This continuing legal education (CLE) presentation covers new developments in patent law. In particular, the presentation provides an overview of 35 USC § 112, first paragraph, written description and enablement case law and describes how functional claim language in patents is treated by that case law. In addition, the presentation focuses on how the Federal Circuit treated functional claim language in a recent en banc case, Ariad v Lilly (Fed. Cir. 2010) and how the Board of Patent Appeals and Interferences has recently treated functional claim language in a series of recent cases citing to the precedential case, Ex Parte Miyazaki (BPAI 2008).

1. Functional Claim Language After the ARIAD V. LILLY Reaffirmance of the Lilly Written Description Requirement By Ronald Ward June 25, 2010 © 2010 Workman | Nydegger

2. Disclaimer These materials are public information and have been prepared solely for educational purposes to contribute to the understanding of American intellectual property law. These materials reflect only the personal views of the author and are not individualized legal advice. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the author and Workman Nydegger, P.C.. cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the author or Workman Nydegger, P.C. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.

3. Agenda Overview of 35 USC § 112 ¶ 1 and the “Lilly” Written Description Doctrine Review Ariad v. Lilly (2010) (en banc)Fed. Cir. Decision Survey of Recent “Scope of Enablement” Rejections at BPAI Take-Aways

4. 35 USC 112 First ¶ “The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the same . . .”

5. Traditional Written Description Doctrine The traditional written description requirement polices priority or “new matter” violations. Until 1997, original claims were treated as having written description support. But see In re DiLeone, 436 F.2d 1404 (CCPA 1971) (asserting the possibility that a specification could enablethe use and practice of a broadly claimed invention and still not describethe invention)

6. “Lilly” Written Description Doctrine of 1997 In Regents of the University of California v. Eli Lilly & Company, 119 F. 3d 1559 (1997) the Fed. Cir. stated: In Lilly, a description of rat insulin DNA and the human insulin protein, did not support an ORIGINAL claim to the human insulin DNA. “An adequate written description of a DNA…requires a precise definition, such as by structure, formula, chemical name or physical properties.”

7. “Lilly” Written Description Doctrine of 1997 The “Lilly” Written Description (LWD) doctrine has been criticized as confusing, redundant with enablement, and conflicting with claim construction case law, which permits broad claims. For example, in Lizardtech v. Earth Resource Mapping, 433 F.3d 1373, 1380 (2006) Rader, dissenting from denial of rehearing en banc, stated: “In 1997, when this court strayed from the statute (Section 112) and modified the written description requirement, it created the present confusion.”

8. Ariad v. Lilly (2010) Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d. 1336, 1349 (Fed. Cir. 2010)(en banc) reaffirmed the LWD Doctrine: Despite a description of molecules that could hypothetically reduce NF-kB activity (to reduce symptoms of certain diseases), the specification did not support an ORIGINAL genus claim to methods of inhibiting NF-kB activity. “We now reaffirm that § 112, first paragraph, contains a written description requirement separate from enablement….”

9. Ariad v. Lilly (2010) Rader and Linn dissented vociferously: Rader also argued that the LWD doctrine is confusing, lacks statutory support, conflicts with rules for claim construction and blocking patents. Moreover, enablement effectively polices functional language. Linn also argued that the LWD doctrine is indistinguishable from the requirements for enablement. “As it stands, the court’s inadequate description of its written description requirement acts as a wildcard on which the court may rely when it faces a patent that it feels as unworthy of protection.”

10. Ariad v. Lilly (2010) The LWD doctrine has been and will continue to be applied mainly to chemical and biological arts: “Perhaps there is little difference in some fields between describing an invention and enabling one to make and use it, but that is not always true of certain inventions, including chemical and chemical-like inventions. … The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function—a problem that is particularly acute in the biological arts..”

11. Ariad v. Lilly (2010) However, nothing inherently limits LWD doctrine to chemical and biological arts: “[The court’s written description doctrine] has not just been applied to chemical and biological inventions. See LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1343-47 (Fed. Cir. 2005).”

