AgaMatrix, Inc.

Patent Trials and Appeals BoardApr 14, 2021

2020001778 (P.T.A.B. Apr. 14, 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. 14/010,792 08/27/2013 Ian Harding AGAM.P-036-2 5578 57381 7590 04/14/2021 Larson & Anderson, LLC P.O. BOX 4928 DILLON, CO 80435 EXAMINER VAN, LUAN V ART UNIT PAPER NUMBER 1795 NOTIFICATION DATE DELIVERY MODE 04/14/2021 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): docket@himtnpatents.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte IAN HARDING ____________ Appeal 2020-001778 Application 14/010,792 Technology Center 1700 ____________ Before LINDA M. GAUDETTE, DONNA M. PRAISS, and MERRELL C. CASHION, JR., Administrative Patent Judges. CASHION, 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 finally rejecting claims 26–47. An oral hearing was held on April 5, 2021.2 We have jurisdiction under 35 U.S.C. § 6(a). We reverse and ENTER A NEW GROUND OF REJECTION pursuant to 37 C.F.R. § 41.50(b). 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies “Agamatrix, Inc.” as the real party in interest. Appeal Br. 1. 2 A written transcript of the oral hearing will be entered into the record when available. Appeal 2020-001778 Application 14/010,792 2 The invention “relates to electrochemical assay devices in the form of single use test strips for detecting the presence or amount of an analyte in a sample and to methods of making and using such devices.” Spec. ¶ 2. Claims 26 and 37, reproduced from the Claims Appendix to the Appeal Brief, illustrate the invention: 26. An electrochemical test device comprising a first substrate having a first electrode disposed thereon, a second substrate having a second electrode disposed thereon, and a spacer disposed between the first and second substrates and having an opening therein, whereby a sample-receiving space is defined that has a first surface having the first electrode disposed thereon, a second surface, opposite the first surface, having the second electrode disposed thereon, and side walls formed from edges of the opening in the spacer; and a reagent comprising a redox active material which is oxidized at the first electrode and reduced at the second electrode when the device is used; wherein in the test device prior to introduction of a liquid sample, the reagent is disposed in a dried layer, covering as a coating at least a portion of the first or second electrode and at least a portion of the side walls, said layer extending as a coating contiguously from the covered electrode and along the side walls. 37. A method of making an electrochemical test device comprising the steps of: (a) forming a first substrate having a first electrode disposed thereon; (b) forming a spacer layer on the first substrate, said spacer layer having an opening formed therein through which the first electrode is exposed and side walls within the opening; Appeal 2020-001778 Application 14/010,792 3 (c) introducing a liquid reagent comprising a redox active material into the opening in the spacer layer, (d) drying the liquid reagent to form a dried reagent, wherein the liquid reagent is introduced to the opening in such a manner that upon drying a dried reagent layer is formed contiguously covering at least a portion of the first electrode and at least a portion of the side walls; and (e) placing a second substrate having a second electrode disposed thereon on the spacer layer aligned to have the second electrode facing the first electrode, thereby forming a sample- receiving space that has a first surface having the first electrode disposed thereon, a second surface, opposite the first surface, having the second electrode disposed thereon, and side walls formed from edges of the opening in the spacer. Appellant requests review of the following rejections from the Examiner’s Final Office Action dated January 29, 2019: I. Claims 26–44, 46, and 47 rejected under pre-AIA 35 U.S.C. § 102(b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Hodges (US 6,878,251 B2, issued Apr. 12, 2005); and II. Claim 45 rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Hodges and Nankai (US 5,120,420, issued June 9, 1992). OPINION Device Claims 26–36 REJECTION UNDER 35 U.S.C. §§ 102 and 103 For reasons we give below, we determine that the subject matter of claims 26–36 is indefinite. Therefore, we are unable to determine the Appeal 2020-001778 Application 14/010,792 4 propriety of the prior art rejections of these claims. The review of the prior art rejections of claims 26–36 under 35 U.S.C. §§ 102 and 103 would require considerable speculation as to the scope of the claims. Such speculation would not be appropriate. See In re Steele, 305 F.2d 859, 862 (CCPA 1962). We, therefore, procedurally reverse the prior art rejections of claims 26–36 under 35 U.S.C. §§ 102 and 103. We emphasize