Ex Parte Simon et alDownload PDFPatent Trial and Appeal BoardFeb 27, 201711740014 (P.T.A.B. Feb. 27, 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. 11/740,014 04/25/2007 Bruce Simon 5394.675US1 1361 104326 7590 03/01/2017 Schwegman Lundberg & Woessner / Zimmer P.O. Box 2938 Minneapolis, MN 55402 EXAMINER CORD AS, EMILY ANN ART UNIT PAPER NUMBER 1651 NOTIFICATION DATE DELIVERY MODE 03/01/2017 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): SLW @ blackhillsip.com USPTO@slwip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BRUCE SIMON and JENNIFER E. WOODELL-MAY Appeal 2016-001384 Application 11/740,014 Technology Center 1600 Before DEMETRA J. MILLS, ERIC B. GRIMES, and RICHARD J. SMITH, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a). The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2016-001384 Application 11/740,014 STATEMENT OF CASE According to the Specification, The present technology provides methods for repairing a cartilage defect in a human or animal subject. Such methods include a method for treating a cartilage defect comprising: obtaining blood compatible with the subject; fractionating the blood to produce platelet-poor plasma; concentrating the platelet-poor plasma to produce a platelet-poor plasma concentrate; and administering the concentrate to the site of the cartilage defect. Spec. 13. CLAIMED SUBJECT MATTER The following claim is representative.1 1. A method for treating a cartilage defect in a human subject comprising: obtaining blood compatible with the subject; fractionating said blood to produce platelet-poor plasma; concentrating said platelet-poor plasma by about 1.5 to 3 times to produce a platelet-poor plasma concentrate; and administering said concentrate to the site of said cartilage defect, wherein platelet rich plasma is not administered to the site of said cartilage defect. 1 Claims 1—16, 25, and 27—32 are currently pending. Claims 7—10 and 13 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. Claims 17—24 and 26 are cancelled. The text of additional pending claims may be found in the Appendix to the Brief. 2 Appeal 2016-001384 Application 11/740,014 Grounds of Rejection 1. Claims 1, 2, 4—6, 11, 12, 14, 16, 25, 27—29, 31, and 32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Binette et. al. (US 2005/0038520 Al; Feb. 17, 2005) (“Binette”) in view of Brandt et al. (US 6,649,072 B2; Nov. 18, 2003) (“Brandt”) in light of Bonnie Wright, Management of chronic soft tissue pain, Topics in Companion Animal Medicine, Vol. 25, No. 1, pp. 26—31 (2010). (“Wright”). 2. Claims 1—6, 11, 12, 14—16, 25, and 27—32 are rejected under pre- AIA 35 U.S.C. 103(a) as being unpatentable over Binette in view of Brandt, Wright, and S. Mariovits, A New Simplified Technique for producing platelet-rich plasma: a short technical note, 13 Eur. Spine J. (Suppl. I), SI02—SI06 (2004) (“Mariovits”) or Leach et al. (US 2005/0109716 Al; May 26, 2005) (“Leach”). FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Final Action at pages 2—13. The following facts are highlighted. 1. According to the Specification, the platelet poor plasma (PPP) may optionally include “adjunct therapeutic materials such as platelet activators or other bioactive agents, scaffolds, buffers, isolated tissue materials and combinations thereof.” |22, emphasis added. 2. “Platelet activators among those useful herein include thrombin, calcium chloride (CaCT), coagulation factors, and mixtures thereof. Coagulation factors include, but are not limited to, one or 3 Appeal 2016-001384 Application 11/740,014 more of the following: V, VII, Vila, IX, IXab, X, Xa, XI, XIa, XII, a-XIIa, P-XIIa, and XIII.” |27, emphasis added. PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Rejection 1 Claim 1 The Examiner finds that Binette teaches a “method of cartilage repair comprising of the application of a gel comprising of platelet poor plasma clot to the site of the cartilage defect (abstract, 0019 and 0039). The composition does not need to include PRP (para. 39).” Final Act. 4. Binette further teaches that, “PPP ... [is] an anchoring agent for a biological component on the tissue repair implants (0069-0070) to be administered to the site of the cartilage defect (abstract and 0063).” Ans. 14. The Examiner relies on Brandt for a suggestion of the claimed platelet-poor plasma concentrate. Final Act. 7. In particular, the Examiner finds that Brandt teaches concentrating the PPP to 5/6 the original volume