claims 3, 4, and 17–20 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Nguyen. OPINION Prior Art Rejections Independent claim 1 recites, in pertinent part, “two or more commissural posts, to which the prosthetic valve is attached, wherein . . . each of the commissural posts extends in a downstream direction at a first radially outward angle with respect to the central longitudinal axis” and “a plurality of downstream axial support extensions” each extending “in a downstream direction at a second radially outward angle with respect to the central longitudinal axis, the second radially outward angle greater than the first radially outward angle.” Appeal Br. 23 (Claims App.). Claim 10 contains similar limitations, namely, “a plurality of commissural posts,” each of which “defines a first nonzero angle in a radially outward direction with respect to the central longitudinal axis” and “a plurality of axial support extensions,” each of which “defines a second nonzero angle[, greater than the first nonzero angle,] in the radially outward direction with respect to the central longitudinal axis.” Id. at 25–26. With reference to Figures 11 and 12 of Nguyen, the Examiner reads the claimed “commissural posts” on “any of the struts forming the posts; also the tabs (35).” Final Act. 3 (also citing “the struts forming commissure posts in figure 13”). As for the “axial support extensions,” the Examiner begins by reading this claim recitation on Nguyen’s vertical connecting Appeal 2018-007690 Application 12/556,368 4 elements 51 (id.), but then appears to rely on Nguyen’s flared inflow rim 47 as the “axial support extensions” (id.at 2). Finally, in the Answer, the Examiner provides an annotated version of Nguyen’s Figure 11 to identify the structure corresponding to the claimed “commissural posts” and “axial support extensions.” See Ans. 2–3. The Examiner’s annotated Figure 11, provided on page 3 of the Answer, is reproduced below. The annotated Figure 11 is rotated 90 degrees counterclockwise, and the annotations provided by the Examiner include, in pertinent part, two arrows on the left. The lower left arrow points to the bottom of one of diamonds 49 of outflow rim 48 of the anchoring structure, and the upper left arrow points to an intermediate location on the lower left leg (or side) of diamond 49.2 The Examiner considers the portion of this lower leg of 2 The Examiner’s discussion of the annotated figure refers to a “red arrow” and a “blue arrow” (Ans. 2–3), but the annotated figure includes only gray Appeal 2018-007690 Application 12/556,368 5 diamond 49 above the upper left arrow and the vertical portion of hexagon shaped element 50 extending from this lower leg together to form a “commissural post.” Ans. 2. Specifically, the Examiner explains that the posts are considered by the examiner to begin near the red arrow, and they are extending radially outward for at least a portion of the post. The rest of the posts then extend roughly parallel to the longitudinal axis of the device, however, at least a portion of the posts do not. Id. The Examiner finds that the axial support extensions extend from the point of the lower left arrow to the point of the upper left arrow. Id. at 3. According to the Examiner, these extensions “are clearly extending radially outward from the longitudinal axis of the device, and they are extending outward at a greater angle than the portion of the commissural posts near the [upper left] arrow shown.” Id. Appellant points out that leaflets 36 of Nguyen’s prosthetic valve are attached to commissural tabs 35. Reply Br. 5. Appellant’s position appears to be that Nguyen’s tabs 35, and not any portion of outflow rim 48, correspond to the claimed “commissural posts.” See Reply Br. 2–5. Appellant further contends that, even if one were to consider the strut directly attached to each tab (35) as the commissural post, that strut is parallel to the central longitudinal axis, not extending in a downstream direction at a first radially outward angle with respect to the central longitudinal axis, as recited in claim 1, nor defining a arrows. Like Appellant, we understand the “red arrow” to be a reference to “the uppermost arrow on the left hand side” of the figure and the “blue arrow” to be a reference to “the lower arrow on the left side” of the figure. See Reply Br. 5, 7. Appeal 2018-007690 Application 12/556,368 6 first nonzero angle in a radially outward direction with respect to the central longitudinal axis, as recited in claim 10. Id. at 7. Appellant argues that the strut of diamond 90 on which the Examiner relies for the portion of the post purportedly extending radially outward relative to the central longitudinal axis of the valve prosthesis is not even the portion of rim 48 attached to commissural tab 35 and, thus, would not reasonably be considered to be part of the commissural post as recited in claims 1 and 10.3 See Reply Br. 6. Appellant