EIT Emerging Implant Technologies GmbH

Patent Trials and Appeals BoardApr 1, 2021

2020004993 (P.T.A.B. Apr. 1, 2021)

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. 14/839,991 08/30/2015 Morgan Packard Lorio 104525.007643 5840 53443 7590 04/01/2021 BakerHostetler Cira Centre, 12th Floor 2929 Arch Street Philadelphia, PA 19104-2891 EXAMINER PLIONIS, NICHOLAS J ART UNIT PAPER NUMBER 3773 NOTIFICATION DATE DELIVERY MODE 04/01/2021 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): eofficemonitor@bakerlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MORGAN PACKARD LORIO Appeal 2020-004993 Application 14/839,991 Technology Center 3700 Before BRANDON J. WARNER, JAMES A. WORTH, and MICHAEL L. WOODS, Administrative Patent Judges. WOODS, 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 1–12, 17–19, and 21–25. See Appeal Br. 3. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies EIT Emerging Implant Technologies, GMBH, a Johnson & Johnson company, as the real party in interest. Appeal Br. 1. Appeal 2020-004993 Application 14/839,991 2 CLAIMED SUBJECT MATTER The application is titled “Expandable Intervertebral Cage with Living Hinges Apparatus, Systems and Methods of Manufacture Thereof” and relates in relevant part to “methods for manufacturing the expandable intervertebral cage using 3D printing methods.” Spec. ¶ 2; Response to Notification of Non-Compliant Appeal Brief (dated Mar. 23, 2020) (“Claims App.”) A2–A6. Independent claim 1 and dependent claim 6 are reproduced, below: 1. A method for making an expandable intervertebral cage with living hinges using 3D printable materials for placement between adjacent vertebrae, the method comprising: providing 3D data of the expandable intervertebral cage to a 3D printer, the expandable intervertebral cage including a circuitous body having a plurality of side segments rotatably attached by integral living hinges configured to plastically deform during a transition of the circuitous body from an unexpanded configuration to an expanded configuration about the living hinges and maintain the expanded configuration subsequent to the transition; and printing the plurality of side segments and integral living hinges of the circuitous body using one or more 3D printable materials. 6. The method of claim 1, wherein the integral living hinges comprise a relatively flexible 3D printable material and the side segments comprise a relatively rigid 3D printable material. Claims App. A2–A3. Appeal 2020-004993 Application 14/839,991 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Lowery US 2007/0161993 A1 July 12, 2007 Jimenez US 2010/0185291 A1 July 22, 2010 Mather US 2011/0301710 A1 Dec. 8, 2011 Purcell US 2012/0083887 A1 Apr. 5, 2012 Jones US 2013/0338776 A1 Dec. 19, 2013 Padovani US 2015/0328005 A1 Nov. 19, 2015 REJECTIONS The following rejections are before us on appeal: Claims Rejected 35 U.S.C. § Reference(s)/Basis 1, 5, 9, 11, 12, 17, 18, 21, 22 103 Purcell, Jimenez, Padovani 2–4, 10, 19, 25 103 Purcell, Jimenez, Padovani, Mather 6, 7, 23, 24 103 Purcell, Jimenez, Padovani, Lowery, Mather 8 103 Purcell, Jimenez, Padovani, Jones Final Act. 2–13. OPINION 1. Rejection – Purcell, Jimenez, and Padovani The Examiner rejects claims 1, 5, 9, 11, 12, 17, 18, 21, and 22 as unpatentable over Purcell in view of Jimenez and Padovani. Final Act. 2. Appellant argues these claims as a group. See Appeal Br. 14–20. We select independent claim 1 as the representative claim, with claims 5, 9, 11, 12, 17, 18, 21, and 22 standing or falling with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2020-004993 Application 14/839,991 4 a. Examiner’s Rejection In rejecting claim 1, the Examiner finds that Purcell discloses a method for making an expandable intervertebral cage with living hinges, where the hinges allow the cage to move from a first, non-expanded configuration, to a second, expanded configuration. See Final Act. 2–3. We reproduce Purcell’s Figure 1, below: Appeal 2020-004993 Application 14/839,991 5 Figure 1 “is an isometric view of an embodiment of a minimally invasive intervertebral implant in a first,” or non-expanded, configuration. See Purcell ¶ 8. We also reproduce Purcell’s Figure 3, below: Figure 3 “is an isometric view of the minimally