in (Col.2 lines 27-35) and that the volume is reduced to about 5/6 (Col. 2 lines 4 Appeal 2016-001384 Application 11/740,014 58-59) .... [A]t the time of the claimed invention, it would have been obvious to optimize the concentration of the PPP according to specific application. First, the use of the term “about“ without definition [in claim 1] permits an undefined range below and above the lowest and highest points of the range. Thus, about 1.5 can be interpreted to include 1.2 as applicants urge the reference teaches. Second, it is well settled that differences in concentration are not sufficient to overcome an obviousness rejection unless such concentration is critical. Id. Appellants contend that a PPP clot is not PPP; nor is it a PPP concentrate. It is generally known to those of ordinary skill in the art that fibrinogen-rich plasma, e.g., PPP, when combined with a source of thrombin and calcium, sets in motion a cascade of biochemical reactions that ultimately produce a PPP clot. See, Marlovits, Discussion at page SI04. Because the physical nature and character, e.g., the biological and chemical constituents of the PPP clot and the PPP starting material are fundamentally different, one of ordinary skill in the art would not reasonably understand Binette's teaching regarding a PPP clot to be a teaching that PPP, in and of itself, may be used as a tissue scaffold (see Binette at 1038). Reply Br. 5. Appellants further argue that, “Brandt does not teach a PPP concentrate is administered to a subject to facilitate soft tissue repair, as asserted by the Examiner.” Id. ANALYSIS Claims which have been argued separately in the brief are addressed individually. Otherwise, we select claim 1 as representative claim. We agree with the Examiner’s fact finding, statement of the rejection and responses to 5 Appeal 2016-001384 Application 11/740,014 Appellants’ arguments as set forth in the Answer. We find that the Examiner has provided a preponderance of evidence to support a prima facie case of obviousness. We provide the following additional comment to the Examiner’s argument set forth in the Final Rejection and Answer. Appellants argue that a PPP clot is not a PPP concentrate, as claimed. Reply Br. 5. We are not persuaded by Appellants’ arguments. First, Appellants’ claims are open to other elements due to the transitional claim language “comprising.” “‘Comprising’ is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.” Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). Furthermore, according to the Specification, optional ingredients, including platelet activators (thrombin and calcium), may be added to the PPP and are within the scope of the claim. FF 1,2. Therefore, PPP with added thrombin and/or calcium to form a PPP clot, is within the scope of claim 1. Moreover, PPP itself may be administered to repair cartilage tissue injuries, according to Binette, 170. Appellants argue that Brandt teaches that platelet poor plasma concentrate and platelet rich plasma are combined to result in a composition that is rich in platelets for bone fusion or tissue repair, and therefore teaches away from the use and administration of PPP alone, as claimed. App. Br. 12. Appellants argue that Brandt does not teach a PPP concentrate is administered to a subject to facilitate soft tissue repair. Reply Br. 5. We are not convinced by these arguments. We agree with the Examiner that 6 Appeal 2016-001384 Application 11/740,014 Binette clearly teaches a method of cartilage repair comprising of the application of a gel comprising of PPP clot to the site of the cartilage defect (abstract, 0019 and 0039) and PPP as an anchoring agent for a biological component on the tissue repair implants (0069-0070) to be administered to the site of the cartilage defect (abstract and 0063). Ans. 14. Brandt is only relied upon to evidence that concentrating PPP (in a manner consistent with the instant invention) and treating cartilage defects with concentrated PPP was known at the time of the invention. Id. Binette is relied on for the application of a gel comprising a PPP clot alone to the site of the cartilage defect. Ans. 14. Thus, we agree with the Examiner that it would have been obvious to one of ordinary skill in the art to prepare the PPP concentrate as in Brandt, and use it in a method of treating a cartilage defect by administering PPP as taught by Binette, because Brandt teaches that, “concentrating the original PPP component provides a more tenacious coagulum that is helpful in bonding together various bone fragments or bone fusion products, in providing a tighter matrix or scaffold for enticing the migration of osteoblasts and for the enhancement of hemostasis.“ Brandt, col. 2,11. 41^16; Ans. 15. Furthermore, Appellants have not shown that the 1.2 times PPP concentrate of Brandt does not fall within the scope of the claimed platelet- poor plasma concentrate of about 1.5 to 3 times, as claimed. To show criticality of the claimed concentration range, ‘“it is not inventive to discover the optimum or workable ranges by routine experimentation. ’ In re Aller, 220 F.2d 454, 456 (CCPA 1955). In addition, such broadening usage of the term “about” as in claim 1 (with respect to the PPP concentration), “must be given reasonable scope; they must be viewed by the decision maker as they would be understood by persons experienced in the field of 7 Appeal 2016-001384 Application 11/740,014 the invention. Although it is rarely feasible to attach a precise limit to ‘about,’ the usage can usually be understood in light of the technology embodied in the invention.” Modine Manufacturing Co. v. U.S. ITC, 75 F.3d 1545, 1554 (Fed. Cir. 1996). Claim 27 Appellants argue that, “Claim 27 and its dependent claims preclude the use of a scaffold material or of a tissue material.” App. Br. 15, Reply Br. 9—10. However, we agree with the Examiner that “consists essentially of’ [in Claim 27] limits the scope of the steps of the method and does not further limit or exclude anything from the PPP composition. In addition, the transitional phrase “consisting essentially of’ limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention and has a different meaning from the transitional phrase, “consisting of’, see MPEP 2111.03 Furthermore, there is no clear indication in the specification or the claims what the basic and novel characteristics actually are or what is critical and/or would materially affect the invention. For instance, there is no discussion how the presence of PRP would change it, but that the composition can include platelet- rich plasma as an adjunct therapeutic material (0023 and 0034 of published application) and that scaffolds can be used to contain, support, or retain the therapeutic composition (0028 of published application). The specification offers no examples or advantages of concentrated PPP in treating cartilage defects. Accordingly, it is not clear what steps would not materially affect the basic and novel characteristics of the claimed invention. Ans. 19—20. We further find that the evidence before us shows that scaffolds do not materially affect the basic and novel characteristics of the 8 Appeal 2016-001384 Application 11/740,014 claimed invention, as evidenced by FF 1 and 2, and pending claim 5. Additional arguments of Appellants have been addressed fully in the Answer.2 Rejection 1 is affirmed for the reasons of record. Rejection 2 With respect to rejection 2, Marlovits and Leach are relied on for the use of a tube with one or two buoys to fractionate blood into PPP, PRP and red blood cells. Final Act. 12. See, pending claims 3,13 and 30. Appellants argue that, “nothing in these references overcomes the fundamental fact that Brandt requires the use of platelet rich plasma in order to make a therapeutic composition, in direct contravention of Appellants' claims.” App. Br. 17. Having found no deficiencies in the rejection based on Binette and Brandt, we also affirm rejection 2. CONCLUSION OF LAW The cited references support the Examiner’s obviousness rejections, which are affirmed for the reasons of record. All pending, rejected claims fall. Arguments not made, or timely made, are waived. 2 The Reply Brief presents arguments for the first time with respect to claims 14 and 25. “(2) Any argument raised in the reply brief which was not raised in the appeal brief, or is not responsive to an argument raised in the examiner's answer, including any designated new ground of rejection, will not be considered by the Board for purposes of the present appeal, unless good cause is shown.” 37 C.F.R. 41.41(b)(2). See also, 37 C.F.R. 41,37(c)(iv): “A statement which merely points out what a claim recites will not be considered an argument for separate patentability of the claim.” 9 Appeal 2016-001384 Application 11/740,014 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)(l)(iv). AFFIRMED 10 Copy with citationCopy as parenthetical citation