Quest Diagnostics Investment Inc.

Patent Trials and Appeals Board

Mar 8, 2022

2021000399 (P.T.A.B. Mar. 8, 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. 14/635,586 03/02/2015 Mildred M. GOLDMAN 054769-9103 2842 109855 7590 03/08/2022 Quest Diagnostics Attn: Legal Department 33608 Ortega Highway San Juan Capistrano, CA 92675 EXAMINER FRITCHMAN, REBECCA M ART UNIT PAPER NUMBER 1797 NOTIFICATION DATE DELIVERY MODE 03/08/2022 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): ipdocketing@foley.com joel.s.white@questdiagnostics.com joshua.e.kim@questdiagnostics.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE _________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MILDRED M. GOLDMAN, NIGEL J. CLARKE and RICHARD E. REITZ __________ Appeal 2021-000399 Application 14/635,586 Technology Center 1700 ___________ Before ADRIENE LEPIANE HANLON, SHELDON M. McGEE, and JANE E. INGLESE, Administrative Patent Judges. HANLON, Administrative Patent Judge. DECISION ON APPEAL A. STATEMENT OF THE CASE The Appellant1 filed an appeal under 35 U.S.C. § 134(a) from an Examiner’s decision rejecting claims 1-12, 23-32, and 43-53. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real party in interest as Quest Diagnostics Investments LLC. Appeal Brief dated May 7, 2020 (“Appeal Br.”), at 1. Appeal 2021-000399 Application 14/635,586 2 According to the Appellant, “[t]he claimed method is directed to ionizing purified estradiol from [a] test sample to produce one or more precursor ions comprising a mass/charge ratio of 271.14 ± .5, which results from loss of a hydrogen molecule having a molecular mass of 1 g/mol.” Appeal Br. 8. The Appellant discloses that the mass/charge ratio for estradiol in the negative ion mode is 271.14 ± 0.5. Spec. ¶¶ 39, 95. The mass/charge ratio for estradiol in the positive ion mode, on the other hand, is said to be 255.07 ± 0.5. Spec. ¶¶ 38, 94. Representative claim 1 is reproduced below from the Claims Appendix to the Appeal Brief. The limitations at issue are italicized. 1. A method for determining the amount of estradiol in a test sample said method comprising: (a) purifying estradiol from said test sample by liquid chromatography; (b) ionizing the purified estradiol from said test sample to produce one or more ions detectable by tandem mass spectrometry, wherein said one or more ions comprise an ion with a mass/charge ratio of 271.14 ± 0.5; and (c) detecting the amount of the estradiol ion(s) by tandem mass spectrometry, wherein the amount of the estradiol ion(s) is related to the amount of estradiol in said test sample; wherein the limit of quantitation of the method is less than or equal to 25 pg/mL and estradiol is not derivatized prior to mass spectrometry. Appeal Br. 12. The Examiner maintains the following grounds of rejection on appeal:2 2 The Examiner withdrew the rejection of claims 1-12, 23-32, and 43-53 under 35 U.S.C. § 112, second paragraph, as indefinite. Examiner’s Answer dated August 17, 2020 (“Ans.”), at 3. Appeal 2021-000399 Application 14/635,586 3 (1) claims 1-5, 11, 12, 23-28, and 32 under 35 U.S.C. § 103(a) as unpatentable over Soldin3 in view of Grant;4 and (2) claims 6-10, 29-31, and 43-53 under 35 U.S.C. § 103(a) as unpatentable over Soldin in view of Grant, further in view of Polson.5 B. DISCUSSION The Examiner finds Soldin uses liquid chromatography to purify and tandem mass spectrometry to analyze one or more hormones, including estradiol, as claimed. Non-Final Act. 5 (citing Soldin ¶ 86).6 According to Soldin, the invention is highly sensitive for estrogens and, like the claimed invention, does not require a derivation reaction prior to analysis. Soldin ¶¶ 36, 37; see also Non-Final 5 (citing Soldin ¶ 100). The Examiner also finds Soldin teaches ionization of estradiol in either negative or positive ion mode. Non-Final Act. 5 (citing Soldin ¶ 92). When estradiol is analyzed in negative ion mode, the Examiner finds that “the claimed mass/charge ratios would be found since the mass charge is a material property of the detected chemical.” Non-Final Act. 5 (citing Soldin ¶ 92). The Appellant does not direct us to any error in the Examiner’s finding that “mass charge is a material property of the detected chemical.” Non-Final Act. 5. Nonetheless, the Appellant argues that Soldin does not disclose or suggest that the mass/charge ratio (m/z) of estradiol is 271.14 ± 0.5 as recited in claim 1. Appeal Br. 8. In response, the Examiner explains that 3 US 2004/0235193 A1, published November 25, 2004 (“Soldin”). 