2020003881 (P.T.A.B. Mar. 24, 2021)

FIBROTX OÜ

Patent Trials and Appeals BoardMar 24, 2021

2020003881 (P.T.A.B. Mar. 24, 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. 14/655,850 06/26/2015 Toomas Neuman 10342/004230-US0 6238 76808 7590 03/24/2021 Leason Ellis LLP One Barker Avenue Fifth Floor White Plains, NY 10601-1526 EXAMINER PORTILLO, JAIRO H ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 03/24/2021 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): uspto@leasonellis.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte TOOMAS NEUMAN and ARAM KAZARJAN ____________________ Appeal 2020-003881 Application 14/655,850 Technology Center 3700 ____________________ Before PHILLIP J. KAUFFMAN, ANNETTE R. REIMERS, and TARA L. HUTCHINGS, Administrative Patent Judges. KAUFFMAN, Administrative Patent Judge. DECISION ON APPEAL Appeal 2020-003881 Application 14/655,850 2 STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–9 and 11–20. Final Act. 2–17. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. CLAIMED SUBJECT MATTER The claimed invention relates to dermal patches for selectively retaining one or more analytes (substances being analyzed, especially for chemical analysis).2 Spec. 1:5–7. The independent claims recite: a dermal patch (claim 1), a method of measuring the concentration of one or more analytes using the dermal patch (claim 13), and a kit (including at least two dermal patches) for determining the effect of a topical treatment (claim 16). Id.; Appeal Br. 2, Claims App’x. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as FIBROTX OUE. Appeal Br. 2. 2 “Analyte,” TABER’S CYCLOPEDIC MEDICAL DICTIONARY (D. Venes, editor, F.A. Davis Co., Philadelphia, 20th edition 2005). Appeal 2020-003881 Application 14/655,850 3 1. A dermal patch comprising: a membrane layer (101, 601) for retaining one or more analyte(s) from a body of a subject, the membrane layer (101, 601) having a first and a second side, wherein the first side is in fluid communication with the skin of the subject, wherein the membrane layer (101, 601) has an area and is non-expandable; an adhesive layer (104); a backing layer (606); wherein an expandable layer (103, 603) is between the backing layer (606) and the membrane layer (101) wherein the membrane layer (101, 601) comprises one or more distinct capture section(s) with affinity molecules for selectively retaining one or more analyte(s). Appeal Br. 15 (Claims Appendix). REJECTIONS I. Claims 1, 6, 7, 12, 17, and 18 are rejected under 35 U.S.C. § 103(a) as unpatentable over Yum,3 Wenckens,4 Nagasuna,5 and Hogan.6 Final Act. 2– 5. II. Claim 2 is rejected under 35 U.S.C. § 103(a) as unpatentable over Yum, Wenckens, Nagasuna, and Schoendorfer.7 Final Act. 5. III. Claims 3–5 are rejected under 35 U.S.C. § 103(a) as unpatentable over Yum, Wenckens, Nagasuna, and Hymes.8 Final Act. 6–7. 3 Yum (US 6,251,083 B1, issued June 26, 2001). 4 Wenckens (US 2010/0297205 A1, published Nov. 25, 2010). 5 Nagasuna (US 2004/0019342 A1, published Jan. 29, 2004). 6 Hogan (US 2010/0209957 A1, published Aug. 19, 2010). 7 Schoendorfer (US 5,817,012, issued Oct. 6, 1998). 8 Hymes (US 6,455,065 B1, issued Sept. 24, 2002). Appeal 2020-003881 Application 14/655,850 4 IV. Claim 8 is rejected under 35 U.S.C. § 103(a) as unpatentable over Yum, Wenckens, Nagasuna, and Linder.9 Final Act. 7–8. V. Claim 9 is rejected under 35 U.S.C. § 103(a) as unpatentable over Yum, Wenckens, Nagasuna, and Peyser.10 Final Act. 8–9. VI. Claims 11, 13, 19, and 20 are rejected under 35 U.S.C. § 103(a) as unpatentable over Yum, Wenckens, Nagasuna, and Phan.11 Final Act. 9–13. VII. Claim 14 is rejected under 35 U.S.C. § 103(a) as unpatentable over Yum, Wenckens, Nagasuna, Phan, Fissell,12 and Stirbl.13 Final Act. 13–14. VIII. Claim 15 is rejected under 35 U.S.C. § 103(a) as unpatentable over Yum, Wenckens, Nagasuna, Phan, and Blaschuk.14 Final Act. 14–15. IX. Claim 16 is rejected under 35 U.S.C. § 103(a) as unpatentable over Yum, Wenckens, Nagasuna, Hymes, Turner,15 and Sloan.16 Final Act. 15– 17. 9 Linder (US 2006/0210616 A1, published Sept. 21, 2006). 10 Peyser (US 2007/0027383 A1, published Feb. 1, 2007). 11 Phan (US 2005/0106713 A1, published May 19, 2005). 12 Fissell (US 2009/0131858 A1, published May 21, 2009). 13 Stirbl (US 5,507,291, issued Apr. 16, 1996). 14 Blaschuk (US 2005/0129676 A1, published June 16, 2005). 15 Turner (US 5,462,743, issued Oct. 31, 1995). 