ENABLEMENT / WRITTEN DESCRIPTION PATENT PROSECUTION PRACTICE

1. ENABLEMENT / WRITTEN DESCRIPTION PATENT PROSECUTION PRACTICE Presented at: Webb & Co.Rehovot, Israel Date:February 21, 2013 Presented by: Roy D. GrossAssociate St. Onge Steward Johnston & Reens LLCStamford, Connecticut, U.S.rgross@ssjr.com

2. 35 U.S.C. § 112, First Paragraph • 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 which it pertains, or with which it is most nearly connected, to make and use the same… • Note: the written description requirement and the enablement requirement are separate requirements. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)

3. Written Description Requirement • is an inquiry/analysis of whether the applicant was in possession of the invention he/she seeks to patent. • “[T]he description must ‘clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.’” Ariad Pharm v. Eli Lilly, 2010 WL 1007369, *13-14 (Fed. Cir. 2010, citing Vas Cath, 935 F.2d at 1563) (emphasis added). MPEP §2163 • ensures that the inventor had possession, as of the filing date of the application, of the specific subject matter claimed. • “The test for sufficiency is whether the disclosure of the application relied upon reasonably coveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad, at, *14 (emphasis added). “[I]t is the specification itself that must demonstrate possession.” Id., at *14.

4. Written Description Requirement (continued) Key Points to Remember • Written Description Requirement is a Question of Fact. • Requires possession of the claimed subject matteras of the filing date. • Specification itself must demonstrate possession. • Determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Why is there a Written Description Requirement? • Ensures that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification. • Ensures that the public receives a meaningful disclosure in exchange for being excluded from practicing an invention for a period of time.

5. Possession of Subject Matter for Claims Drawn to a Single Embodiment or Species • Possession is shown by describing the invention, with all its claimed limitations. Possession may be shown by: • Description of an actual reduction to practice. • Showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete. • Describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. • Note: Applicant does not have to describe exactly the subject matter claimed in the specification.

6. Typical Disclosure to Satisfy Written Description Requirement The Written Description Requirement is typically satisfied by the disclosure of such descriptive means as: • Formulas • Words • Structures • Figures • Diagrams • Functional characteristics when coupled with a known or disclosed correlation between function and structure that fully set forth the claimed invention

7. Possession of Subject Matter for Genus Claims General Rule: • Disclosure of a single species may be sufficient written description to support for a later claimed genus (generic claim) including that species. Bilstad v. Wakalopulos, 386 F.3d 1116, 1124 (Fed. Cir. 2004). Exception: • In applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In reSoll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). If the art is unpredictable, then disclosure of more species is necessary to adequately show possession of the entire genus.

8. Unpredictable Arts • Unpredictable Arts include arts which involve the chemical industry, the experimental sciences, and other such arts where the results are not easily predictable. In reFisher, 427 F.2d 833, 839, (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). MPEP § 2164.03. • The pharmaceutical industry is the prototypical example of a highly unpredictable field.Pfizer v. Teva Pharm., 482 F.Supp.2d 390, 413 (D.N.J. 2007); 2 Chisum on Patents § 5.04.

9. Genus Claims in the Unpredictable Arts • Need adequate description of species – general detail of genus may not be adequate. • “Merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not a species.” Ariad, at *13. • Must show sufficient species to support genus. • “The specification must demonstrate that the applicant has made a generic invention that achieves the claimed result, and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” Ariad, at *12.

10. Ariad Pharm v. Eli Lilly, 598 F.3d 1336, 1341 (Fed. Cir. 2010) (en banc) Exemplary Asserted Claim (rewritten to include claims from which it depends) • 80. [A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-κB-mediated intracellular signaling, the method comprising altering NF-κB activity in the cells such that NF-κB-mediated effects of external influences are modified, wherein NF-κB activity in the cell is reduced] wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB. • Inventors were the first to identify NF-κB and to uncover the mechanism by which NF-κB activates gene expression underlying the body’s immune responses to infection. • The Federal Circuit found that the claims are genus claims, encompassing the use of all substances that achieve the desired result of reducing the binding of NF-κB to NF-κB recognition sites

11. Ariad (continued) Holding • The Federal Circuit held that Ariad’s broad claims were invalid for lack of written description. Although the claims covered all methods of inhibiting NF-κB regulation, the specification only used broad functional language to disclose only hypothetical methods. In other words, Ariad’s patent described a problem—not a solution. Teaching • The decision in Ariad v. Lilly encourages practitioners to carefully consider the support for broad genus claims when drafting the specification. Depending on the technology involved and the breadth of the claims sought, more detail may be necessary to show sufficient possession to satisfy the written description requirement.

