Intro to Section 112: Enablement

1. Intro to Section 112: Enablement Prof. Merges 9.6.2012

2. Disclosure/Enablement, § 112 U.S.C. § 112: ¶ 1 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, and shall set forth thebest modecontemplated by the inventor of carrying out his invention.

3. Disclosure/Enablement, § 112 ¶ 1Written Descriptionof Claimed Invention ¶ 1Enablementof one skilled in the art without undue experimentation of: • how to make • how to use ¶ 1Best Modecontemplated by inventor ¶ 2,6Claims- definiteness

4. U.S.C. § 112: ¶ 2 The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.

5. U.S.C. § 112: ¶ 6 An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

7. CLAIM 1: ELEMENTS Rotating handle at end of bar U-shaped bar Cutting element attached to bar Base, with passageway

8. Enablement/Written Description Cheese Slicer Specifications, ¶ X “The handle may be turned to ... draw the cutting element taut so that it may properly perform its cutting function.” Claim Elements Rotating handle at end of bar Rotating handle at end of bar Cutting element attached to bar Base, with passageway U-shaped bar

9. The Incandescent Lamp Patent Incandescing conductor Bamboo discovered as an incandescing conductor.

10. Claims – page 262 1. An incandescing conductor for an electric lamp, of carbonized fibrous or textile material and of an arch or horseshoe shape, substantially as hereinbefore set forth.

11. System claims 2. The combination, substantially as hereinbefore set forth, of an electric circuit and an incandescing conductor of carbonized fibrous material, included in and forming part of said circuit, and a transparent hermetically sealed chamber in which the conductor is enclosed.

12. Narrow “picture” claim – p. 263 3. The incandescing conductor for an electric lamp, formed of carbonized paper, substantially as described.

13. Important to keep in mind: who is suing whom, under which patent? • The lawsuit is for infringement of the Sawyer & Man patent • What is the essence of the suit? Does McKeesport’s product infringe Sawyer & Man’s claims?

14. Sawyer and Man Commercial product • Is this relevant to question of infringement in this case? • Not really; the suit is for infringement of the patent, not similarity of commercial products

15. Edison Patent • Is this relevant to this case • Is it a defense for McKeesport Light, in the suit under the Sawyer & Man patent, that it has a license under Edison’s patent?

16. Overlapping and Blocking Patents • Quite possible for defendant to have patents that plaintiff infringes • Irrelevant to plaintiff’s cause of action

17. What is defendant’s defense? “Is the complainant entitled to a monopoly of all fibrous and textile materials for incandescent conductors?”

18. If the patentees had discovered in fibrous and textile substances a quality common to them all, or to them generally, as distinguishing them from other materials, such as minerals, etc., and such quality or characteristic adapted them peculiarly to incandescent conductors, such claim might not be too broad.

19. Instead of confining themselves to carbonized paper, as they might properly have done, and in fact did in their third claim, they made a broad claim for every fibrous or textile material, when in fact an examination of over six thousand vegetable growths showed that none of them possessed the peculiar qualities that fitted them for that purpose. -- page 266

20. Policy rationale Was everybody then precluded by this broad claim from making further investigation? We think not.

21. Edison’s experiments – relevance? • How does this evidence bear on the question of the proper scope of Sawyer and Man’s patent?

22. Page 268 [H]ow would it be possible for a person to know what fibrous or textile material was adapted to the purpose of an incandescent conductor, except by the most careful and painstaking experimentation?

23. If … as before observed, there were some general quality, running through the whole fibrous and textile kingdom, which distinguished it from every other, and gave it a peculiar fitness for the particular purpose, the man who discovered such quality might justly be entitled to a patent; but that is not the case here.

24. Sawyer and Mann Patent Claimed: “All Fibrous and textile material” (6,000 plus embodiments) Enabled: Carbonized paper, plus?