16 Sloan (US 2007/0106135 A1, published May 10, 2007). Appeal 2020-003881 Application 14/655,850 5 ANALYSIS Rejection I Overview The Examiner concludes that the subject matter of claims 1, 6, 7, 12, 17, and 18 would have been obvious from the combined teachings of Yum, Wenckens, Nagasuna, and Hogan. Final Act. 2–5; Ans. 3–5. Appellant makes a variety of arguments against the rejection of independent claim 1. Appeal Br. 4–12; Reply Br. 3–6. For the reasons that follow, we sustain this rejection because Appellant’s arguments regarding claim 1 are not persuasive of error by the Examiner. See Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential); 37 C.F.R. § 41.37(c)(1)(iv) (We review the appealed rejections for error identified by Appellant, and arguments not made are forfeited.). Examiner’s Findings The Examiner determined that Yum discloses a dermal patch as claimed except: (1) the membrane layer being non-expandable, and (2) the expandable layer positioned between the backing and membrane layer. Final Act. 2–3. The Examiner relies on Nagasuna17 for a membrane layer being a non-expendable material, and relies on Wenckens as disclosing an expandable layer positioned as claimed. Id. at 3–4. 17 The Examiner relies on Hogan as evidence that nitrocellulose, as disclosed in Nagasuna, is a non-expandable material. Final Act. 3 (citing Hogan ¶ 76). Appeal 2020-003881 Application 14/655,850 6 Analysis Appellant argues that Yum’s adhesive layer (adhesive layer 21) holds the patch together, while the claimed adhesive layer secures the patch to the skin.18 Appeal Br. 7.19 We agree with the Examiner that claim 1 requires that the dermal patch includes an adhesive layer, but claim 1 does not require that the adhesive layer secures the patch to the skin. See Appeal Br. 15, Claims App’x; see also Ans. 3. Consequently, Appellant’s argument is not persuasive because it is not commensurate in scope with claim 1. Appellant argues that Yum’s mask 3 is not a backing layer as claimed, because it covers the membrane layer (porous matrix member 5), while claim 1 requires that the backing layer covers the adhesive layer. Appeal Br. 7–8; Final Act. 2. The premise of Appellant’s argument is that claim 1 requires the backing layer (mask 3) to cover the adhesive layer (adhesive layer 21). Claim 1 requires that the dermal patch include a backing layer positioned so that the expandable layer is between the backing layer and the membrane layer. See Appeal Br. 15, Claims App’x. We agree with the Examiner that claim 1 does not specify the positional relationship between 18 Parentheticals are to the prior art’s nomenclature. 19 In the Reply Brief, Appellant argues that Yum’s adhesive layer 6 is not an adhesive layer as claimed, but such argument is inapposite because the Examiner relies on Yum’s adhesive layer 21. See Reply Br. 3; Final Act. 2– 3. Appeal 2020-003881 Application 14/655,850 7 the backing layer and the adhesive layer. See Ans. 3–4. Consequently, Appellant’s argument is not persuasive because it is not commensurate in scope with claim 1. Appellant argues that the Examiner’s proposed modification to replace Yum’s membrane layer (matrix member 5) with Wenckens’s expandable layer (swell layer 3) would not provide a structure having an expandable layer that provides pressure against the membrane in the direction of the skin. Appeal Br. 8. In response, the Examiner clarifies that the proposed modification is to add Wenckens’s expandable layer (swell layer 3) to Yum’s patch without replacing any layers, such as Yum’s membrane layer (matrix member 5). Ans. 5; see also Reply Br. 3–4 (acknowledging the clarification). According to the Examiner, adding Wenckens’s expandable layer (swell layer 3) above Yum’s membrane layer (matrix member 5) would not necessitate changing the order of other layers. Ans. 5. Further, the Examiner finds that Wenckens’s expandable layer (swell layer 3) would apply pressure towards the membrane layer because swelling occurs in every direction. Id. (citing Wenckens’s Fig. 1). In response to the Examiner’s findings in the Answer, Appellant argues that a person of ordinary skill would not add Wenckens’s expandable layer (swell layer 3) to Yum’s patch because it would not function as a dermal patch as recited in claim 1. See Reply Br. 4. Specifically, according to Appellant, Yum’s patch does not include resistance in the structure to Appeal 2020-003881 Application 14/655,850 8 prevent swelling so that the expandable layer would swell in various directions, and as a consequence, it would provide no or insignificant pressure towards the skin. Id. Appellant does not cite to Yum or Wenckens in support of this