2020001996 (P.T.A.B. Jan. 4, 2021)

Cameron PIRON et al.

Patent Trials and Appeals BoardJan 4, 2021

2020001996 (P.T.A.B. Jan. 4, 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. 15/534,037 06/08/2017 Cameron Anthony PIRON P4826US00 7633 54640 7590 01/04/2021 PERRY + CURRIER INC. 1300 YONGE STREET SUITE 500 TORONTO, ONTARIO M4T-1X3 CANADA EXAMINER KISH, JAMES M ART UNIT PAPER NUMBER 3799 NOTIFICATION DATE DELIVERY MODE 01/04/2021 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@pckip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte CAMERON ANTHONY PIRON, CHAD TYLER HARRIS, JEFF STAINSBY, ALEXANDER GYLES PANTHER, and TIMOTHY JAMES SCHOLL ____________________ Appeal 2020-001996 Application 15/534,037 Technology Center 3700 ____________________ Before JOHN C. KERINS, BRETT C. MARTIN, and LEE L. STEPINA, Administrative Patent Judges. KERINS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the Examiner’s Decision rejecting claims 1–11, 13, and 14, the only claims now pending in the application. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 The term “Appellant” is used herein to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Synaptive Medical (Barbados) Inc., a subsidiary of Synaptive Medical Inc., as the real party in interest. Appeal Br. 2. Appeal 2020-001996 Application 15/534,037 2 CLAIMED SUBJECT MATTER Appellant’s invention relates to a diagnostic method for imaging immune response of soft tissue to therapy using a magnetic resonance imaging system. Independent claim 1 is illustrative, and is reproduced below: 1. A diagnostic method for imaging immune response of soft tissue to therapy using a magnetic resonance imaging system, comprising: prior to therapy, administering a contrast agent to the soft tissue, wherein said contrast agent comprises superparamagnetic iron oxide (SPIO) nanoparticles; performing an initial imaging of a region of interest using delta relaxation enhanced magnetic resonance (DREMR) to obtain positive contrast images due to T1 dispersion of said SPIO nanoparticles correlated with macrophage density to define a functional section; performing selective analysis on the functional section; and following and/or during therapy, performing further imaging of said region of interest one or more times using DREMR to obtain positive contrast images due to T1 dispersion of said SPIO nanoparticles correlated with macrophage density for assessing immune response of said soft tissue to therapy. REJECTION The Examiner rejects: (i) claims 1–3, 7, 9–11, 13, and 14 under 35 U.S.C. § 103 as being unpatentable over Wolf (US 2009/0004113 A1, published Jan. 1, 2009) in view of Alford (US 2011/0160564 A1, published June 30, 2011), and Cunningham et al., “Positive Contrast Magnetic Resonance Imaging of Cells Appeal 2020-001996 Application 15/534,037 3 Labeled with Magnetic Nanoparticles,” Magnetic Resonance in Medicine, vol. 53, pp. 999–1005 (2005) (hereafter “Cunningham”); (ii) claims 4 and 8 under 35 U.S.C. § 103 as being unpatentable over Wolf in view of Alford, Cunningham, and Miyazaki (US 2010/0198053 A1, published Aug. 5, 2010); (iii) claim 5 under 35 U.S.C. § 103 as being unpatentable over Wolf in view of Alford, Cunningham, and “Tests used on biopsy and cytology specimens to diagnose cancer,” published by The American Cancer Society, July 30, 2015 (hereafter “ACS”); and (iv) claim 6 under 35 U.S.C. § 103 as being unpatentable over Wolf in view of Alford, Cunningham, and Pavlopoulou et al., “Human cancer databases (Review),” Oncol. Rep. 2015 Jan; 33(1); 3–18 (hereafter “Pavlopoulou”). For Rejection (i) above, and for all succeeding rejections, the Examiner withdraws alternative rejections that rely on, instead of Cunningham, references referred to as Lin and Gharagouzloo. Ans. 4. ANALYSIS Claims 1–3, 7, 9–11, 13, and 14--§ 103--Wolf/Alford/Cunningham The Examiner combines the teachings of Wolf and Alford, resulting in a method that corresponds to all steps recited in claim 1, with the exception of using superparamagnetic iron oxide (SPIO) as a contrast agent to obtain positive contrast images due to T1 dispersion of the SPIOs. Final Act. 5. The Examiner relies on Lin as disclosing “a new method for imaging cells labeled with SPIO agents with positive contrast,” and concludes that it would have been obvious in view thereof to further modify the method resulting from the combination of Wolf and Alford to acquire positive Appeal 2020-001996 Application 15/534,037 4 contrast images via