12. “Lilly” Written Description Doctrine of 2010+ Does the USPTO view the LWD doctrine as being mostly limited to chemical and biological arts? Kappos’ blog post of May 5, 2010, comments favorably on Ariad, stating: “The Ariaddecision is important…because written description is a critical tool for ensuring that an applicant does not claim more than she is entitled to claim… And the written description doctrine is particularly useful in examining claims that employ functional language…. I…strongly support our examiners using the written description requirement to prevent issuance of such vastly overbroad recitations.”

13. “Lilly” Written Description Doctrine of 2010+ Ariad majority expresses policy concerns with functional language, stating: Dissent’s response: “The problem [of demonstrating that the applicant has invented species sufficient to support a claim to a genus] is especially acute with genus claims that use functional language… [T]he functional claim may simply claim a desired result, and may do so without describing species that achieve that result.” “I agree that such claims should be invalid—but enablement polices those claims effectively.”

14. Does Enablement Effectively Police Functional Language? Ex parte Miyazaki, 89 USPQ2d1207 (BPAI 2008) (precedential) is the real wildcard. A “sheet feeding area” was deemed beyond the scope of what was enabled in the specification. 26. A large printer comprising: a sheet feeding area operable to feed a plurality of paper rolls ranging in width from 210 mm to 1120 mm, a substantially flat sheet of paper ranging in length from 420 mm to 1580 mm and at least one stiff carton ranging in length from 420 mm to 730 mm.

17. “Scope of Enablement” Rejections at BPAI Ex parte Rodriguez (BPAI 2009) (precedential) 1. An apparatus comprising: a system configuration generator configured to generate a random system configuration file of a structurally variable and complex system; a system builder configured to (i) build a system level netlist and (ii) generate system parameters in response to said random system configuration file; and a simulation verification environment configured to verify said structurally variable and complex system in response to said system level netlist, wherein said simulation verification environment is configured to provide automatic random verification of said structurally variable and complex system in response to said random system configuration file.

18. “Scope of Enablement” Rejections at BPAI Ex parte Blattner (BPAI 2009)

19. “Scope of Enablement” Rejections at BPAI Ex parte Biles (BPAI 2009) 1. A data processing apparatus, comprising: a plurality of registers for storing items of architectural state; a plurality of functional units, each functional unit for performing a processing operation with reference to at least one of said items of architectural state; at least one of said functional units having a register cache associated therewith having one or more cache entries, each cache entry for storing a copy of one of said items of architectural state and a register identifier identifying the register containing that item of architectural state; and control logic for determining a subset of said items of architectural state to be copied in said register cache, said subset comprising at least one item of architectural state which, having regard to the processing operation of the functional unit with which said register cache is associated, is likely to be referred to multiple times.

20. “Scope of Enablement” Rejections at BPAI Ex parte Avinash (BPAI 2009) 1. An image processing system comprising: a temporal processing unit adapted to generate a first derived member of a first dataset from two or more acquired members of said first dataset, said temporal processing unit further adapted to generate a first derived member of a second dataset from two or more acquired members of said second dataset, said temporal processing unit further adapted to compare said first derived member of said first dataset and said first derived member of said second dataset and generate a comparison signal therefrom.

21. “Scope of Enablement” Rejections at BPAI Ex parte Duvaut (BPAI 2009) 1. A Digital Subscriber Line (DSL) communications system configured to provide a power spectral density (PSD) mask for spectral shaping of a dual bit map (DBM) mode downstream transmission, the PSD mask represented by an equation: where PSDDBMsOLrepresents the PSD mask, KADSL_OL represents a constant value, C represents a constant value, f represents a frequency of the downstream transmission, f0represents a constant value, fLP3dBrepresents a 3 decibel (dB) low pass frequency and fHP3dBrepresents a 3 dB high pass frequency.