invasive intervertebral implant of FIG. 1 in a second,” expanded, configuration. See id. ¶¶ 12, 35. The Examiner finds that Purcell discloses a plurality of side segments 150 rotatably attached by integral living hinges 155, which are configured to plastically deform during a transition of the circuitous body from an unexpanded configuration 200 (Fig. 1) to an expanded configuration 300 (Fig. 3). See Final Act. 2–3 (citing Purcell ¶¶ 34, 35). The Examiner acknowledges, however, that “Purcell fails to disclose using 3D printable materials to make the expandable intervertebral cage.” Id. at 3. To address this limitation, the Examiner relies on Jimenez and finds that Jimenez teaches a method of making intervertebral cages that include deformable hinges using 3D printable materials. Id. (citing Jimenez ¶¶ 102, 104). In combining Purcell with Jimenez, the Examiner reasons: Appeal 2020-004993 Application 14/839,991 6 It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Purcell to make the expandable intervertebral cage from 3D printable materials in order to make the cage into a one-piece body as suggested by Jimenez in order to provide cost savings over devices assembled from multiple pieces, and because such a modification merely involves applying a known technique (3D printing of intervertebral implants) to a known implant (an expandable intervertebral implant disclosed by Purcell) ready for improvement to yield predictable results of an improved implant (an expandable intervertebral implant able to be made into one piece). Id. (citing Jimenez ¶ 106) (emphasis added). The Examiner further acknowledges that “Purcell in view of Jimenez fails to explicitly disclose providing 3D data of the expandable intervertebral cage to a 3D printer for printing parts of the cage . . . using one or more 3D printable materials.” Id. To address this perceived shortcoming, the Examiner relies on Padovani and finds that “Padovani discloses a method of making an intervertebral implant using 3D printable material . . . including using 3D printable materials.” Id. (citing Padovani ¶¶ 170, 171). In further combining Padovani to Purcell and Jimenez, the Examiner reasons: It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of making the implant of Purcell in view of Jimenez to provide 3D data of the expandable intervertebral cage to a 3D printer for printing parts of the cage (i.e., the plurality of side segments and integral living hinges of the circuitous body) as suggested by Padovani in order to provide the ability to shape the implant precisely to customize to a patient’s body. Additionally, such a modification merely involves applying a known technique (3D printing of intervertebral implants) to a known implant (an expandable intervertebral implant disclosed by Purcell) ready for improvement to yield predictable results of Appeal 2020-004993 Application 14/839,991 7 an improved implant (an expandable intervertebral implant able to be precisely customized for a given patient). Id. at 4 (citing Padovani ¶ 171) (emphasis added). b. Analysis In contesting the rejection, Appellant organizes its arguments into three groups. See Appeal Br. 14–20. For consistency and clarity of record, we address each of Appellant’s arguments as organized by Appellant. i. Jimenez fails to teach or suggest 3D printable materials to make the expandable intervertebral cage of Purcell First, Appellant argues that “the Examiner has failed to cite to any teaching in Jimenez that the deformable hinges 112 are, in fact, plastically deformable.” Appeal Br. 16. Appellant explains that, as a result, a skilled artisan would not have combined Purcell, which discloses plastically deformable hinges, with Jimenez’s elastically deformable flexure members (or “hinges”) to arrive at the claimed invention. See id. (“[T]o the extent that one having ordinary skill in the art would combine the teachings of Jimenez as a whole into Purcell, the resulting implant would include elastically deformable hinges.”). Appellant also argues that the Examiner’s cited portion of Jimenez “does not state that the entire device is 3D printed” and that the “Examiner has failed to cite to any teaching in Jimenez that the one-piece body (and thus the flexure members) is manufactured using three-dimensional printing techniques.” Id. at 17; see also Reply Br. 2 (“Jimenez does not teach one Appeal 2020-004993 Application 14/839,991 8 having ordinary skill in the art to 3D print, or how to print, plastically deformable living hinges of an intervertebral cage.”). Appellant’s arguments are not persuasive. As to Appellant’s contention that Jimenez’s flexure members are not plastically deformable, and thus not “living hinges” (id. at 16), Appellant cannot show nonobviousness by attacking references individually. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references.”)); see also Ans. 15 (explaining the same). The Examiner does not rely on Jimenez for teaching plastically deformable hinges. See Final Act. 3; see also Ans. 15. Rather, “Purcell is relied on for disclosing an intervertebral implant utilizing plastically deformable living hinges and Jimenez is relied on for suggesting making an expandable intervertebral implants via 3D printing.” Ans. 15. Turning to Appellant’s contention that “Jimenez does not teach one having ordinary skill in the art to 3D print, or how to print, plastically deformable living hinges of an intervertebral cage” (Reply Br. 2), we find this unpersuasive. Even if Jimenez may not explicitly disclose “plastically deformable” hinges, Jimenez discloses intervertebral body fusion devices with “flexures” that “deform differently from the ones on each end due to the asymmetry of the device.” Jimenez ¶ 102; see also id. ¶ 103 (“[F]lexures 1112 of device 1100 deform differently than the ones on each end due to the asymmetric sets of structural members. In this embodiment, the end plates 1108 are thicker and do not deform under the compressive load.”). Jimenez further discloses that “the device can be manufactured using three- Appeal 2020-004993 Application 14/839,991 9 dimensional printing techniques.” Id. ¶ 106. Based on these disclosures, we agree with the Examiner that Jimenez generally teaches utilizing 3D printing to manufacture intervertebral implants with flexible hinges. See Ans. 16 (“Paragraph [0106] of Jimenez states that ‘the device can be manufactured using three-dimensional printing techniques’. Antecedent basis for the term ‘the device’ is ‘distractable intervertebral device’, which is the entire intervertebral device, including flexure members.”). For the foregoing reasons, Appellant’s first group of arguments is not persuasive. ii. The combination of Purcell in view of Jimenez, and further in view of Padovani, fails to teach or suggest each limitation of claims 1, 18, and 21 Appellant further contends that “the Examiner’s reliance on Padovani is misplaced” and that “Padovani fails to disclose an expandable intervertebral cage.” Appeal Br. 18. Appellant explains, “as discussed above with respect to Jimenez, the ‘hinges’ of Padovani are both structurally and functionally different than the hinges disclosed in Purcell.” Id. Appellant further explains, “Padovani fails to teach one having ordinary skill in the art how to 3D print an implant different than the one disclosed in Padovani, particularly an implant having plastically deformable living hinges as taught in Purcell.” Reply Br. 4. Appellant asserts, “it is Appellant’s patent application that discloses how to 3D print an implant having plastically deformable living hinges.” Id. (citing Spec. ¶¶ 63–65). Appellant’s second argument is not persuasive. We acknowledge that the “living hinges” disclosed in Purcell are not identical to the “flexures” disclosed in Jimenez (see, e.g., Jimenez ¶¶ 102, Appeal 2020-004993 Application 14/839,991 10 104) or the “spring features” disclosed in Padovani (see, e.g., Padovani ¶ 159). Nevertheless, and as with Appellant’s arguments attacking Jimenez, Appellant’s arguments attacking Padovani are equally unpersuasive as the rejection is based on a combination of references, and one cannot show nonobviousness by attacking Padovani individually. See Merck, 800 F.2d at 1097. Importantly, the Examiner relies on Purcell, not Padovani, for disclosing plastically deformable hinges (see Final Act. 2–4; see also Ans. 16), and Appellant’s argument does not identify error in the Examiner’s findings with respect to either reference. Moreover, Appellant’s