3i Diagnostic, Inc.

Patent Trials and Appeals Board

Jan 4, 2022

2020006538 (P.T.A.B. Jan. 4, 2022)

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. 14/893,689 11/24/2015 Rajesh KRISHNAMURTHY 2978.0001C 5315 27896 7590 01/04/2022 EDELL, SHAPIRO & FINNAN, LLC 9801 Washingtonian Blvd. Suite 750 Gaithersburg, MD 20878 EXAMINER KWAK, DEAN P ART UNIT PAPER NUMBER 1798 NOTIFICATION DATE DELIVERY MODE 01/04/2022 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): epatent@usiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RAJESH KRISHNAMURTHY Appeal 2020-006538 Application 14/893,689 Technology Center 1700 Before BEVERLY A. FRANKLIN, DONNA M. PRAISS, and N. WHITNEY WILSON, Administrative Patent Judges. WILSON, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s December 2, 2019 decision to finally reject claims 1-6, 8-16, 19-22, and 24-26 (“Final Act.”). We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellant refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as 31 Diagnostics, Inc. (Appeal Br. 3). Appeal 2020-006538 Application 14/893,689 2 CLAIMED SUBJECT MATTER Appellant’s disclosure is directed to a system for detecting the presence of bacteria and small microorganisms (Abstract). The system can make this determination from a sample which includes both non-microbial cells and microorganisms (Appeal Br. 5). The system includes a microfluidic separation stage, an infrared spectrometric stage, and an identification stage (Appeal Br. 5). Claim 1, reproduced below from the Claims Appendix, is illustrative of the claimed subject matter: 1. A detection system for identifying microorganisms within a sample, the sample including non-microbial cells and microorganisms, the detection system comprising: a microfluidic separation stage comprising a lysis structure that includes an inlet, an outlet, and microporous surfaces disposed between the inlet and the outlet to receive the sample and selectively lyse non-microbial cells while maintaining intact microorganisms in the sample when the sample flows between the inlet and the outlet and through the microporous surfaces of the lysis structure; an infrared spectrometric stage to receive the sample from the microfluidic separation stage and perform infrared spectrometric analysis on the sample; and an identification stage to identify intact microorganisms based upon the infrared spectrometric analysis. Appeal 2020-006538 Application 14/893,689 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Chiu et al. US 7,767,435 B2 August 3, 2010 Link et al. US 2008/0003142 A1 January 3, 2008 Klapperich et al. US 2010/0203521 A1 August 12, 2010 Jiashu Sun et al., Double spiral microchannel for label-free tumor cell separation and enrichment, 12 Lab Chip, 3952-3960 (2012) (“Sun”) Microfluidics for Biological Applications 49 (Wei-Cheng Tian & Erin Finehout eds., Springer 2008) (“Tian”) REJECTIONS 1. Claims 1-4, 9-11, and 13-16, and 20 are rejected under 35 U.S.C. § 102(a)(1) as anticipated by Link. 2. Claims 5, 6, 22, 25, and 26 are rejected under 35 U.S.C. § 103 as unpatentable over Link. 3. Claim 12 is rejected under 35 U.S.C. § 103 as unpatentable over Link in view of Tian. 4. Claim 24 is rejected under 35 U.S.C. § 103 as unpatentable over Link in view of Sun. 5. Claims 1-4, 8-11, 14-16, 19, and 21 are rejected under 35 U.S.C. § 102(a)(1) as anticipated by Chiu. 6. Claims 1-6, 8-11, 13-16, 19-22, 25, and 26 are rejected under 35 U.S.C. § 103 as unpatentable over Klapperich in view of Chiu or Link. 7. Claim 12 is rejected under 35 U.S.C. § 103 as unpatentable over Klapperich in view of Chiu or Link, and further in view of Tian. Appeal 2020-006538 Application 14/893,689 4 The rejection of claims 6, 21, and 24 under 35 U.S.C. § 112(b) as indefinite has been withdrawn (Ans. 26). OPINION Rejections 1-4. “A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012) (citing Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1336-37 (Fed. Cir. 2010)). In this instance, Appellant contends that Link does not teach (1) separating microbial cells from non-microbial cells, or (2) a microfluidic separation stage which comprises a lysis structure that includes an inlet, an outlet, and microporous surfaces disposed between the inlet and the outlet to receive the sample and selectively lyse non-microbial cells while maintaining intact microorganisms in the sample when the sample flows between the inlet and the outlet and through the microporous surfaces of the lysis structure (Appeal Br. 11). With regards to difference (2) above, Appellant contends that Link does not describe a structure or technique for lysing cells, and only mentions lysing in the context of lysing cells prior to the assay step to release the contents of the cell within a droplet (Appeal Br. 11-12, citing Link ¶ 438). According to Appellant, Link at best discloses “lysing of the cells of interest so as to release their contents for further processing,” not a disclosure of selective lysing of cells not of interest (Appeal Br. 12). The Examiner finds, Regarding the “lysis structure . . . selectively lyse non- microbial cells while maintaining intact microorganisms in the sample Appeal 2020-006538 Application 14/893,689 5 when the sample flows between the inlet and the outlet and through the microporous surfaces of the lysis structure”, it is noted that since the claim does not specify any structural configuration of the lysis structure for providing the selective lyse feature, the structures taught by Link et al. [are] capable of the limitation as much as the claim broadly presents. (Final Act. 4). The Examiner determines that the selective lysing limitation is a process