also submits that “the Examiner’s use of the side view of FIG. 11 is misleading.” Id. In discussing the embodiment of Figures 11 and 12, Nguyen expressly discloses that “commissural tabs (35) of the valve (32) can be stitched directly to the hexagon elements (50) of the outflow ring, rather than being secured via slots” as shown in other embodiments. Nguyen ¶ 103; see, e.g., id., Fig. 6C (showing axially extending slot 21 and suture bores 41 at the distal end of support post 22), Fig. 8 (showing axial slots 21 in support posts 22), ¶¶ 90–91, 94 (describing Figures 6C and 8, respectively). Thus, we are not persuaded that the portions of Nguyen’s outflow rim 48 to which tabs 35 are attached cannot reasonably be considered to be “commissural posts.” However, even assuming that one would consider the “commissural post” to extend all the way down to the Examiner’s upper left arrow,4 as the 3 Claim 1 defines the commissural posts as components of the support frame “to which the prosthetic heart valve is attached,” and claim 10 defines the commissural posts as components of the support frame “configured to have a prosthetic valve attached thereto.” Appeal Br. 23, 25 (Claims App.). 4 Note the new ground of rejection set forth below highlighting the ambiguity with respect to the terminology “commissural post” and “axial support extension.” Appeal 2018-007690 Application 12/556,368 7 Examiner posits, for the reasons that follow, we agree with Appellant that the Examiner’s use of Figure 11 is misleading, and we determine that the Examiner fails to establish by a preponderance of the evidence that the identified portions of Nguyen’s outflow rim 48 satisfy the limitations of the “commissural posts” and “axial support extensions” recited in either claim 1 or claim 10. The Examiner’s finding that Nguyen’s outflow rim defines a post extending radially outward for at least a portion of the post near the upper left arrow and an axial extension extending radially outward at a greater angle than the portion of the post near the upper left arrow shown appears to be premised on an assumption that the lower leg of diamond 90 to which the Examiner’s upper and lower left arrows point bends such that its radially outward angle with respect to the central longitudinal axis changes. However, it is not sufficiently clear that this is the case, nor is it clear whether the upper legs of the diamonds extend radially outwardly at all. See Fig. 12 (not showing any curvature in the legs of the diamonds). As can be seen more clearly in Figure 12 of Nguyen, the leg of diamond 90 to which the upper and lower arrows in the Examiner’s annotated Figure 11 point are not the portions of diamond 90 forming the bottom of hexagon element 50. Rather, the top legs of diamonds 90 form the bottoms of hexagon elements 50 and extend to the vertically extending segments (connecting adjacent hexagon elements) to which commissural tabs 35 are attached. These segments, as the Examiner acknowledges, “extend roughly parallel to the longitudinal axis of the device” (Ans. 2), and, thus, do not extend at a radially outward angle with respect to the central longitudinal axis, as recited in claim 1, or define a nonzero angle in a radially outward direction with Appeal 2018-007690 Application 12/556,368 8 respect to the central longitudinal axis, as recited in claim 10. In short, the Examiner fails to establish by a preponderance of the evidence that Nguyen’s outflow rim 48 has different portions extending radially outwardly at two different angles with respect to the central longitudinal axis, as called for in claims 1 and 10. It is not clear whether the Examiner maintains the finding, set forth on page 2 of the Final Action, that there are “struts forming commissure posts in [F]igure 13” of Nguyen. However, the struts forming post 52 (including those of diamond shaped element 55 and distal end 54) appear to suffer from a similar infirmity to the struts relied on in annotated Figure 11, discussed above. Further, the Examiner does not make any finding as to whether the structure of Nguyen on which the Examiner reads the claimed “axial support extensions” (whether vertical connecting elements 51 as set forth on page 3 of the Final Action, inflow rim 47 as set forth on page 2 of the Final Action, or the portion of diamond 90 identified by the Examiner on pages 2–3 of the Answer) “are configured to apply an axial force in an upstream direction to leaflets of the native valve complex,” as recited in claim 1. Appeal Br. 23 (Claims App.). Thus, the Examiner does not set forth sufficient factual findings to establish a prima facie case of anticipation of the subject matter of claim 1. For the above reasons, we do not sustain the rejection of claims 1 and 10, or their dependent claims 2 and 5–16, as anticipated by Nguyen. The deficiencies in the anticipation rejection also pervade the obviousness rejection of claims 3, 4, and 17–20 