Ex Parte Courtney et alDownload PDFPatent Trial and Appeal BoardMar 23, 201712162444 (P.T.A.B. Mar. 23, 2017) 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. 12/162,444 11/12/2008 Patrick Courtney 920602-107942 mi 23644 7590 03/27/2017 Barnes & Thornburg LLP (CH) P.O. Box 2786 Chicago, IL 60690-2786 EXAMINER SHEN, BIN ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 03/27/2017 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): Patent-ch@btlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PATRICK COURTNEY and ALISTAIR FITCH Appeal 2015-0066301 Application 12/162,444 Technology Center 1600 Before RICHARD M. LEBOVITZ, JOHN G. NEW and TIMOTHY G. MAJORS, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This appeal involves claims directed a method of modifying a biological sample comprising a mixed population of cells by enriching the sample with respect to cells of interest. The Examiner rejected the claims as anticipated under 35 U.S.C. § 102. We have jurisdiction under 35 U.S.C. §134. The rejection is affirmed. 1 The Appeal Brief (“Appeal Br.”) 2 lists PerkinElmer Singapore PTE Ltd., as the real-party-in-interest. Appeal 2015-006630 Application 12/162,444 STATEMENT OF CASE Appellants appeal from the Examiner’s final rejection of claims 1—4, 6—15, 17, and 18 as anticipated by Palsson (U.S. Pat. No. 6,514,722 B2, pat. Feb. 4, 2003). Final Rejection (“Final Rej.”) 2 Claim 1, the only independent on appeal, reads as follows: 1. A method of modifying a biological sample comprising a mixed population of cells by enriching the sample with respect to cells of interest, comprising the steps of: (a) providing a sample comprising a plurality of cells which include a photosensitive compound that can be induced by light irradiation to inactivate or kill at least part of the respective cell; (b) acquiring a time sequence of images of the plurality of cells; (c) identifying cells of interest in the sample images from said plurality of cells by analysis of the sequence of images acquired in step (b) by an image processing arrangement, the identification of cells of interest being based on detection of a predetermined event involving those cells; (d) selecting cells from said plurality of cells other than the cells identified in step (c); and (e) irradiating only those cells selected in step (d) by directing a light beam to particular locations to induce the photosensitive compound therein to inactivate or kill at least part of those cells, and to enrich the sample with respect to the cells of interest for further analysis. REJECTION The Examiner rejected the claims as anticipated by Palsson. Appellants did not argue the claims separately. Consequently, the claims stand or fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). Below, each step of 2 Appeal 2015-006630 Application 12/162,444 the claim is listed followed by the anticipatory disclosure of Palsson as summarized in the pertinent findings of fact (“FF”). (a) providing a sample comprising a plurality of cells which include a photosensitive compound that can be induced by light irradiation to inactivate or kill at least part of the respective cell; FF1 This invention provides a high-speed method and apparatus for selectively identifying, and individually targeting with an energy beam, specific cells within a cell population for the purpose of inducing a response in the targeted cells. Using the apparatus of the present invention, every detectable target cell in a cell population can be specifically identified and targeted, without substantially affecting cells that are not being targeted. The cells can be a mixed population or of a homogenous origin. Palsson, col. 4,11. 59—67. FF2 A patient with a B cell-derived metastatic tumor in need of an autologous HSC transplant is identified by a physician. As a first step in the treatment, the patient undergoes a standard HSC harvest procedure, resulting in collection of approximately lxlO10 hematopoietic cells with an unknown number of contaminating tumor cells. Id., col. 18,11. 10-16. FF3 This invention provides a high-speed method and apparatus for selectively identifying, and individually targeting with an energy beam, specific cells within a cell population for the purpose of inducing a response in the targeted cells. Id., col. 4,11. 59—62 (see FF1 above) (emphasis added). FF4 The nature of the response that is induced by the energy beam is dependent upon the nature of the energy beam. The response 3 Appeal 2015-006630 Application 12/162,444 can be lethal or non-lethal. Thus, examples of responses that can be induced with an energy beam include necrosis, apoptosis, optoporation (to allow entry of a substance that is present in the surrounding medium, including genetic material), cell lysis . . . activation of a photosensitive substance, excitation of fluorescent reagent, photobleaching, and molecular uncaging. Id., col. 5,11. 20-30 (emphasis added). FF5 Although this embodiment describes the killing of cells via thermal heating by the energy beam, one skilled in the art would recognize that other responses can also be induced in the cells by an energy beam, including photomechanical disruption, photodissociation, photoablation, and photo chemical reactions, as reviewed by Niemz (Niemz 1996). For example, a photosensitive substance (e.g., hemtoporphyrin derivative, tin- etiopurpurin, lutetuim texaphyrin) (Oleinick and Evans 1998) within the cell mixture could be specifically activated in targeted cells by irradiation. Id., col. 12,11. 16-25. Palsson teaches “providing a sample comprising a plurality of cells” (FF1, FF2). Palsson describes “includ[ing] a photosensitive compound that can be induced by light irradiation to inactivate or kill at least part of the respective cell,” where an energy beam is used to selectively target cells and they have been identified (FF3) and where photosensitive compounds can be used to kill the cells (FF4, FF5). (b) acquiring a time sequence of images of the plurality of cells; (c) identifying cells of interest in the sample images from said plurality of cells by analysis of the sequence of images acquired in step (b) by an image processing arrangement, the identification of cells of interest being based on detection of a predetermined event involving those cells; 4 Appeal 2015-006630 Application 12/162,444 FF6 In addition to the illumination laser 305, an optional treatment laser 400 is present to irradiate the targeted cells once they have been identified by image analysis. Of course, in one embodiment, the treatment induces necrosis of targeted cells within the cell population. Palsson, col. 10,11. 