limitation, does not further differentiate the claimed structure from Link, and is not accorded patentable weight (Final Act. 5). The Examiner further finds that Link “teach[es] structural elements capable of selective lysing [of] cells through chemical means (the use of surfactants capable of lysing cells) and mechanical means (the use of packed microporous beads and driving forces capable of disrupting of cells by shear stress)” (Ans. 30-31). We determine that Appellant has demonstrated reversible error in the Examiner’s finding that Link’s detection system anticipates claim 1. In particular, the Examiner’s finding that Link teaches structural elements capable of selective lysing cells through chemical means and mechanical means is not sufficient to support the finding of anticipation. That is, the claim language requires that the microfluidic stage include microporous surfaces disposed between its inlet and outlet to receive the sample and selectively lyse non-microbial cells while maintaining intact microorganisms in the sample when the sample flows between the inlet and the outlet and through the microporous surfaces of the lysis structure. Therefore, from a structural perspective, the claimed device has to be able to perform the selective lysing of non-microbial cells. The Specification discloses that this can be done by forcing a sample through microporous surfaces that contain Appeal 2020-006538 Application 14/893,689 6 pores with a diameter of about 1-10 microns, or by the use of chemicals such as polysorbates, triton X-100, sodium cholate, or tri(n-butyl)phosphate which can disrupt cell walls (Spec. ¶ 80). The Examiner’s finding that Link’s structure meets the claimed functional requirements is not adequately supported by the evidence of record. Although Link discloses the use of packed microporous beads, there is no indication that the resulting structure would actually be able to selectively lyse the non-microbial cells as required by the claim. In other words, although packed microporous beads might be capable of selectively lysing the non-microbial cells, there is no evidence or indication that Link’s microporous beads are so-capable. Moreover, as explained in detail by Appellant, Link does not provide any teaching or suggestion that such selective lysing would be desirable (Appeal Br. 11, 13-14). Thus, we determine that the evidence of record does not support a finding of anticipation over Link, because Link does not teach the structure (including the functionality) recited in the claims. Nor are the obviousness rejections based on Link adequately supported by the evidence of record. Accordingly, we reverse Rejections 1, 2, 3, and 4. Rejection 5. The anticipation rejection of claims 1-4, 8-11, 14-16, 19, and 21 over Chiu suffers from the same defect as the anticipation rejection over Link. That is, the preponderance of the evidence of record does not show that Chiu’s system has microporous surfaces to receive a sample and selectively lyse non-microbial cells while maintaining intact microorganisms. In this regard, the Examiner finds, as with Link, that Chiu’s structures are capable of performing the selective lysing function (Final Act. 14). However, as with Link, the record lacks sufficient evidence Appeal 2020-006538 Application 14/893,689 7 to show that Chiu’s system can actually perform the selective lysing step. Accordingly, the anticipation rejection must be reversed. Rejections 6 and 7. The Examiner finds that Klapperich teaches a detection system which includes a microfluidic separation stage with “a lysis structure,” but that it fails to teach that its device comprises an infrared spectrometric stage or an identification stage (Final Act. 16, citing Klapperich Abstract, FIG. 1, ¶¶ 35, 68). The Examiner finds these elements are taught by both Link and Chiu and that it would have been obvious to make the asserted combination for the advantages set forth in the secondary references (Final Act. 17). Appellant contends that Klapperich discloses a system in which microbial cells are lysed, which is completely the opposite of what the claims require (i.e., the non-microbial cells are lysed while the microbial cells are passed though without lysing) (Appeal Br. 23). Moreover, according to Appellant, Klapperich fails to teach selectively lysing non- microbial cells while maintaining intact microorganisms in the sample (id.). The Examiner responds by finding that, as was the case with Link and Chiu, Klapperich’s system is capable of lysing cells (Ans. 42). The Examiner states that the functional limitation of selectively lysing the non- microbial cells “must result in a structural difference between the claimed invention and the prior art” (id.). However, the selective lysing functionality of the claimed invention is a structural feature. That is, for the system to have the claimed functionality, it must have a structure which provides that functionality. There is insufficient evidence of record to support a finding that Klapperich’s system has, or would have suggested, this functionality. Appeal 2020-006538 Application 14/893,689 8 Accordingly, we reverse the obviousness rejections based on Klapperich. CONCLUSION The Examiner’s rejections are reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-4, 9-11, 13-16, 20 102(a)(1) Link 1-4, 9-11, 13-16, 20 5, 6, 22, 25, 26 103 Link 5, 6, 22, 25, 26 12 103 Link, Tian 12 24 102 Link, Sun 24 1-4, 8-11, 14-16, 19, 21 102(a)(1) Chiu 1-4, 8-11, 14-16, 19, 21 1-6, 8-11, 13-16, 19- 22, 25, 26 103 Klapperich, Chiu Link 1-6, 8-11, 13-16, 19- 22, 25, 26 12 103 Klapperich, Chiu Link, Tian 12 Overall Outcome 1-6, 8-16, 19-22, 24- 26 REVERSED