SPIO-based contrast agents, as opposed to negative contrast images, due to disadvantages associated with using negative contrast images identified in Cunningham. Id. at 5–6. The Examiner additionally points out that Cunningham expressly discloses that it was known to be possible to achieve positive contrast with SPIOs by employing T1 weighting. Ans. 15–16. Appellant does not appear to assign error to the Examiner’s conclusion that it would have been obvious to combine the teachings of Wolf, Alford, and Cunningham. See generally Appeal Br. Instead, Appellant’s arguments devolve to the assertion that “none of the cited references disclose or suggest obtaining positive contrast images due to T1 dispersion of SPIOs.” Appeal Br. 7. As to the Examiner’s reliance on Cunningham as providing that teaching, Appellant maintains that Cunningham does not disclose obtaining positive contrast images “due to T1 dispersion.” Id. Appellant characterizes Cunningham as “seek[ing] to provide positive contrast in imaging mechanisms that are centered around the T2*/susceptibility effects of SPIOs (i.e. imaging mechanisms that are conventionally negative contrast, and that have no connection with T1 dispersion.” Id. (emphasis omitted). Appellant provides no specific citation as to where Cunningham discusses using negative contrast imaging mechanisms to somehow produce positive contrasts, but even if there is some discussion of the same, that does not detract from the fact that Cunningham discloses that it was known in the art, prior to the filing of the application on which this appeal is based, that positive contrast could be achieved using SPIOs by employing T1 weighting, as noted by the Examiner. Ans. 15–16, quoting Cunningham Appeal 2020-001996 Application 15/534,037 5 999. Appellant does not explain how this T1 weighting differs from the claimed T1 dispersion. Indeed, Appellant’s Specification indicates that “T1 dispersion” is the inherent material characteristic or property of having a T1 relaxation time that is a strong function of magnetic field strength. Spec. 7, ll. 1–3. Claim 1 does not recite any specific manner in which the T1 dispersion property is exploited to achieve positive contrast imaging. Appellant’s Specification additionally includes the statement that “[i]t is well known, however not yet exploited, that the T1 relaxation time of iron oxide based contrast agents also varies with the strength of the magnetic field.” Id. at ll. 16–18. In other words, Appellant acknowledges that it was well known that SPIO materials will exhibit T1 dispersion when exposed to magnetic fields of varying strength. The Cunningham disclosure that the T1 characteristic may be used to obtain positive contrast imaging with SPIOs suggests that Appellant may not have been fully aware that this inherent property had either actually been exploited, contrary to the statement in the Specification, or that it was at least an expected and predictable result to be able to use that characteristic to achieve positive contrast imaging. Accordingly, we are not persuaded that the Examiner’s combination of the teachings of Wolf, Alford, and Cunningham fails to disclose, suggest, or render obvious the subject matter of claim 1. The rejection is sustained as to claim 1. For dependent claims 2, 3, 7, 9–11, 13, and 14 subject to this rejection, Appellant expressly relies on the dependency of these claims from claim 1 for the asserted patentability thereof. Appeal Br. 7. The rejection is sustained as to these claims as well. Appeal 2020-001996 Application 15/534,037 6 Claims 4 and 8--§ 103--Wolf/Alford/Cunningham/Miyazaki Claim 5--§ 103--Wolf/Alford/Cunningham/ACS Claim 6--§ 103--Wolf/Alford/Cunningham/Pavlopoulou For these rejections, Appellant does not provide additional argument, and expressly relies on the dependency of these claims from claim 1 for the asserted patentability thereof. Appeal Br. 7. Because we sustain the rejection of claim 1 as being unpatentable, as addressed above, we sustain these rejections as well. DECISION The rejections of claims 1–11, 13, and 14 under 35 U.S.C. § 103, are affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 7, 9– 11, 13, 14 103 Wolf, Alford, Cunningham 1–3, 7, 9–11, 13, 14 4, 8 103 Wolf, Alford, Cunningham, Miyazaki 4, 8 5 103 Wolf, Alford, Cunningham, ACS 5 6 103 Wolf, Alford, Cunningham, Pavlopoulou 6 Overall Outcome 1–11, 13, 14 Appeal 2020-001996 Application 15/534,037 7 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