contention that “Padovani fails to teach one having ordinary skill in the art how to 3D print an implant different than the one disclosed in Padovani, particularly an implant having plastically deformable living hinges as taught in Purcell” is also unpersuasive. Reply Br. 4. Padovani discloses spacers (intervertebral implants) that include spring features to allow for compression and/or expansion of the implant. Padovani ¶ 159. Padovani further discloses that “[i]n manufacturing the above described implants, 3D printing and/or rapid manufacturing techniques may be used.” Id. ¶ 170. Padovani further discloses that “the implant may be configured from one type of material or a combination of different materials” (id.) and that “[t]he use of 3D printing provides the ability to shape each implant precisely to customize to the patient’s body” (id. ¶ 171). Based on these disclosures, we agree with the Examiner that Padovani teaches 3D printing of intervertebral implants with deformable features, including “living hinges,” which may be made from a different material, and manufactured based on a patient’s particular needs. See Final Act. 4; see also Ans. 16. Appeal 2020-004993 Application 14/839,991 11 Regarding’s Appellant’s position that “it is Appellant’s patent application that discloses how to 3D print an implant having plastically deformable living hinges,” rather than the teachings of the cited art, we disagree. Reply Br. 4 (citing Spec. ¶¶ 63–65). Appellant references three paragraphs of its Specification (id.), which we reproduce, below: [0063] One feature using a 3D printing process is the recognition that the expandable intervertebral cage does not have to be limited to the traditional manufacturing constraints such as those imposed by conventional machining or casting methods. The 3D printing process of the expandable intervertebral cage can use various materials including thermoplastics, photopolymers, metal powders, eutectic metals, titanium alloys and other materials. [0064] The 3D printing process of the expandable intervertebral cage can use various materials including thermoplastics, photopolymers, metal powders, eutectic metals, titanium alloys and other materials. Because the expandable intervertebral cage will be implanted in the body, the preferred material is a biocompatible material, for example, a natural biocompatible material, a synthetic biocompatible material, a metallic biocompatible material, adaptive material, and/or any other desired biocompatible material. The implant can be made of polyetherketone (PEK), polyetherimide (PEI), such as Ultem, ultrahigh molecular weight polyethylene (UHMPE), polyphenylene, polyether-ether-ketone (PEEK), comprise a memory PEEK material such as, for example, PEEK Altera, or any other desired biocompatible material. The 3D printing process may also include hybrid material designs, i.e. PEEK & Titanium. [0065] In some embodiments the expandable intervertebral cage may be manufactured using a 3D printing process with a metal material having a relatively high density deposited within a polymer substrate having a relatively low density. In some embodiments the expandable intervertebral cage may be manufactured with the side segments made from a Appeal 2020-004993 Application 14/839,991 12 relatively rigid 3D printable material and the integral living hinges made from a relatively flexible 3D printable material. Other combinations may include any combination of metal, polymer, ceramic, or composites for the side segments and integral living hinge. In some embodiments the expandable intervertebral cage may be manufactured using a combination of traditional manufacturing processes and 3D printing processes. Spec. ¶¶ 63–65 (emphases added). Nothing in the above-three paragraphs, however, describes overcoming any technical challenge in utilizing 3D printing to manufacture intervertebral implants with “living hinges.” See Ans. 17 (finding the same). These paragraphs broadly disclose the universe of materials in its description that “any combination of metal, polymer, ceramic, or composites for the side segments and integral living hinge” (id. ¶ 65), “including thermoplastics, photopolymers, metal powders, eutectic metals, titanium alloys and other