based on Nguyen. See Final Act. 4. Appeal 2018-007690 Application 12/556,368 9 Accordingly, we do not sustain the rejection of claims 3, 4, and 17–20 as unpatentable over Nguyen. NEW GROUND OF REJECTION Indefiniteness: Claims 1–20 Pursuant to 37 C.F.R. § 41.50(b), claims 1–20 are rejected under 35 U.S.C. § 112, second paragraph, as indefinite. “As the statutory language of ‘particular[ity]’ and ‘distinct[ness]’ indicates, claims are required to be cast in clear – as opposed to ambiguous, vague, indefinite – terms.” In re Packard, 751 F.3d 1307, 1313 (Fed. Cir. 2014) (citation omitted). Claims, when read in light of the specification, must “reasonably apprise those skilled in the art both of the utilization and scope of the invention” using language “as precise as the subject matter permits.” Id. In determining whether a claim is definite under 35 U.S.C. § 112, second paragraph, “[t]he USPTO, in examining an application, is obliged to test the claims for reasonable precision according to [this principle].” Id. Although, for the reasons discussed above, we are able to reach a determination on the merits of the prior art rejections before us in this appeal without resolving this issue, the Examiner and Appellant disagree on the proper construction of the term “commissural post” as used in claims 1 and 10. See Ans. 2; Reply Br. 2–4. Neither Appellant nor the Examiner directs our attention to evidence showing that “commissural post” is a recognized term of art as a component of a prosthetic valve support frame. We note that Nguyen indicates that “commissural posts” are an anatomic feature of the vessel wall in which the natural valve is located. See Nguyen ¶ 79. Specifically, Nguyen instructs that “[v]alve sinuses are dilations of the Appeal 2018-007690 Application 12/556,368 10 vessel wall that surround the natural valve leaflets” and allow for maximal opening of the leaflet at peak flow without the leaflet contacting the vessel wall. Id. Typically, each natural valve has a separate sinus bulge or cavity; for example, a two-leaflet valve is surrounded by two sinus bulges, a three- leaflet valve is surrounded by three sinus bulges, and a four-leaflet valve is surrounded by four sinus cavities. Id. “The individual sinus bulges or cavities are separated by vertical fibrous structures known as commissural posts,” which “define longitudinal structures with lesser outward curvature than the sinus cavities.” Id. Nguyen illustrates such commissural posts 11 and sinus cavities 12 in Figures 3A–3C. “[T]he commissural posts serve as the sites of attachment for the leaflets to the vessel wall (13).” Id. We look to the surrounding context of Appellant’s claims and Appellant’s Specification to determine the correlation, if any, between the anatomical “commissural posts” and the “commissural posts” of the support frame of Appellant’s prosthesis. It is clear from the context of claims 1 and 10 that a “commissural post” is a post of the support frame of the valve prosthesis that is attached to, or configured to be attached to, the prosthetic heart valve. Likewise, Appellant’s Specification discloses that support frame 140 is “shaped so as to define three commissural posts 134 to which prosthetic valve 118 is coupled.” Spec. 21:5–6. In this sense, the “commissural post” of Appellant’s prosthetic valve support frame is generally analogous to the natural anatomical “commissural post” of the vessel wall. Appellant contends that “the commissural posts cannot simply be any post” of the support frame, but, rather, are “the posts to which the commissures of the prosthetic valve are attached.” Reply Br. 4. Thus, Appeal 2018-007690 Application 12/556,368 11 according to Appellant, “if the prosthetic valve is not attached to a post, it cannot be a commissural post.” Id. For the reasons that follow, however, this is not a sufficient test to determine whether a particular portion of a unitary mesh-type support frame structure of the type disclosed by Appellant for use in supporting/securing a prosthetic valve is or is not a “commissural post” or part of a “commissural post.” In other words, the present application provides insufficient guidance to permit a person having ordinary skill in the art to distinguish, with reasonable precision, a “commissural post” from the remainder of the support structure, including, for example, an “axial support extension.” As Figure 6A is the only drawing figure in the present application that identifies angles of structures with respect to the central longitudinal axis, and the Specification does not specifically discuss such angles in connection with any other embodiments, we presume that claims 1 and 10 are drawn to this embodiment (i.e., valve prosthesis 130, illustrated in Figures 6A–6D, 7A–7D, and 8A–8C), and we focus our attention primarily on this embodiment in construing the claims. Accord Appeal Br. 2 (Summary of Claimed Subject Matter, referencing