12. Prosecution Tips for Satisfying the Written Description Requirement Suggestions • Provide as many figures and examples in specification as possible. Show that the inventor ‘invented’ the claimed subject matter. • Add tables of data for various ranges in the specification so that data points in the upper, middle and lower limits of the ranges are shown. • When claiming a genus, show a “representative number of species” in the specification. Provide adequate details of species that are representative of the entire genus. When there is substantial variation within the genus, describe a sufficient variety of species to reflect the variation. • Claim both genus and species. Claim species in dependent claims. • Do not claim results in claims, claim the structure. If art is unpredictable, add additional detail and examples.

13. Enablement Requirement • is an inquiry/analysis of whether the specification teaches how to make and use the claimed invention. • To be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Alza Corp. v. Andrx Pharma, LLC, 2010 WL 1644060 (Fed. Cir. April 26, 2010)(Emphasis Added). Key Points to Remember • Enablement is a Question of Law. • Determined as of the effective filing date of the application; • Must be enabling to persons of skill in the art. • Full Scope of Claim must be enabled.

14. Scope of the Claims ≤ Scope of the Enablement • “The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” Nat’l Recovery Techs. V. Magnetic, 166 F.3d 1190, 1195-1196 (Fed. Cir. 1999). • A patent need not teach, and preferably omits, what is well known in the art. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991); • “The specification must teach those of skill in the art how to make and how to use the invention as broadly as it is claimed.” In re Goodman, 11 F.3d 1046, 1049 (Fed. Cir. 1993) (Emphasis Added)

15. Wands Factors -> determining whether experimentation is “undue” • The claimed invention must be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988) • Wands Factors: • (A) The breadth of the claims; • (B) The nature of the invention; • (C) The state of the prior art; • (D) The level of one of ordinary skill; • (E) The level of predictability in the art; • (F) The amount of direction provided by the inventor; • (G) The existence of working examples; and • (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. • Claim construction is important in determining whether experimentation is undue!

16. Predictability in the Art • The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). • Even in unpredictable arts, a disclosure of every operable species is not required. • A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944).

17. Full Scope of Claims must be Enabled • Plant Genetic Sys. v. Dekalb Genetics Corp., 315 F.3d 1335 (Fed. Cir. 2003) • Claims at issue were directed to a “plant cell” integrating DNA into its genome. The specification of the patent in Plant Genetic only taught integrating DNA stably into dicot plants. The alleged infringing product made and sold by defendants, however, was a monocot plant. It was disputed whether the claims directed to a “plant cell” were enabled for monocots, and what kind plant cells were covered by the claims. • The Plant Genetic Court found that the claims were directed to both monocot and dicot plants. The Court held that these claims were invalid for lack of enablement because practicing stable gene transformation for monocot cells in 1987 required undue experimentation, as the specification did not show or teach one of skill in the art how to do this.

18. Full Scope of Claims must be Enabled • In re Vaeck, 947 F.2d 448 (Fed. Cir. 1991) (claims directed to cyanobacteria where only one species of cyanobacteria was employed in the working examples of specification. The Court took into account the relatively incomplete understanding of biology of cyanobacteria, and upheld the PTO’s enablement rejection to the broad claims). • Libel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371 (Fed. Cir. 2007) (claims directed to a method of loading a tubular replacement syringe with and without a pressure jacket. The Court held that the claims were invalid because the specification only taught the embodiment without the pressure jacket).