materials” (id. ¶ 63 (emphasis added)) may be used. We agree with the Examiner’s assessment that “[t]hese paragraphs of Applicant’s specification merely teach that the 3D printing process allows the use of various materials to make the intervertebral cage.” Ans. 17. We further reproduce Figure 3 of Appellant’s Specification, below: Appeal 2020-004993 Application 14/839,991 13 “Figure 3 is a flowchart of a 3D model printing method.” Spec. ¶ 32. We do not find this figure or its accompanying description as addressing any technical challenges relating to 3D-printing implants with “living hinges,” either. For the foregoing reasons, Appellant’s second group of arguments is not persuasive. Appeal 2020-004993 Application 14/839,991 14 iii. The rejections of independent claims 1, 18, and 21 are necessarily based on impermissible hindsight in light of Appellant’s claimed invention Appellant further submits that the “combination of Purcell, Jimenez, and Padovani is based on improper hindsight giving the benefits of Appellant’s invention.” Appeal Br. 19. Appellant acknowledges that, although “there is no requirement for an express, written motivation to combine to appear in the prior-art references,” the Examiner has failed to identify “any teaching or suggestion in the prior art that would cause” a skilled artisan “to modify the teachings of Purcell based on the teachings of Jimenez and Padovani to produce an expandable intervertebral cage having an integral living hinge that is plastically deformable to maintain the cage in its expanded configuration.” Id. Appellant explains that “the Examiner has failed to provide any suitable motivation to combine.” Id. at 20. We disagree with Appellant. In combining Purcell with Jimenez, the Examiner reasons that a skilled artisan would have made Purcell’s implant utilizing 3D manufacturing “in order to make the cage into a one-piece body as suggested by Jimenez” for cost-saving purposes. Final Act. 3. Jimenez explicitly teaches the use of 3D manufacturing and that making the device a one-piece device “provides great cost savings over devices that require multiple pieces.” Jimenez ¶ 106. As such, the Examiner’s reasoning for 3D printing Purcell’s implant is explicitly taught by Jimenez, not based on impermissible hindsight. In further combining the cited art with Padovani, the Examiner reasons that a skilled artisan would have Appeal 2020-004993 Application 14/839,991 15 modif[ied] the method of making the implant of Purcell in view of Jimenez to provide 3D data of the expandable intervertebral cage to a 3D printer for printing parts of the cage (i.e., the plurality of side segments and integral living hinges of the circuitous body) as suggested by Padovani in order to provide the ability to shape the implant precisely to customize a patient’s body. Ans. 4. Padovani explicitly discloses an implant with spring features that can be manufactured with 3D printing, made from one or a combination of materials. Padovani ¶¶ 159, 170. Padovani further discloses that the use of 3D printing allows the “shape [of] each implant [to be] precisely [] customize[d] to the patient’s body.” Id. ¶ 171. Rather than relying on impermissible hindsight, the Examiner’s reason for further combining Padovani with the cited art is based on the express teachings of Padovani. Accordingly, Appellant’s third argument is not persuasive. c. Summary of Rejection Based on Purcell, Jimenez, and Padovani In summary, Appellant’s arguments do not persuade us of Examiner error in the rejection of independent claim 1. As such, we affirm the rejection of claim 1, along with claims 5, 9, 11, 12, 17, 18, 21, and 22, which fall therewith (see 37 C.F.R. § 41.37(c)(1)(iv)), as unpatentable over Purcell in view of Jimenez and Padovani. 2. Rejection – Purcell, Jimenez, Padovani, and Mather The Examiner rejects claims 2–4, 10, 19, and 24 as unpatentable over Purcell in view of Jimenez, Padovani, and Mather. Final Act. 10. Appeal 2020-004993 Application 14/839,991 16 Appellant does not present additional arguments contesting the rejection of these claims. See Appeal Br. 14–21. Accordingly, Appellant does not persuade us of Examiner error in the rejection of claims 2–4, 10, 19, and 24 as unpatentable over Purcell in view of Jimenez, Padovani, and Mather. 