that this is a technical reversal of the rejections under 35 U.S.C. §§ 102 and 103, and not a reversal based upon the merits of the rejections. Thus, without reaching the merits of these rejections, we REVERSE the Examiner’s prior art rejection of claims 26–36 under 35 U.S.C. §§ 102(b) and 103(a). We enter the following NEW GROUND OF REJECTION for these claims pursuant to our authority under 37 C.F.R. § 41.50(b). NEW GROUND OF REJECTION UNDER 35 U.S.C. § 112, second paragraph - Indefiniteness Claims 26–36 are rejected under 35 U.S.C. § 112, second paragraph. The text of 35 U.S.C. § 112, second paragraph requires “[t]he specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” “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). Claims are in compliance with 35 U.S.C. § 112, second paragraph if “the claims, read in light of the specification, reasonably apprise those skilled in the art both of the utilization and scope of the Appeal 2020-001778 Application 14/010,792 5 invention, and if the language is as precise as the subject matter permits.” Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1385 (Fed. Cir. 1986) (citing Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 624 (Fed. Cir. 1985)). Thus, the test for determining the question of indefiniteness may be formulated as whether the claims “set out and circumscribe a particular area with a reasonable degree of precision and particularity.” In re Moore, 439 F.2d 1232, 1235 (CCPA 1971). With regard to the reasonableness standard, one must consider the language in the context of the circumstances. Packard, 751 F.3d at 1313. Language is an imprecise method of drawing boundaries delineating patent rights, thus unreasonable precision cannot be demanded. Id. On the other hand, the claims must notify the public of what they are excluded from making and using. Id. For this reason, while exact precision is not required, an applicant is required to use language as precise as the subject matter reasonably permits. Id. Claim 26 recites an electrochemical test device. However, the claim language raises an issue of indefiniteness because it is not clear whether the claim positively recites a reagent disposed on one of the electrodes and the side walls of the sample-receiving space as the Specification describes. The pertinent claim 26 language recites wherein in the test device prior to introduction of a liquid sample, the reagent is disposed in a dried layer, covering as a coating at least a portion of the first or second electrode and at least a portion of the side walls, said layer extending as a coating contiguously from the covered electrode and along the side walls (emphasis added). Appeal 2020-001778 Application 14/010,792 6 The Specification describes an inventive electrochemical test device comprising a base layer with a first electrode thereon and a top layer with a second electrode thereon. The two electrodes are separated by a spacer layer having an opening therein, such that a sample-receiving space is defined with one electrode on the top surface, the other electrodes on the bottom surface and side walls formed from edges of the opening in the spacer. Spec. ¶ 6. The Specification further describes the inventive electrochemical test device as comprising reagents for performing the electrochemical reaction “deposited not only on [one of the] electrode[s], but also on the side walls of the sample- receiving space.” Id. ¶ 7. The Specification describes that arranging the reagents as described “results in a signal profile without the lag or with a reduced lag.” Id. The above noted claim language does not clearly recite the disposed reagent layer as part of the electrochemical device, but, instead, appears to recite the reagent layer as a chemical applied to the device before use. Thus, the claim’s recitation that the reagent layer is disposed in the testing device prior to introduction of a liquid sample is ambiguous, vague, and indefinite because, when read in light of the specification, it does not reasonably apprise those skilled in the art both of the utilization and scope of the invention. Packard, 751 F.3d at 1313; Hybritech, 802 F.2d at 1385. After careful review of the record before us, we determine that the language of claim 26 does not particularly point out and distinctly claim the subject matter which the applicant regards as the invention. That is, we are Appeal 2020-001778 Application 14/010,792 7 unable to determine the metes and bounds of the subject matter of independent claim 26 and its dependent claims. Accordingly, on this record, claims 26–36 are indefinite for the reasons given above. Method Claims 37–47 REJECTIONS UNDER 35 U.S.C. §§ 102 AND 103 We refer to the Examiner’s Final Office Action for a complete statement of the rejection of claims 37–47. Final Act. 2–9. With respect to the Examiner’s rejection under 35 U.S.C. § 102(b), Appellant has identified reversible error because the Examiner does not point to any portion of Hodges that describes a method of making an electrochemical testing device comprising a step of drying a liquid reagent to form a dried reagent layer that contiguously covers at least a portion of the first electrode and at least a portion of the side walls. Appeal Br. 14. With respect to the Examiner’s rejection under 35 U.S.C. § 103(a), Appellant has identified reversible error in the Examiner’s determination of obviousness based on Hodges because the Examiner fails to provide “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), quoted with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). See Final Act. 6; Appeal Br. 14. Appeal 2020-001778 Application 14/010,792 8 The Examiner relies on Feldman3 as an evidentiary reference4 in both rejections. The Examiner cites Feldman to establish that Hodges’s disclosure of pipetting to apply a reagent coating would inherently result in a contiguous reagent coating across an electrode and along the sidewalls of an electrochemical device. Final Act. 6–7, 9–10; Ans. 11; Hodges col. 9, ll. 62–65; see Feldman Figure 1D, ¶¶ 23, 26–28. That is, the Examiner relies on Feldman to address the key feature of the invention. See Spec. ¶ 7. But, in this case, the Examiner assumes that Hodges’s pipetting technique, which is not described, would result in a coating profile shown in Feldman’s description of a prior art embodiment shown in Figure 1D without directing us to any portion of Feldman that describes the coating technique used for the Figure 1D embodiment. Moreover, the Examiner finds Feldman’s teachings crucial to support a rejection. See generally Final Act. and Ans. Yet, the Examiner did not include this reference in the statement of the rejection. Reliance on such a crucial reference to support positions when responding to Appellant’s 3 US 2014/0026646 Al, published Jan. 30, 2014. 4 Application No. 14/010,792 filed August 27, 2013, which is the Application from which the appeal is taken, is a continuation of Application No. 10/908,664, filed 05/21/2005, now U.S. Patent No. 8,617,365. In addition, Application No. 10/908,664 claims Priority from Provisional Application No. 60/521555, filed 05/21/2004. Feldman, published January 30, 2014, is based on Application No. 13/949,996, filed July 24, 2013, which issued as U.S. Patent No. 9,535,027. Application No. 13/949,996 claims Priority from Provisional Application 61/675696, filed 07/25/2012. While the use of Feldman as an evidentiary reference may be appropriate under certain circumstances, Feldman is not prior art against the claimed invention because it does not antedate the earliest effective filing date for Application No. 14/010,792. Appeal 2020-001778 Application 14/010,792 9 arguments without including it in the statement of rejection is inappropriate. See In re Hoch, 428 F.2d 1341, 1342 n.3 (CCPA 1970) (“Where a reference is relied on to support a rejection, whether or not in a ‘minor capacity,’ there would appear to be no excuse for not positively including the reference in the statement of the rejection.”). That is not to say an Examiner must present any considered evidence by way of a reference included in a statement of rejection. Our reviewing court has held that other references or extrinsic materials may be cited in the rejection to explain an element in the cited prior art reference, as long as they are not used to expand on the teachings of the primary reference. In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991). However, in this case, the Examiner relies on Feldman to expand inappropriately on the teachings of Hodges. Accordingly, we reverse the Examiner’s prior art rejections of claims 37–47 under 35 U.S.C. §§ 102(b) and 103(a) for the reasons Appellant presents and we give above. CONCLUSION We procedurally reverse the prior art rejections of claims 26–36 under 35 U.S.C. §§ 102 and 103. We enter a new ground of rejection for claims 26–36 under 35 U.S.C. § 112, second paragraph. We reverse the prior art rejections of claims 37–47 under 35 U.S.C. §§ 102(b) and 103(a) for the reasons Appellant presents and we give above. Appeal 2020-001778 Application 14/010,792 10 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 26–44, 46, 47 102(b)/ 103(a) Hodges 26–44, 46, 47 45 103(a) Hodges, Nankai 45 26–36 112, 2nd paragraph Indefiniteness 26–36 Overall Outcome 26–47 26–36 TIME PERIOD FOR RESPONSE 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.” Section 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 Appeal 2020-001778 Application 14/010,792 11 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. REVERSED NEW GROUND OF REJECTION (37 C.F.R. § 41.50(b))