Sylvain CormierDownload PDFPatent Trials and Appeals BoardJun 2, 20212020003710 (P.T.A.B. Jun. 2, 2021) 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. 13/519,798 06/28/2012 Sylvain Cormier W-680-US2 (WAT-017US) 1683 14299 7590 06/02/2021 Schmeiser, Olsen & Watts LLP 33 Boston Post Road West Suite 410 Marborough, MA 01752 EXAMINER PEO, KARA M ART UNIT PAPER NUMBER 1777 NOTIFICATION DATE DELIVERY MODE 06/02/2021 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): docketing@iplawusa.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SYLVAIN CORMIER Appeal 2020-003710 Application 13/519,798 Technology Center 1700 Before CATHERINE Q. TIMM, N. WHITNEY WILSON, and JENNIFER R. GUPTA, Administrative Patent Judges. TIMM, 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, 4, 6, 7, 11, 12, and 33–36. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART. 1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Waters Technologies Corporation. Appeal Br. 1. Appeal 2020-003710 Application 13/519,798 2 CLAIMED SUBJECT MATTER The claims are directed to an online sample manager of a liquid chromatography system. See, e.g., claims 1 and 36. In a liquid chromatography application, a sample manager contains a sample to be analyzed by a liquid chromatography column and pumps to deliver solvents that are mixed with the sample. Spec. 1:11–16. Sampling at various times or at different points along a production line of, for instance, a drug manufacturing apparatus is often used to ensure that a manufacturing batch is being created to specification. Spec. 1:17–23. “Typically, however, the manner of acquiring samples for analysis is manually intensive; an individual takes a sample manually from a process line, carries the sample into the liquid chromatography system, and loads it for injection and analysis.” Spec. 1:24–26. Appellant’s online sample manager allows for automatic sampling directly from a process source. Spec. 4:2–13. According to the Specification, “[a]s used herein, ‘online’ means that the sample manager is connected directly to a process (or production) line to acquire samples automatically from the process line in approximately real time without manual intervention, then dilute, load, and inject the acquired process samples for subsequent chromatographic analysis.” Spec. 4:4–8. Appellant’s claims are limited to a specific arrangement of a fluidic tee, pumps, valves, and sample loop within Appellant’s online sample manager. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. An online sample manager of a liquid chromatography system, comprising: Appeal 2020-003710 Application 13/519,798 3 a fluidic tee having a first inlet port, a second inlet port, and an outlet port; a diluent pump in fluidic communication with a diluent source and the first inlet port of the fluidic tee; a process-selection valve having an intake port in fluidic communication with a process line to receive a process sample therefrom and having an outlet port; a process sample pump in fluidic communication with the outlet port of the process-selection valve and the second inlet port of the fluidic tee, the process sample pump configured to move an acquired process sample into the second inlet port of the fluidic tee while the diluent pump is moving the diluent into the first inlet port of the fluidic tee such that the process sample and the diluent are in the fluidic tee at a same time and merge to produce a diluted process sample that flows out from the outlet port of the fluidic tee; an injection valve having a first injection valve port in fluidic communication with the outlet port of the fluidic tee to receive the diluted process sample therefrom, a second injection valve port in fluidic communication with a solvent delivery system to receive a solvent composition stream therefrom, a third injection valve port and a fourth injection valve port; and a sample loop configured to store the diluted process sample and having one end directly coupled to the third injection valve port and an opposite end directly coupled to the fourth injection valve port. Appeal Br. 12 (Claims Appendix). Appeal 2020-003710 Application 13/519,798 4 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Friswell US 4,094,196 June 13, 1978 Wheat US 6,790,361 B2 Sept. 14, 2004 Petro US 2006/0054543 A1 Mar. 16, 2006 REJECTIONS Claim 34 is rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112, second paragraph, as being indefinite. Final