Figs. 6A–6D, 8C). Appellant’s Specification discloses valve prosthesis 130 comprising support frame 140, which defines three commissural posts 134, upstream skirt 131, and downstream axial support extensions 128. Spec. 21: 4–7, 17– 18. According to the Specification, downstream axial support extensions 128 “join a downstream side of upstream skirt 131, and extend in a downstream direction at an angle ø with respect to central longitudinal axis 116 of valve prosthesis 130, while commissural posts 134 extend in a downstream direction at an angle α with respect to axis 116.” Id. at 21:18– Appeal 2018-007690 Application 12/556,368 12 25 (noting that “the angles are shown in Fig. 6A”). “Angle ø is greater than angle α,” and, thus, “downstream axial support extensions 128: (a) apply an upstream axial force to a downstream side of the native leaflet tips, (b) do not touch the leaflets of the prosthetic valve when the prosthetic valve is in its open position, and (c) provide stability of support frame 140.” Id. at 21:25–31. Figure 6A, cited by the Specification as purportedly showing angles ø and α, appears to identify two angles, one of which looks like “θ” and the other of which looks like “α,” relative to central longitudinal axis 116. However, Figure 6A does not include a reference numeral “128” to identify the downstream axial support extensions. The angle “θ” in Figure 6A appears to be the angle between central axis 116 and some structure identified as element “133.” We presume that the element labeled “133” is what the Specification refers to as “downstream axial support element 128” and that angle “θ” in Figure 6A and angle “ø” in the Specification denote the radially outward angle defined by downstream support element 128 with respect to central longitudinal axis 116. Angle “α” appears to be the angle between commissural post 134 and central axis 116. Appellant’s Figures 6B–6D are of very poor quality and include reference numerals that are either illegible or barely legible. Figures 6B–6D appear to identify elements 128 of support frame 140 forming the bottoms of six primary cells joined at five junctions, with commissural posts located at three of these five junctions. Although not labeled in Figure 6A, and labeled with an illegibly small font in Figures 6B and 6C, upper sinus support elements 136 appear to form the tops of these primary cells. See Figs. 6B, 6C; Spec. 22:25–23:4. The Specification Appeal 2018-007690 Application 12/556,368 13 describes axial extensions 128 joining upper sinus support elements 136 at the junctions between the primary cells without a commissural post and describes the upstream ends of the remainder of upper sinus elements 136 joining the downstream ends of commissural posts 134. Id. at 22:27–30; Fig. 6C. Further, according to the Specification, “[f]or some applications, an upstream-most portion of each downstream axial support extension 128 joins the downstream site of upstream skirt 131, and two lateral portions of each extension join respective cells of the frame that extend in an upstream direction from respective commissural posts 134.” Id. at 22:3–8. Figures 6B and 6C appear to best illustrate the cells extending in an upstream direction from commissural posts 134. Of all of the drawings illustrating valve prosthesis 130, Figure 8C depicts commissural posts 134 most clearly. Aside from what appears to be some sort of thread or suture wrapped helically around them, commissural posts 134 appear structurally indistinguishable from downstream axial support extensions 128, as illustrated in Figure 8C. Although, likely for clarity, Figure 8C shows only a portion of valve support frame 140, and omits prosthetic valve 118, we speculate that this thread or suture may be intended to represent attachment of commissural posts to the prosthetic valve. By contrast, other drawings in the present application, such as, for example, Figures 1A, 1B, and 5A–5C, illustrating other embodiments of valve prostheses, depict commissural posts 34 comprising widened plate-like sections having axially extending slots and suture bores, much like the distal ends of support posts 22 in Figures 6C and 8 of Nguyen. Given the structural similarity between element 134, which Appellant identifies as a “commissural post,” and other portions of support frame 140, Appeal 2018-007690 Application 12/556,368 14 such as axial support extensions 128, it is unclear how a person having ordinary skill in the art would be able to distinguish a “commissural post,” as set forth in claim 10, from the remainder of the support frame, including “axial support extensions.” We appreciate that claim 10 recites that “the commissural posts are arranged about a central longitudinal axis of the support frame and are configured to have a prosthetic valve attached thereto.” Appeal Br. 25 (Claims App.). However, claim 10 does not positively recite a prosthetic valve, much less that the commissural posts are attached thereto. Axial support extensions 128 are arranged about a central longitudinal axis of the support frame and appear similarly amenable to having a prosthetic valve attached thereto, such as by stitching to a valve commissural tab, as evidenced by Nguyen. See, e.g., Nguyen, Figs. 11, 12 (commissural tab 35); ¶ 103 (teaching that commissural tabs 35 of prosthetic valve 32 can be stitched directly to hexagon shaped elements 50). Thus, a person having ordinary skill in the art would not be reasonably apprised of the scope of the term “commissural post” or “axial support extension” as used in claim 10, so as to be able to distinguish them from one another or from the remainder of the support frame and to ascertain whether a particular support frame satisfies the angle requirements set forth in claim 1. Likewise, although claim 1 positively recites a prosthetic heart valve attached to the commissural posts, given the aforementioned lack of guidance in the Specification or drawings for distinguishing between a “commissural post” and the remainder of the support frame, including an “axial support extension,” a person having ordinary skill in the would not be reasonably apprised of the scope of the term “commissural post.” For example, a skilled artisan may be able to determine, readily and with Appeal 2018-007690 Application 12/556,368 15 reasonable certainty, that portions of a support frame of a valve prosthesis in direct contact with a commissural tab of a prosthetic valve, or in direct contact with stitches attaching the support frame to a prosthetic valve, are part of a “commissural post.” However, it is unclear how one would determine, with reasonable certainty, where the “commissural post” ends, and the remainder of the support frame (e.g., axial support extensions) begin, especially for a unitary mesh-like support frame comprising a plurality of spaghetti-like segments that diverge away from and converge toward other segments so as to form cells, such as support frame 140 disclosed by Appellant. Merely by way of example, because both the two lateral portions of each axial support extension 128 joining respective cells that extend in an upstream direction from respective commissural posts 134, and the frame segments forming these respective cells (see Spec. 22:3–8), transition into commissural posts 134, as illustrated in Figure 6B, an artisan would not be able to determine, with reasonable certainty, where commissural posts 134 end and the lateral portions of axial support extension 128 and upstream frame segments begin. Indeed, some artisans, such as Nguyen, might wonder why Appellant characterizes the two lateral portions as being part of the extension, rather than part of the commissural post, and might interpret the respective cells that extend upstream from the commissural posts, to be part of the “commissural posts.” See, e.g., Nguyen, Fig. 13; ¶¶ 104–105 (describing three posts 52, each comprising distal end 54 for attachment to commissural tabs 35 of the prosthetic valve and diamond-shaped elements 55, extending from the proximal end to the distal end of the valve and providing cantilevered support to tabs 35). Similarly, one artisan, if Appeal 2018-007690 Application 12/556,368 16 asked to identify the “commissural posts” in the embodiment of Nguyen’s Figures 11 and 12, consistent with Appellant’s Specification and drawings, might include only the vertical/longitudinal members adjoining hexagon elements 50, while others might also include diamonds 49, or at least the top portions thereof, that contact tabs 35, under each of the vertical/longitudinal members as part of the “commissural posts.” Still others might include the entirety of each of the adjoining hexagon elements 50 to which commissural tabs 35 are stitched directly (Nguyen ¶ 103) as part of the “commissural post.” For the above reasons, when considered in light of the underlying disclosure of the present application, as viewed by one of ordinary skill in the art, the terms “commissural post” and “axial support extension” are vague, ambiguous, or indefinite terms. Thus, claims 1 and 10, and their dependent claims, when read in light of the Specification, do not reasonably apprise those skilled in the art of the scope of the invention, as required by the second paragraph of 35 U.S.C. § 112. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/ Basis Affirme d Reversed New Ground 1, 2, 5-16 102(b) Nguyen 1, 2, 5-16 3, 4, 17-20 103(a) Nguyen 3, 4, 17-20 112, 2nd paragraph 1-20 Overall Outcome 1-20 1-20 Appeal 2018-007690 Application 12/556,368 17 FINALITY OF DECISION This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides: When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. Appeal 2018-007690 Application 12/556,368 18 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). REVERSED; 37 C.F.R. § 41.50(b) Copy with citationCopy as parenthetical citation