56—60 (emphasis added). FF7 It is readily apparent to one skilled in the art that the single filter 460 could be replaced by a movable filter wheel that would allow different filters to be moved in and out of the optical pathway. In such an embodiment, images of different wavelengths of light could be captured at different times during cell processing, allowing the use of multiple cell labels. Id., col. 13,11. 11—17 (emphasis added). Palsson teaches “identifying cells of interest” by image analysis (FF6), and that such images utilized in the analysis can be collected at different time intervals (“a time sequence of images of the plurality of cells”) (FF7) as required by step (b) of the claim. The “predetermined events” of step (c) reads on the image or morphology of the imaged cell. Final Rej. 3. (d) selecting cells from said plurality of cells other than the cells identified in step (c); (e) irradiating only those cells selected in step (d) by directing a light beam to particular locations to induce the photosensitive compound therein to inactivate or kill at least part of those cells, and to enrich the sample with respect to the cells of interest for further analysis. 5 Appeal 2015-006630 Application 12/162,444 FF8 The cells targeted can be labeled as is often the case when the specimen is a mixed population . . . Generally, the method first employs a label that acts as a marker to identify and locate individual cells of a first population of cells within a cell mixture that is comprised of the first population of cells and a second population of cells. The cells targeted by the apparatus and methods herein are those that are selectively labeled, in the case of a mixed population of cells, or the ones undergoing interrogation or intersection by the illumination source or energy beam. Palsson, col. 7,11. 27-42. FF9 ft should be noted that if no specific label is available for cells of the first population, the method can be implemented in an inverse fashion by utilizing a specific label for cells of the second population. For example, in hematopoietic cell populations, the CD34 or ACC-133 cell markers can be used to label only the primitive hematopoietic cells, but not the other cells within the mixture. In this embodiment, cells of the first population are identified by the absence of the label, and are thereby targeted by the energy beam. Id., col. 8,11. 5—13 (emphasis added). In steps (b) and (c) of claim 1, cells are identified from a time sequence of images (FF7). Palsson also teaches that cells not labeled can be selected and irradiated as in step (e) of claim 1 (FF9). Thus, Palsson teaches that cells which are not labeled in the time sequence (FF7) (“other than the cells identified in step (c)”) can be selected as required by step (d) of claim 1 and then irradiated as in step (e) (FF8, FF9). 6 Appeal 2015-006630 Application 12/162,444 Discussion Appellants contend that “Palsson does not disclose the irradiation of cells selected based upon identification of cells of interest from a time sequence of images of the original sample of cells as required in claim 1 Appeal Br. 12. Specifically, Appellants contend that the Examiner’s reference to Example 11 as teaching “acquiring a time sequence of images of the plurality of cells” is an error because in the example the time-lapse images are acquired after the step of irradiating in contrast to the order required by the claims. Id., 11—12 (compare steps (e) and (b)). See also Reply Br. 3. We agree with Appellants that Example 11 does not describe the order of steps required by claim 1. However, in addition to Example 11, the Examiner also cited the disclosure at column 13, line 14++ of Palsson (Ans. 4, 6) which describes capturing a sequence of images at different times during cell processing to allow the use of multiple labels (FF7). Such image analysis is performed for the purpose of identifying cells which are to be irradiated, including to kill (necrosis) cells (FF6). In addition to teaching a time-sequence of images (FF7), Palsson also teaches that the first population to be targeted with the energy beam can be identified by the absence of the label (FF9). Thus, if the time sequence described by Palsson (FF7) is used to identify a second population of cells which is to be spared (e.g., if the second population are the HSC cells of Palsson’s Example 1 (FF2)) by distinguishing it from other populations of cells in the mixture, then step (d) and (e) of claims 1 are met because then the unlabeled cells would be irradiated (FF9). 7 Appeal 2015-006630 Application 12/162,444 There is adequate evidence to establish that Palsson describes every step of the claimed invention “arranged as in the claim.” Net Money IN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). Palsson describes identifying cells by image analysis (FF6), and specifically teaches time sequence capture (step (b)) as an alternative to single image capture (FF7). Palsson also teaches targeting cells which are unlabeled and not captured by the image analysis of steps (d) and (e) (FF9). Thus, there are only a few envisageable alternatives: performing a time-sequence or collecting only one image; and irradiating labeled or unlabeled cells. Anticipation can be established when a small genus is disclosed and each member can be at once envisaged. In re Petering, 301 F.2d 676, 681 (CCPA 1962). Even if choices are to be made, such choices do not disqualify the disclosure from being anticipatory. In Wm. Wrigley Jr. Co. v. Cadbury Adams USALLC, 683 F.3d 1356, 1361-62 (Fed. Cir. 2012) For the foregoing reasons, the anticipation rejection is affirmed. TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 8 Copy with citationCopy as parenthetical citation