Act. 2. Claim 34 is rejected under 35 U.S.C. § 112(d) or 35 U.S.C. § 112, fourth paragraph, as being of improper dependent form. Final Act. 3. Claims 1, 4, 11, 12, and 33–36 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wheat in view of Petro. Final Act. 3. Claims 6 and 7 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wheat and Petro and further in view of Friswell. Final Act. 13. OPINION The Obviousness Rejections The Examiner rejects claims 1, 4, 11, 12, and 33–36 as obvious over Wheat in view of Petro and adds Friswell to reject claims 6 and 7. All of the rejected claims require an online sample manager of a liquid chromatography system that includes a fluidic tee, a process-selection valve, and an injection valve. See, e.g., claims 1 and 36. The claims further require the tee and valves include various inlet and outlet ports that are in fluidic communication with each other and with pumps in specified ways and such that a sample loop is created. For instance, the two inlet ports of the fluidic Appeal 2020-003710 Application 13/519,798 5 tee are in fluidic communication with a diluent pump and a process sample pump, respectively, while the outlet of the fluidic tee is in fluid communication with an injection valve. The process-selection valve is in fluidic communication with a process line, i.e., a manufacturing process line or production line from which the sample is taken (e.g., a drug manufacturing process, beaker reaction, exit line (cleaning validation), reaction chamber, fermentation reaction, etc.) and the process-section valve outlet is fluidic communication with the process sample pump. Spec. 1:17– 23; 4:2–13; 5:5–15. Two valve ports of the injection valve are directly coupled together to form a sample loop configured to store the diluted process sample. Spec. 8:21–24. The Examiner finds that Wheat’s fitting 24, shown in Figure 2, is the required fluidic tee, Petro’s injection valve 112 is the required process- selection valve, and Petro’s splitter 308 is the required injection valve. Final Act. 3–6. According to the Examiner, “[i]t would have been obvious to one of ordinary skill in the art at the time of the invention to have incorporated the process-selection and injection valve system, as taught by Petro, into the chromatography system of Wheat in order to sample discrete samples from multiple sources.” Final Act. 6. The Examiner also finds that Petro teaches a sample loop including heated line 314, detector 126, waste 120, and splitter 308. Final Act. 5; see also Ans. 24 (annotated Figure 3). We agree with Appellant that the Examiner’s reasoning falls short of establishing a suggestion within the prior art for combining Wheat’s fluidic tee and Petro’s valves 112 and 308 in a manner that would arrive at the online sample manager of Appellant’s claims. Appeal Br. 6–7. We further agree with Appellant that Petro’s post-column loop including heated line Appeal 2020-003710 Application 13/519,798 6 314, detector 126, waste 120, and splitter 308 are not a “sample loop” as that terminology is understood in the art and used by Appellant. Appeal Br. 7–8. First, it is unclear from the rejection how the ordinary artisan would have arrived at the combination of the fluidic tee and process-section valve required by Appellant’s claims based on only knowledge within the art. In Figure 2, Wheat suggests a fluidic tee (fitting 24) that is in fluidic communication with diluent pump (gradient pump 21) and an injector 23 that receives a sample-containing mobile phase. Wheat col. 8, ll. 3–67. The fluidic tee (fitting 24) combines the diluent and dissolved sample and passes it to column 25. Id. Petro uses injection valve 112 to accomplish similar sample and diluent mixing functions. Petro ¶ 60; Figs. 1, 3. Petro’s injection valve 112 includes an injection port that receives samples from a sample source, such as an online sampling system in a polymerization process line (Fig. 1 at 114; Fig. 2A at 212), inlet ports that receive solvents (Fig. 2A at 204 and 206), and a sample loop (Fig. 2A at 202) that can inject discrete sample volumes into the mobile phase of solvents into the column (Fig. 3 at 106). At best, the ordinary artisan would have used Petro’s injection valve 112 in place of Wheat’s fluidic tee (fitting 24). The Examiner offers no adequate reasoning as to why the ordinary artisan would have included both the fluidic tee of Wheat and the injection valve 112 of Petro in