3. Rejection – Purcell, Jimenez, Padovani, Lowery, and Mather The Examiner rejects claims 6, 7, 23, and 24 as unpatentable over Purcell in view of Jimenez, Padovani, Lowery, and Mather. Final Act. 11. Appellant presents separate arguments for claims 6 and 23. See Appeal Br. 20. Appellant does not present additional arguments contesting the rejection of claims 7 and 24. See id. In rejecting claims 6 and 23, the Examiner finds that “Purcell in view of Jimenez and Padovani fails to suggest wherein the integral living hinges comprises a relatively flexible 3D printable material and the side segments comprise a relatively rigid 3D printable material.” Final Act. 12. The Examiner relies on Lowery and Mather for addressing the limitation. See id. The Examiner finds that “Lowery discloses a vertebral implant wherein flexible portions of the implant are made from a non-metallic material and the rigid portions of the implant are made from a metallic material.” Id. (citing Lowery ¶ 87). In combining Lowery with the other cited art, the Examiner reasons that a skilled artisan would have made “the rigid side segments of Purcell from a metallic material and the flexible hinges of Purcell from a non-metallic material . . . to select a known material on the basis of its suitability for the intended use.” Id. (citing In re Leshin, 277 F.2d 197 (CCPA 1960)). The Examiner further cites to Mather for Appeal 2020-004993 Application 14/839,991 17 “suggest[ing] that synthetic biocompatible metals and polymers for making rigid and flexible components of an intervertebral implant are suitable for making an intervertebral implant via 3D printing.” Id. (citing Mather ¶ 71). In contesting the rejection of claims 6 and 23, Appellant argues that “Lowery fails to disclose that the implant can be 3D printed” and that Mather fails to teach or suggest “the step of printing rigid and flexible components using non-metallic materials and rigid materials.” Appeal Br. 21; see also Reply Br. 5 (“Lowery does not disclose 3D printing”), 6 (“Mather merely teaches a number of methods for producing an implant using a number of materials.”). As discussed above, one cannot show nonobviousness by attacking references individually. See Merck, 800 F.2d at 1097. The Examiner does not rely on Lowery for teaching 3D printing; rather, “Lowery is relied on for suggesting using non-metallic materials for flexible portions of the implant, and metallic materials for rigid portions.” Ans. 20. Mather, on the other hand, “is relied on only for suggesting that [the] biocompatible metals and polymers are suitable for 3D printing implants.” Id. Appellant’s arguments do not identify error in the Examiner’s findings as to Lowery or Mather, and the Examiner’s reasons for further modifying Purcell by 3D printing the “living hinges” from a flexible non-metallic material and the other rigid portions of the implant from metal is supported by the teachings of Lowery and Mather. Accordingly, Appellant does not persuade us of Examiner error in the rejection of claims 6 and 23, or of claims 7 and 24—which were not separately argued—as unpatentable over Purcell in view of Jimenez, Padovani, Lowery, and Mather. Appeal 2020-004993 Application 14/839,991 18 4. Rejection – Purcell, Jimenez, Padovani, and Jones The Examiner rejects claim 8 as unpatentable over Purcell in view of Jimenez, Padovani, and Jones. Final Act. 12. Appellant does not present additional arguments contesting the rejection of claim 8. See Appeal Br. 14–21. Accordingly, Appellant does not persuade us of Examiner error in the rejection of claim 8 as unpatentable over Purcell in view of Jimenez, Padovani, and Jones. CONCLUSION We affirm the rejections of claims 1–12, 17–19, and 21–25 as unpatentable. Appeal 2020-004993 Application 14/839,991 19 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 5, 9, 11, 12, 17, 18, 21, 22 103 Purcell, Jimenez, Padovani 1, 5, 9, 11, 12, 17, 18, 21, 22 2–4, 10, 19, 25 103 Purcell, Jimenez, Padovani, Mather 2–4, 10, 19, 25 6, 7, 23, 24 103 Purcell, Jimenez, Padovani, Lowery, Mather 6, 7, 23, 24 8 103 Purcell, Jimenez, Padovani, Jones 8 Overall Outcome 1–12, 17–19, 21–25 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). AFFIRMED