19. Full Scope of Claims must be Enabled • AK Steel v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) (claims directed to a ferrous base ferritic strip made from both Type 1 and Type 2 aluminum. The Court held that that since the specification only taught Type 2 aluminum, the claims were not enabled); • Monsanto Co. v. Syngenta Seeds, 503 F.3d 1352 (Fed. Cir. 2007) (claims directed to a chimeric plant gene. The Court held that the patent claims extended to the cells of all flowering plants and the patent was filed before transformation of monocot cells was possible. Therefore, those skilled in the art could not determine whether the plant gene could carry out the claimed functions and the full scope of the claims were not enabled);

20. Enablement Tips • Suggestions • Cleary define claim terms, so as to support the interpretation in the specification that you desire. Applicants can be their own lexicographer. • Provide as many figures and examples in specification as possible. Add tables of data for various ranges in the specification so that data points in the upper, middle and lower limits of the ranges are shown. • When claiming a genus, show a “representative number of species” in the specification. Provide adequate details of species that are representative of the entire genus. When there is substantial variation within the genus, describe a sufficient variety of species to reflect the variation. • Claim both genus and species. Claim species in dependent claims. • Do not claim results in claims, claim the structure.

21. Enablement Example - U.S. Patent 6,598,603 (EEFD Dec. 31, 1997) Exemplary Claim 1 • A method of treating a patient suffering from a respiratory disease, the method comprising administering to the patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day. • Key term: budesonide composition • Specification discloses examples of a budesonide suspension. The specification does not disclose a budesonide solution. • Question: Is the full scope Claim 1 enabled?

22. Prior Art Enablement • An anticipating reference must be enabled. • An anticipating reference must enable the claimed invention. Impax Labs, Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008). Under 35 U.S.C. § 102, “[a]n ‘anticipating’ reference must describe all of the elements and limitations of the claim in a single reference, and enable one of skill in the field of the invention to make and use the claimed invention.” Merck & Co., Inc. v. Teva Pharms. USA, Inc., 347 F.3d 1367, 1372 (Fed. Cir. 2003) (citations omitted). • For prior art to enable the claimed invention, the description of the prior art must be such that “a person of ordinary skill in the field of the invention can practice the subject matter based on the reference, without undue experimentation.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008).

23. Prior Art Enablement • Prior Art Enablement is similar to enablement under § 112, but no utility requirement. • A reference need not demonstrate utility or efficacy to be enabling in the context of § 102. In re Gleave, 560 F.3d 1331, 1335–36 (Fed. Cir. 2009). No “actual creation or reduction to practice” is required for enablement of a prior art reference. In re Gleave, 560 F.3d at 1134. • Further, “[i]t is not, however, necessary that an invention disclosed in a publication shall have actually been made in order to satisfy the enablement requirement.” In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). • Patents are presumed to be enabled because they are presumed valid. Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354-1355 (Fed. Cir. 2003) (holding that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled.”)

24. Prior Art Enablement Example (U.S. Patent No. 6,598,603) Exemplary Claim 1 • A method of treating a patient suffering from a respiratory disease, the method comprising administering to the patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day. • Key term: budesonide composition • Specification discloses examples of a budesonide suspension. Specification states that: • The therapeutic suspensions can also contain one or more excipients. Excipients are well known in the art and include buffers (e.g., citrate buffer, phosphate buffer, acetate buffer and bicarbonate buffer), amino acids, urea, alcohols, ascorbic acid, phospholipids, proteins (e.g., serum albumin), EDTA, sodium chloride, liposomes, mannitol, sorbitol, and glycerol. Solutions or suspensions can be encapsulated in liposomes or biodegradable microspheres.

25. Real Life Enablement Example (U.S. Patent No. 6,598,603) • Prior art (U.S. Patent No. 5,192,528) discloses a suspension of budesonide composition that discloses budesonide suspended in a liposome. • Prior art discloses method of making a liposome suspension of beclomethasone and lists budesonide as an exemplary corticosteroids taught by the patent. • Patentee argues that prior art is not fully enabled because budesonide suspension not explicitly taught. • Question: Is the prior art ‘528 reference enabled?

26. The End