a sample manager. Second, the Examiner finds that Petro’s valve 308, shown in Figure 3, is an injection valve, but valve 308 is not the injection valve required by the claims. The claims require an injection valve having an injection valve port in fluidic communication with the outlet port of the fluidic tee to receive the diluted process sample therefrom and with injection valve ports directly coupled together to form a sample loop, which stores the diluted process Appeal 2020-003710 Application 13/519,798 7 sample. Petro’s valve 308 resides after the column, not before, and does not have valve ports connected to a sample loop. See Fig. 3. Nor has the Examiner provided any persuasive technical reasoning supporting a finding of a suggestion for arranging the fluidic tee of Wheat and valve 308 of Petro in the arrangement required by the claims. Lastly, we agree with Appellant that “sample loop” has an established meaning in the prior art as evidenced by the quote from chromatograph- online.org and the Examiner’s broad interpretation of “sample loop” as encompassing the post-column recycling loop taught by Petro is unreasonable. Appeal Br. 7–8; Reply Br. 5. Petro supports Appellant’s interpretation of “sample loop.” See Petro ¶¶ 67–68 (describing a passageway that holds a discrete volume of a sample for injection into a mobile phase and through the chromatography column). And the Examiner offers no persuasive evidence in response. Ans. 22. The Examiner’s application of Friswell does not cure the deficiencies of Wheat and Petro. Thus, we do not sustain the obviousness rejection of any claim. The Rejections under 35 U.S.C. § 112 The Examiner rejects claim 34 as indefinite under the second and fourth paragraphs of 35 U.S.C. § 112. Final Act. 2–3. Claim 34 depends from claim 33. Claim 33 requires the injection valve have a fifth injection valve port and requires the fifth injection valve port be “in fluidic communication with a chromatographic column.” Claim 34 further recites that the online sample manager of claim 33 further comprises the chromatographic column. Appeal 2020-003710 Application 13/519,798 8 The Examiner determines that the scope of claim 34 is unclear because claim 33 already requires a chromatographic column and, thus, it is unclear what claim 34 additionally requires. Final Act. 2. Appellant contends that claim 34 is clear because claim 33 recites only that the fifth injection valve is in fluidic communication with a chromatographic column and does not affirmatively require the online sample manager include the chromatographic column, while claim 34 expressly requires chromatographic column be in the online sample manager. Appeal Br. 3. The problem is that Appellant’s argument is based on semantics that are irrelevant to the scope of the claim from an infringement standpoint. Whether the chromatographic column is defined as within the online sample manager or outside of it, the column must be present in order to meet the requirements of claim 33. If the fifth valve is not in fluidic communication with a chromatographic column, there is no infringement. This is so even if one draws the boundary of the online sample manager before the chromatographic column or after it. Redrawing the boundary to include the chromatographic column by expressly requiring the chromatographic column to be in the online sample manager makes no difference to the scope of the claims in a patentability sense. Thus, we agree with the Examiner that claim 34 is unclear and improperly dependent as it is not clear what claim 34 adds to claim 33 in a patentability sense. We sustain the Examiner’s rejections of claim 34 under 35 U.S.C. § 112, second and fourth paragraphs for indefiniteness and improper dependency. Appeal 2020-003710 Application 13/519,798 9 CONCLUSION The Examiner’s decision to reject claim 34 under 35 U.S.C. § 112 is affirmed, but the Examiner’s decision to reject claims 1, 4, 6, 7, 11, 12, and 33–36 under 35 U.S.C. § 103(a) is reversed. Because one claim remains rejected, we affirm in part. DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 34 112, second paragraph Indefiniteness 34 34 112, fourth paragraph Improper dependency 34 1, 4, 11, 12, 33–36 103(a) Wheat, Petro 1, 4, 11, 12, 33–36 6, 7 103(a) Wheat, Petro, Friswell 6, 7 Overall Outcome 34 1, 4, 6, 7, 11, 12, 33, 35, 36 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 IN PART Copy with citationCopy as parenthetical citation