22. “Scope of Enablement” Rejections at BPAI Ex parte Atkin (BPAI 2009) 9. A system for converting a unidirectional domain name to a bidirectional domain name comprising: a label definer adapted to establish a plurality of labels within a unidirectional domain name by using a pre-determined full stop punctuation mark as a delimiter between said labels, said labels having an original label display order as encountered from left to right; an inferencer adapted to, within each said label, resolve the direction of indeterminate characters by assigning a strong direction left or right to each indeterminate character; and a character reorderer adapted to reorder said characters within each said label of said unidirectional domain name into character display order using the fully resolved characters previously inferenced, thereby converting said uni-directional domain name to a bidirectional domain name in which said original label display order is preserved, and bidirectionality of characters within each label is produced.

23. “Scope of Enablement” Rejections at BPAI Ex parte Ripper (BPAI 2009)

24. “Scope of Enablement” Rejections at BPAI Ex parte Novaes (BPAI 2010)

25. “Scope of Enablement” Rejections at BPAI Ex parte Chaterlea (BPAI 2010)

26. Take-Aways The LWD doctrine mainly applies to biotech and chemical, but can occasionally apply outside that realm. See, e.g., Lizardtech. Ask inventors for more detailed disclosures of invention, including structure and/or algorithms. During prosecution you might be forced to change functional language to “means for” language. Make sure the specification will support this change. Consider including a set of means for claims as insurance against a “scope of enablement” rejection. In litigation, try getting § 112 ¶ 6 to apply to a broad recitation by arguing the same policy concerns raised in Miyazaki, i.e., purely functional language undermines the purpose of § 112 ¶ 6.

27. Citations and Further Reading Citations Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d. 1336, 1349 (Fed. Cir. 2010)(en banc) In re DiLeone, 436 F.2d 1404 (CCPA 1971) Regents of the University of California v. Eli Lilly & Company, 119 F. 3d 1559 (Fed. Cir. 1997) LizardTech v. Earth Res. Mapping, 424 F.3d 1336, 1343-47 (Fed. Cir. 2005) LizardTech v. Earth Res. Mapping, 433 F.3d 1373, 1380 (Fed. Circ. 2006) (rehearing en banc denied) Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946) Ex parte Miyazaki, 89 USPQ2d1207 (BPAI 2008) (precedential) Ex parte Rodriguez, 92 USPQ2D 1395 (BPAI 2009) (precedential) Ex parte Blattner, Appeal No. 2008-004648 (BPAI 2009) Ex parte Biles, Appeal No. 2008-004383 (BPAI 2009) Ex parte Avinash, Appeal No. 2009-1542 (BPAI 2009) Ex parte Duvaut, Appeal No. 2009-0867 (BPAI 2009) Ex parte Atkin, Appeal No. 2008-4352 (BPAI 2009) Ex parte Ripper, Appeal No. 2009-1856 (BPAI 2009) Ex parte Novaes, Appeal No. 2008-004794(BPAI 2010) Ex parte Chaterlea, Appeal No. 2009-001115 (BPAI 2010) David Kappos, Written Description--Little Used Perhaps, But Extremely Useful to Ensure Claims are Appropriately Scoped, David Kappos’ Public Blog (May 5, 2010) (available at http://www.uspto.gov/blog/director/entry/written_description_little_used_perhaps) Further Reading Christopher Holman, Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly and its Progeny in the Courts and PTO,17 Alb. L.J. Sci. & Tech. 1, 26-78 (2007) (available at http://law.bepress.com/expresso/eps/1723/) Donald Chisum, Written Description of the Invention: Ariad (2010) and the Overlooked Invention Priority Principle, 2010 Patently‐O Patent L.J. 72 (available at http://www.patentlyo.com/Chisum.Priority.pdf) Karen G. Hazzah, Ex parte Rodriguez (precedential): 112 is the new 101, All Things Pros (December 14, 2009) (available at http://allthingspros.blogspot.com/2009/12/ex-parte-rodriguez-precedential-112-is.html)