27. Janssen v. Tiva • Pioneering vs, generic drug makers • Intertwined patent law and FDA law/regulations • Generic pharmaceutical co.’s vs. Pioneer pharmaceutical co.’s

28. Janssen v. Tiva 1. A method of treating Alzheimer's disease and related dementias which comprises administering to a patient suffering from such a disease a therapeutically effective amount of galanthamine or a pharmaceutically-acceptable acid addition salt thereof.

29. Mechanism Acetylcholinesterase inhibitors like galantamine increase the amount of acetylcholine available for binding to . . . receptors.

30. Galantamine, the compound Galantamine, a tertiary alkaloid, has been isolated from the bulbs of the Caucasian snowdrops Galanthus woronowi (Proskumina, N. F. and Yakoleva, A. P. 1952, Alkaloids of Galanthus woronowi. II. Isolation of a new alkaloid. (In Russian.) Zh. Obschchei Khim. (J. Gen. Chem.) 22, 1899 1902). It has also been isolated from the common snowdrop Galanthus nivalis (Boit, 1954).

33. Related patents 7,160,559, assigned to Janssen, controlled release formulation of galantamine, issued 2007 Role of intervening prior art

34. ‘318 Patent Specification • Just over 1 page long . . . • 6 Prior art references cited and discussed • 2 Papers showed that galanthamine affected nervous system activity • 4 papers on animal studies and galanthamine

35. Prosecution History Dr. Davis did not learn the results of the animal testing experiments -- which suggested that galantamine could be a promising Alzheimer's disease treatment -- until July 1987, after the '318 patent had issued

36. Drug development timeline After the '318 patent issued in May 1987, Dr. Davis licensed the patent in November 1995 to Janssen. In February 2001 Janssen received approval from the Food and Drug Administration (“FDA”) for using galantamine to treat mild to moderate Alzheimer's disease.

37. District court holding The district court alternatively found that the specification and claims did not “teach one of skill in the art how to use the claimed method” because the application “only surmise[d] how the claimed method could be used” without providing sufficient galantamine dosage information . . . .

38. Utility and Enablement If a patent claim fails to meet the utility requirement because it is not useful or operative, then it also fails to meet the how-to-use aspect of the enablement requirement. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1358 (Fed.Cir.1999)

39. Why is this invention not enabled? • “Tossing out mere ideas” not enough • Mere research proposals not enough • Harm from granting patents “too early”

40. Very similar to utility; same policy Allowing ideas, research proposals, or objects only of research to be patented has the potential to give priority to the wrong party and to “confer power to block off whole areas of scientific development, without compensating benefit to the public.” Brenner, 383 U.S. at 534 (footnote omitted). -- Janssen.

41. Timing is again key . . . The results from the '318 patent's proposed animal tests of galantamine for treating symptoms of Alzheimer's disease were not available at the time of the application, and the district court properly held that they could not be used to establish enablement.

42. Obviousness v. Enablement Janssen tried to establish enablement based on the prior art But Janssen had to distinguish and minimize the prior art in overcoming the obviousness rejection . . .

43. Proposing testing, vs. proof [T]he specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient. – Casebook.

44. Updating Incandescent Lamp • Federal Circuit: • Enablement is an issue of fact • Standard has not changed Patents are required to "teach those skilled in the art how to make and use the full scope of the claimed invention without 'undue experimentation.' " Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed.Cir.1997).

45. Updating, continued . . . • Automotive Technologies Intern., Inc. v. BMW of North America, Inc.,501 F.3d 1274 (Fed Cir 2007)

49. Claim 1. A side impact crash sensor for a vehicle having front and rear wheels, said sensor comprising: (a) a housing;  (b) a mass within said housing movable relative to said housing in response to accelerations of said housing;  (c) means responsive to the motion of said mass upon acceleration of said housing in excess of a predetermined threshold value, for initiating an occupant protection apparatus; and 

50. (d) means for mounting said housing onto at least one of a side door of the vehicle and a side of the vehicle between the centers of the front and rear wheels, in such a position and a direction as to sense an impact into the side of said vehicle.