Intro to Section 112: Enablement Prof. Merges

¶ 1 Written Description of Claimed Invention Disclosure/Enablement, § 112 ¶ 1 Enablement of one skilled in the art without undue experimentation of: how to make how to use ¶ 1 Best Mode contemplated by inventor ¶ 2,6 Claims - definiteness

U.S.C. § 112: ¶ 1 Disclosure/Enablement, § 112 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 the best mode contemplated by the inventor of carrying out his invention.

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.

U.S.C. § 112: ¶ 3 A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form.

U.S.C. § 112: ¶ 4 Subject to the following paragraph, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.

U.S.C. § 112: ¶ 5 A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered.

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.

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

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.” Rotating handle at end of bar Cutting element attached to bar Base, with passageway U-shaped bar Claim Elements Rotating handle at end of bar

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

Claims – page 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.

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.

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

Sawyer and Man Commercial product Is this relevant to question of infringement in this case?

Edison Patent Is this relevant to this case? Is it a defense for McKeesport Light that it has a license from Edison?

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

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

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.

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

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

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

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?

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.

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

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).

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

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

(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.

Figure 11 is a “conceptional view of an electronic sensor assembly 201 built according to the teachings of this invention. This sensor contains a sensing mass 202 which moves relative to housing 203 in response to the acceleration of housing 203 which accompanies a side impact crash.” The specification further states that the motion of the sensing mass “can be sensed by a variety of technologies using, for example, optics, resistance change, capacitance change or magnetic reluctance change.” The enablement of this electronic side impact sensor is at issue in this appeal.

According to Delphi, providing an enabling disclosure of only mechanical side impact sensors is insufficient to satisfy the enablement requirement because the full scope of the claims is not enabled. Delphi further responds that the short recitation of an electronic sensor in the specification does not in fact enable an electronic side impact sensor because it does not teach one skilled in the art how to make and use such a sensor without undue experimentation. – 501 F.3d at 1281

[O]nly one short paragraph and one figure relate to an electronic sensor. Importantly, that paragraph and figure do little more than provide an overview of an electronic sensor without providing any details of how the electronic sensor operates. Figure 11 shows a very general view of an electronic side impact sensor.

[T]he claims includ[e] both mechanical and electronic side impact sensors. Disclosure of only mechanical side impact sensors does not permit one skilled in the art to make and use the invention as broadly as it was claimed, which includes electronic side impact sensors. Electronic side impact sensors are not just another known species of a genus consisting of sensors, but are a distinctly different sensor compared with the well- enabled mechanical side impact sensor that is fully discussed in the specification.

Thus, in order to fulfill the enablement requirement, the specification must enable the full scope of the claims that includes both electronic and mechanical side impact sensors, which the specification fails to do. – 501 F.3d at 1285.

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

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.

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

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, ). It has also been isolated from the common snowdrop Galanthus nivalis (Boit, 1954).

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

‘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

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

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.

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....

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)

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

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, Book Supp. At 51.

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.

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...

[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 supp. At 54.