4 US 2008/0128606 A1, published June 5, 2008 (“Grant”). 5 Cara Polson et al., Optimization of protein precipitation based upon effectiveness of protein removal and ionization effect in liquid chromatography-tandem mass spectrometry, 785 J. of Chromatography B 263-275 (2003) (“Polson”). 6 Non-Final Office Action dated April 9, 2019. Appeal 2021-000399 Application 14/635,586 4 due to the laws of physics, and how mass spectrometry works, if it is claimed that a compound is detected, and specifically, that the same compound [e.g., estradiol] is detected by two different sources . . . by the same method in two different places, and more specifically when the same detection technique is used in both of the sources to detect the compound, in the instant case by mass spectrometry, the compound will in fact have the same mass/charge ratio in both places, as a material property of the compound. Ans. 4. The Examiner finds, and the Appellant does not dispute, that Soldin teaches the Appellant’s claimed method. Ans. 4-5. Therefore, a preponderance of the evidence supports a finding that the mass/charge ratio of estradiol, detected in the negative ion mode according to Soldin’s method, is inherently 271.14 ± .5.7 See Ans. 6; In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (where the claimed and prior art products are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product). As for the limit of quantitation (LOQ) recited in claim 1, the Examiner finds Grant teaches detecting estradiol with a LOQ of 1 pg/mL. Non-Final Act. 5. The Appellant argues that Grant achieves a LOQ of 1 pg/mL by dehydrating estradiol. Appeal Br. 9. In contrast, the Appellant argues that “the presently claimed subject matter does not dehydrate estradiol to increase sensitivity, and yet surprisingly achieved a comparable LOQ of 2 pg/ml.”8 Appeal Br. 9 (emphasis added). 7 Notably, Soldin, like the Appellant, discloses that the mass/charge ratio of estradiol in positive ion mode is 255. Soldin Fig. 1; Spec. ¶¶ 38, 94. 8 The Appellant does not direct us to any evidence of unexpected results. Appeal 2021-000399 Application 14/635,586 5 The Appellant’s argument is not persuasive of reversible error. Grant discloses that “estradiol is dehydrated to reduce the complexity of the MS/MS [i.e., tandem mass spectroscopy] spectrum, such that the sensitivity of estradiol detection is increased.” Grant ¶ 99. In one embodiment, Grant discloses that “the sample is heated in the interface where the sample is transferred to the mass spectrometer.” Grant ¶ 104 (emphasis added). Similarly, the Appellant discloses that the liquid solvent/analyte exits the HPLC (high performance liquid chromatography) column and flows to the heated nebulizer interface of a tandem mass spectrometer where it is converted to vapor in the heated tubing of the interface. Spec. ¶ 93. Based on the foregoing, we conclude that claim 1 does not exclude the dehydrating step disclosed in Grant.9 See In re Herz, 537 F.2d 549, 551 (CCPA 1976) (“It is axiomatic that claims are given their broadest reasonable construction consistent with the specification.”). In sum, the weight of the evidence supports the Examiner’s conclusion of obviousness as to claim 1. The Appellant does not present arguments in support of the separate patentability of any of the remaining claims on appeal. Therefore, the obviousness rejections of claims 1-12, 23-32, and 43-53 are sustained. C. CONCLUSION The Examiner’s decision is affirmed. In summary: 9 Claim 1 recites “[a] method for determining the amount of estradiol in a test sample said method comprising” steps (a), (b), and (c). Appeal Br. 12 (emphasis added). “[T]he term ‘comprises’ [or ‘comprising’] permits the inclusion of other steps, elements, or materials.” In re Baxter, 656 F.2d 679, 686 (CCPA 1981). Thus, for that additional reason, claim 1 does not exclude the dehydrating step disclosed in Grant. Appeal 2021-000399 Application 14/635,586 6 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-5, 11, 12, 23-28, 32 103(a) Soldin, Grant 1-5, 11, 12, 23-28, 32 6-10, 29-31, 43-53 103(a) Soldin, Grant, Polson 6-10, 29-31, 43-53 Overall Outcome 1-12, 23-32, 43-53 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED