Alan HoweDownload PDFPatent Trials and Appeals BoardMar 2, 202011901875 - (D) (P.T.A.B. Mar. 2, 2020) 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. 11/901,875 09/19/2007 Alan Howe 421/73/3 DIV 8043 25297 7590 03/02/2020 Jenkins, Wilson, Taylor & Hunt, P.A. 3015 Carrington Mill Boulevard Suite 550 Morrisville, NC 27560 EXAMINER RAWLINGS, STEPHEN L ART UNIT PAPER NUMBER 1643 NOTIFICATION DATE DELIVERY MODE 03/02/2020 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): datcheson@jwth.com usptomail@jwth.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ALAN HOWE Appeal 2018-006764 Application 11/901,875 Technology Center 1600 Before DONALD E. ADAMS, FRANCISCO C. PRATS, and JOHN E. SCHNEIDER Administrative Patent Judges. SCHNEIDER, 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 15–18 and 23–26. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as the University of North Carolina at Chapel Hill. Appeal Br. 1. Appeal 2018-006764 Application 11/901,875 2 CLAIMED SUBJECT MATTER The claims are directed to a kit for detecting phosphoproteins. Claim 15, reproduced below, is illustrative of the claimed subject matter: 15. A kit comprising: (a) a phosphoprotein detection reagent (PPDR) comprising: (i) a polydentate chelator that coordinates a Zn2+ ion; (ii) a detectable moiety conjugated to the polydentate chelator, wherein when the Zn2+ ion is coordinated to the chelator, a chelator-metal ion moiety is formed that can selectively bind to a phosphorylated amino acid residue in a phosphoprotein to create a chelator-metal-ion- phosphoprotein (CMPP) complex, and the detectable moiety allows the CMPP complex to be detected; and (iii) a Zn2+ ion, (b) a membrane; (c) a carboxy-blocking reagent; and (d) instructions for using the PPDR. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Patton, et al. US 7,550,271 B2 June 23, 2009 Kinoshita-Kikuta, et al., Enrichment of phosphorylated proteins from cell lysate using novel phosphate-affinity chromatography at physiological pH, 6 Proteomics 5088–5095 (2006) Ficarro et al., Phosphoproteome analysis by mass spectrometry and its application to Saccharomyces cerevisiae, 20 Nature Biotech 301–305 (2002) Appeal 2018-006764 Application 11/901,875 3 REJECTIONS The Examiner has rejected claims 15–18 and 23–262 as follows: Claims 15–18 and 23–26 have been rejected under pre-AIA 35 U.S.C. § 112, first paragraph for failure to comply with the written description requirement. Claims 15–18 and 23–26 have been rejected under pre-AIA 35 U.S.C. § 112, first paragraph for failure to comply with the enablement requirement. Claims 15–18 and 23–26 have been rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Patton combined with Kinoshita-Kukuta and Ficarro. OPINION I – Written Description A. Issue The issue with respect to this rejection is whether the Examiner correctly determined that the claims fail to satisfy the written description requirement. The Examiner finds that the pending claims do not comply with the written description requirement. Non-Final Act. 12. The Examiner finds that the term “polydentate chelator” that coordinates with Zn2+ is not supported by the present Specification. Id. The Examiner finds that the term “polydentate chelator” embraces a wide variety of compounds which may have substantially different structures. Id. The Examiner goes on to find that although the Specification gives some examples of polydentate 2 Claims 10, 11, 13, and 14 are also pending in the application but have been withdrawn from consideration. Non-Final Act. 2 Appeal 2018-006764 Application 11/901,875 4 chelators, they are not representative of the entire class of compounds which falls within the term. Id. at 12–13. The Examiner finds the term “polydentate chelator” that binds to Zn2+ is a functional description and does not provide an adequate description of the claimed genus. Id at 13. The Examiner also finds that the Specification does not provide adequate written description for the term phosphoprotein detection reagent in that the Specification does not provide examples of complexes which bind to protein containing phosphothreonine or phosphotryosine. Id. at 14. The Examiner concludes, the disclosure describing the claimed subject matter fails to adequately described that subject matter with the requisite clarity and particularity to reasonably convey to the skilled artisan Applicant’s possession thereof as of the filing date of the application, so as satisfy the written description requirement set forth under 35 U.S.C. § 112, first paragraph. Id. at 18. Appellant contends that the Specification contains an adequate description of the claimed invention. Appeal Br. 4–14. Appellant contends that the term polydentate chelator is fully defined in the Specification and that at least eleven different examples of polydentate chelators are recited in the Specification. Id. at 7–8. Appellant contends that one skilled in the art would understand which chelators would be able to coordinate with Zn2+ and would appreciate that Appellant had the claimed invention is its possession. Id. at 9–11. In support of this contention, Appellant offers the Declaration of the inventor, Dr. Howe.3 Id. at 9. Dr. Howe testifies that the term 3 Declaration Pursuant to 37 C.F.R. § 1.132, filed December 19, 2016(“Howe Decl.”). Appeal 2018-006764 Application 11/901,875 5 polydentate chelator was well-known in the art and that the art recognized that there were polydentate chelators that bind to Zn2+. Howe Decl. ¶¶ 9–10. With respect to the issue of binding to phosphoproteins, Appellant contends that the Specification provides an adequate description as to why one skilled in the art would expect the disclosed complexes to phosphorylated amino acids in addition to phosphoserine. Appeal Br. 13– 14. B. Legal Principles “[W]hile the description requirement does not demand any particular form of disclosure, or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en banc) (citations omitted). “[T]he test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Id. at 1351. A “sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. at 1350. “The written description requirement requires possession as shown in the specification, not as shown by prior experimental work.” Allergan, Inc. Appeal 2018-006764 Application 11/901,875 6 v. Sandoz Inc., 796 F.3d 1293, 1309 (Fed. Cir. 2015) (emphasis in the original). C. Analysis We have considered the positons of the Examiner and Appellant and find that the Examiner has the better position. The Specification does not contain an adequate written description of the claimed invention, particularly it does not describe a polydentate chelator which coordinates with a zinc cation so as to selectively bind to a phosphorylated amino acid residue in a phosphoprotein. Although the Specification describes polydentate chelators in general, lists metals that may be used in the practice of the inventions, and gives examples of polydentate chelators, Appellant points to nothing in the Specification where a polydentate chelator that coordinates with a zinc cation is described. See Spec. 20–21. In addition, there is no description of any specific polydentate chelator-zinc complex which binds to a phosphorylated amino acid. Appellant contends that one skilled in the art would understand from reading the Specification that zinc can be used to prepare the polydentate/metal complex. Appeal Br. 6–8. Appellant also points to evidence that zinc chelator complexes were known in the art. Id. at 8–10. These arguments are unpersuasive. Although it may have been obvious to one skilled in the art, following the teachings of the Specification to use a zinc cation, this does not mean that there is an adequate written description of zinc containing chelator complexes. Ariad, 598 F.3d at 1352. Similarly, although zinc containing chelator complexes may have been Appeal 2018-006764 Application 11/901,875 7 known in the art at the time the invention was made, that is insufficient to comply with the written description requirement. Allergan, 796 F.3d at 1309. Appellant contends that the Specification contains an adequate written description as the disclosure contains a listing of at least eleven different polydentate chelators. Appeal Br. 8. Appellant contends that based on the disclosure of these chelators and the general description of chelators in the Specification, one skilled in the art would understand that nature and structure of the chelator molecules that can be used to practice the invention. Id. Again, we are not persuaded by this argument. As the Examiner points out, although the Specification does list some examples of chelators which may work, “there is no correlation between any one particularly identifying material or structural features that are necessarily shared by at least substantial number of the ‘polydentate chelators’ of which the ‘phosphoprotein detection reagents’ are comprised and their common ability to coordinate Zn2+ so as to selectively bind to phosphorylated amino acid residues in phosphoproteins.” Ans. 24. We agree with the Examiner that that eleven polydentate chelators listed in the Specification can be reasonably regarded as representative of the class of compounds recited in the claims. Id. at 25. Appellant contends that claims 25 and 26 are separately patentable as they recite particular polydentate chelators which are disclosed in the Specification. Appeal Br. 24. Appellant contends that one skilled in the art would have known that zinc can bind to the chelators and that based on the Appeal 2018-006764 Application 11/901,875 8 disclosure in the Specification, one skilled in the art would have been able to practice the invention without undue experimentation. Id. Appellant’s argument does not persuade us that claims 25 and 26 are separately patentable. The issue with respect to the written description requirement is not whether one skilled in the art could practice the invention, but whether one skilled in the art would understand what the inventor has invented. Compliance with the written description requirement must be found within the Specification itself. Although the Specification describes the two specific chelators, Appellant points to nothing in the Specification that discloses the ability of those chelators to coordinate with a zinc cation or the ability of a complex comprising either of the specific chelators with a zinc cation to bind to a phosphorylated amino acid residue in a phosphoprotein. Based on the forgoing we affirm the rejection of claims 15–18 and 23–26 for failure to comply with the written description requirement. II – Enablement A. Issue The issue with respect to this rejection is whether the Examiner has correctly determined that the rejected claims are not enabled. The Examiner finds that although the Specification discloses how to make and use a kit based on a biotinylated nitriloacetic acid (“NTA”) conjugate coordinated with an iron cation to detect a phosphoprotein, the Specification does teach how to make and use a polydentate chelator coordinated with a zinc cation. Non-Final Act. 27. The Examiner finds that Appeal 2018-006764 Application 11/901,875 9 the art, and in particular Chaga4 teaches that chelating agents coordinated with different metals have different binding properties making it difficult to predict how a chelator with a zinc cation substituted for an iron cation might react with a phosphoprotien. Id. at 27–28. The Examiner concludes that the claimed invention cannot be practiced without undue experimentation. Id. at 29. Appellant contends that the rejection is improper in that the Examiner failed to properly consider all of the factors set forth in In re Wands, 858 F.2d 731 (Fed. Cir. 1988). Appeal Br. 19–20. Appellant also contends that one skilled in the art would have been able to substitute a zinc cation for the iron cation in the examples. Id. at 21–22. In support of this proposition, Appellant points to the teachings of Hemdan5 and Nieba6 where it is shown that zinc cations can coordinate with NTA and iminodiacetic acid (“IDA”). Id. at 22–23. B. Legal Principles “Section 112 requires that the patent specification enable those skilled in the art to make and use the full scope of the claimed invention without undue experimentation. . . . [S]ee also In re Goodman, 11 F.3d 1046, 1050 4 Grigoriy S. Chaga, Twenty-five years of immobilized metal ion affinity chromotagraphy: past, present and future, 49 J. Biochem. Biophys. Methods 313–334 (2001) (“Chaga”). 5 Esmat S. Hemdan et al., Surface topography of histidine residues: A facile probe by immobilized metal ion affinity chromatography, 86 Proc. Nat’l Acad. Sci. 1811–1815 (1989) (“Hemdan”). 6 Lars Nieba et al., BIACORE Analysis of Histidine-Tagged Proteins Using a Chelating NTA Sensor Chip, 252 Anal. Biochem. 217–228 (1997) (“Nieba”). Appeal 2018-006764 Application 11/901,875 10 (Fed. Cir. 1993) (‘[T]he specification must teach those of skill in the art how to make and how to use the invention as broadly as it is claimed.’).” Invitrogen Corp. v. Clontech Labs. Inc., 429 F.3d 1052, 1070–71 (Fed. Cir. 2005) (internal quotes omitted). “[A]n invention may be enabled even though it has not been described.” University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 921 (Fed. Cir. 2004). The enablement requirement is often more indulgent than the written description requirement. The specification need not explicitly teach those in the art to make and use the invention; the requirement is satisfied if, given what they already know, the specification teaches those in the art enough that they can make and use the invention without “undue experimentation.” Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334 (Fed. Cir. 2003). Analysis We have considered the arguments advanced by the Examiner and Appellant and conclude that the claims are enabled. Although the Specification only discloses the use of iron cation containing complexes, Appellant has shown that zinc cation analogs were known at the time of the invention. Appeal Br. 22–23. In addition, the Specification describes how the cation complex would interact with the phosphoprotein. See, e.g., Spec., 40, ll. 23–25. We agree with Appellant that given the state of the art at the time the invention was made, one skilled in the art would have been able to Appeal 2018-006764 Application 11/901,875 11 practice the claimed invention without undue experimentation. Appeal Br. 24. The Examiner’s reliance on Chaga to show unpredictability is misplaced. Chaga teaches that hard metal ions such as Fe3+ coordinate with oxygen and that intermediate metal ions such as Zn2+ coordinate with nitrogen, oxygen and sulfur. Chaga, 314. We agree with Appellant that this would lead one skilled in the art to conclude that both Fe3+ and Zn2+ could be used to coordinate with oxygen in the phosphate group. Appeal Br. 21. We conclude that the Examiner has not established that the rejected claims are not enabled. III. Obviousness The Examiner has rejected claims 15–18 and 23–26 as unpatentable over Patton combined with Kinoshita-Kikuta and Ficarro. Appellant contends that the rejection is improper as the present application is a divisional of USSN 10/719,990 which was filed on November 21, 2003, well before the 102(a) or 102(e) dates of the cited references. Appeal Br. 25–26. Appellant contends that the present application and the parent application comply with the enablement and written description requirements of 35 U.S.C. § 112 allowing Appellant to claim benefit 2003 filing date of the parent application. Appeal Br. 25–28. In order to receive benefit of the earlier filing date under §§ 119 and/or 120, the later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application); the disclosure of the invention in the parent application and in the later-filed Appeal 2018-006764 Application 11/901,875 12 application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. § 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551 (Fed. Cir. 1994). As discussed above, we find that the present disclosure does not satisfy the written description requirements of 35 U.S.C. § 112. Because the earlier Specification is identical to the present Specification, it too does not satisfy the written description requirement. For this reason, Appellant’s claim of priority back to 2003 fails giving the present application a filing date of September 19, 2007. Thus the cited references are prior art under 35 U.S.C. §§ 102(a) and 201(e). For this reason we affirm the rejection based on obviousness. CONCLUSION The Examiner’s rejection for failure to comply with the written description requirement is affirmed. The Examiner’s rejection for lack of enablement is reversed The Examiner’s rejection for obviousness is affirmed. Appeal 2018-006764 Application 11/901,875 13 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 15–18, 23– 26 112 Written Description 15–18, 23– 26 15–18, 23– 26 112 Enablement 15–18, 23– 26 15–18, 23– 26 103 Patton, Kinoshita- Kikuta, Ficarro 15–18, 23– 26 Overall Outcome 15–18,23– 26 TIME PERIOD FOR 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 Copy with citationCopy as parenthetical citation