argument. See id. Yum discloses a patch “for testing a body for the presence or concentration of an analyte.” Yum 4:17–19. The “patch is firmly applied to the patient[ʼ]s skin[,] opening tiny micro pores in the skin.” Yum 16:12–15. Patch 1 includes a membrane layer (matrix member 5), which absorbs bodily fluid from the patient’s skin and wicks the fluid toward a test side for chemical analysis. Yum 12:14–20, Fig. 3. Therefore, contrary to Appellant’s argument, Yum’s patch, like the claimed dermal patch, selectively retains analytes. Wenckens discloses that when liquid is added to the expandable layer (swell layer 3) while the patch is adhered to the patient’s skin, the expandable layer provides a light downward pressure. Wenckens ¶ 38. In light of these disclosures, we agree with the Examiner that it would have been obvious to add Wenckens’s expandable layer (swell layer 3) to Yum’s patch “to apply a pressure to a membrane layer [to facilitate] transfer of fluids from the skin.” Final Act. 3. In the Reply Brief, Appellant makes an argument with regard to dependent claims 3–5. Reply Br. 5. This argument was not made in the Appeal Brief, and is not responsive to an argument raised in the Examiner’s Answer. Further, Appellant does not attempt to show good cause why this Appeal 2020-003881 Application 14/655,850 9 argument was not raised earlier. Consequently, we do not consider this argument. See 37 C.F.R. § 41.41(b)(2). Appellant argues that Nagasuna’s membrane layer (liquid acquiring member formed of nitrocellulose) is completely different from the claimed non-expandable membrane layer. Appeal Br. 9. Appellant makes four assertions in support of this argument, and we address them in turn below. The first assertion is that Nagasuna is silent regarding the liquid acquiring member having first and second sides. Appeal Br. 9. The Examiner finds, and we agree, that Nagasuna’s liquid acquiring member may be sheet shaped, and as such, would have a first side and a second side. Ans. 4–5; Nagasuna ¶ 193; see also Ans. 5 (finding that Yum’s membrane layer may be cellulose fiber and citing Yum, 7:40–49). The second assertion is that paragraph 216 of Nagasuna does not teach or suggest why the liquid acquiring member would equate to a non- expandable membrane. Appeal Br. 9. This assertion is not responsive to the rejection as articulated by the Examiner. As explained above, the Examiner relies on Hogan as evidence that nitrocellulose, as disclosed in Nagasuna, is a non-expandable material. Final Act. 3 (citing Hogan ¶ 76). The third assertion is that Nagasuna’s liquid acquiring member absorbs large amounts of liquid and is incompatible with a non-expandable membrane as claimed. Appeal Br. 9. The claimed membrane layer is not required to only absorb small amounts of liquid. From this perspective, Appellant’s argument is not commensurate in scope with claim 1. Further, Appeal 2020-003881 Application 14/655,850 10 Nagasuna’s disclosure of forming a liquid acquiring member from cellulose fibers such as nitrocellulose (see Nagasuna ¶ 195) is consistent with Yum’s disclosure that membrane 5 may be cellulose fiber (Yum 7:42–46). Ans. 5. In light of this, we agree with the Examiner that the proposed combination is well supported by the compatibility of the references. Appellant’s general assertion that the combination would not work is not supported by citation to any evidence, and does not effectively address the Examiner’s explanation. The fourth assertion is that Nagasuna does not teach or suggest acquiring and retaining analytes. Appeal Br. 9. This assertion is an individual attack on Nagasuna, while the rejection is based on a combination of the references (Yum and Nagasuna). See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (citing In re Keller, 642 F.2d 413, 425 (CCPA 1981)) (One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.). As explained regarding the previous contention, the combination is based on modifying Yum’s cellulose fiber membrane 5 to be formed of nitrocellulose as disclosed by Nagasuna. See Final Act. 2–4; Ans. 5. Further, as explained above, Yum discloses a patch that captures analytes. Yum, Abstract, 4:17– 19. Appellant’s assertion that Nagasuna does not teach or suggest acquiring and retaining analytes does not persuasively address the Examiner’s analysis. Appellant also asserts that “the liquid acquiring member of Nagasuna is in the form of fibers or nonwoven fabrics having a ‘bulky structure,’ Appeal 2020-003881 Application 14/655,850 11 which is not same as a membrane” and “there is no teaching or suggestion in Hogan or Nagasuna that a ‘bulky structure’ of nitrocellulose fibers is non- expandable.” Appeal Br. 9. Nagasuna teaches “synthetic fibers (e.g. nonwoven fabrics having a bulky structure)” and “cellulose fibers (e.g. celluloses, cellulose acetate, and nitrocellulose).” Nagasuna ¶ 195. Indeed, Appellant acknowledges that Nagasuna’s liquid acquiring member “is in the form of fibers or nonwoven fabrics having a ‘bulky structure.’” Appeal Br. 9 (emphasis added). Here, the Examiner relies on the “cellulose” fibers of Nagasuna, not the “synthetic” fibers of Nagasuna, i.e., the “nonwoven fabrics having a bulky structure.” See Final Act. 3; see also Ans. 5; Nagasuna ¶ 195. Additionally, the Examiner clarifies in the Answer that “Nagasuna is brought [in] to teach that a material known in the art (nitrocellulose) to be of use in the application of liquid acquiring, could be applied as the construction material for the membrane previously taught in Yum.” Ans.5 (emphasis added); see also id. (finding that “the configuration of the membrane” is taught in Yum). In other words, as Yum teaches a “membrane” and that “the membrane can be a cellulose fiber,” the Examiner looks to Nagasura for “teach[ing] that cellulose fibers for retaining liquids could be nitrocellulose, as [nitrocellulose] was a known material in use in the art of liquid retention.” Id. (citing Yum 7:40–49). The Examiner then looks to the teachings of Hogan to further modify the nitrocellulose membrane of Yum, Wenchens, and Nagasuna to be Appeal 2020-003881 Application 14/655,850 12 nonexpandable, as Hogan teaches that “nitrocellulose is known to be a nonexpandable material.” See Final Act. 3 (citing Hogan ¶ 76). Appellant does not direct us to any discussion in Nagasuna of the “nitrocellulose” fibers having a “bulky structure.” See Appeal Br. 9. Indeed, Nagasuna differentiates between “hydrophilic fibers, such as cellulose fibers (e.g. celluloses, cellulose acetate, and nitrocellulose)” and “synthetic fibers such as the nonwoven fabrics having a bulky structure.” Nagasuna ¶ 195. In other words, the “nitrocellulose” fibers and the “synthetic” fibers described in Nagasuna are two different examples of liquid acquiring members that can be used in Nagasuna’s invention, wherein the “synthetic” fibers, not the “nitrocellulose” fibers, are described as “nonwoven fabrics having a bulky structure.” Nagasuna ¶ 195 (emphasis added). Appellant’s assertions that Nagasuna’s “bulky structured” nonwoven fabrics are not the same as a membrane and there is no teaching or suggestion in Hogan or Nagasuna that a “bulky structure” of nitrocellulose fibers is non-expandable do not persuasively address the Examiner’s analysis. Conclusion As detailed above, none of Appellant’s arguments demonstrate error by the Examiner. We sustain the rejection of claims 1, 6, 7, 12, 17, and 18 under 35 U.S.C. § 103(a) as unpatentable over Yum, Wenckens, Nagasuna, and Hogan. Appeal 2020-003881 Application 14/655,850 13 Remaining Grounds of Rejection20 For each of the remaining grounds of rejection, Appellant contends that additional references cited by the Examiner fail to remedy deficiencies in the teachings of Yum, Wenckens, and Nagasuna. As discussed above, we are persuaded that no such deficiencies exist. Therefore, we sustain the remaining rejections. CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 6, 7, 12, 17, 18 103(a) Yum, Wenckens, Nagasuna, Hogan 1, 6, 7, 12, 17, 18 2 103(a) Yum, Wenckens, Nagasuna, Schoendorfer 2 3–5 103(a) Yum, Wenckens, Nagasuna, Hymes 3–5 8 103(a) Yum, Wenckens, Nagasuna, Linder 8 20 In reference to claim 16, Appellant asserts that the combined teachings of Yum, Wenckens, Nagasuna, Hymes, Turner, and Sloan “do[] not amount to the kit of claim 16 as the kit comprises ‘at least two patches according to claim 1.’” Appeal Br. 12. However, the Examiner finds that Yum “teaches the at least two the patches being part of a kit.” Final Act. 15 (citing Yum 15:26–31); see also Yum 15:27–28 “[i]ndividually foil wrapped patches 302”; id. at Fig. 8. Appellant does not apprise us of Examiner error. Appeal Br. 12. Appeal 2020-003881 Application 14/655,850 14 9 103(a) Yum, Wenckens, Nagasuna, Peyser 9 11, 13, 19, 20 103(a) Yum, Wenckens, Nagasuna, Phan 11, 13, 19, 20 14 103(a) Yum, Wenckens, Nagasuna, Phan, Fissell, Stirbl 14 15 103(a) Yum, Wenckens, Nagasuna, Phan, Blaschuk 15 16 103(a) Yum, Wenckens, Nagasuna, Hymes, Turner, Sloan 16 Overall Outcome 1–9, 11–20 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