ANTICIPATION BY INHERENCY IN PRIOR ART

James O. Wilson Supervisory Patent Examiner Technology Center 1600 USPTO (571) 272-0661 [email protected]

1

REQUIREMENTS OF ANTICIPATION

• In order for a claimed invention to be anticipated under 35 U.S.C. § 102(b), all of the elements of the claim must be found in one reference. See Scripps Clinic & Research Found. v. Genentech Inc., 927 F.2d 1565, 1576, 18 USPQ2d 1001, 1010 (Fed. Cir. 1991). • “A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or

inherently

described, in a single prior art reference.”

Verdegaal Bros.v. Union Oil Co. of California

, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir.1987).

2

EXAMINER’S BURDEN

The examiner has the initial burden of establishing a prima facie case of anticipation by pointing out where all of the claim limitations appear in a single reference. See

In re Spada

, 911 F.2d 705, 709, 15 USPQ2d 1655 (Fed. Cir. 1990).

In re King

, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).

3

35 USC 102 Multiple References May be Used

MPEP 2132.01 Multiple References 35 U.S.C. 102 Rejections

Normally, only one reference should be used in making a rejection under 35 USC 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when extra references are cited to: (A) Prove the primary reference contains an enabling disclosure; (B) Explain the meaning of a term used in the primary reference; or (C) Show that a characteristic not disclosed in the reference is inherent 4

Additional Reference To Prove Anticipatory Reference contains an enabling disclosure.

In re Donohue

,

766 F.2d 531, 226 USPQ 619 (Fed Cir. 1985).

Compound claims were rejected under 35 USC 102(b) over a publication in view of two patents. The publication disclosed the compounds. The patents taught the skilled artisan how to prepare general class of compounds. Applicant’s argued no motivation to combine. Court held that the publication taught all of the elements and no motivation to “combine” was necessary. The patents were cited to show that the ability to make the claimed compounds were in the public’s possession before applicant’s invention. 5

Additional Reference To Explain Meaning of Terminology

In re Baxter Travenol Labs

.,

952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991).

Claims directed to a blood bag system with a bag containing DHEP. Claims rejected over a technical progress report which taught the same blood bag system excluding a DHEP containing bag. The technical report disclosed commercially available bags could be used in blood bag system. Extrinsic evidence (depositions, declarations, Applicant’s admissions) showed commercially available DHEP containing blood bags at time the technical report was written. Since commercial bags included bags containing DHEP, the claims were held anticipated.

6

Additional Reference to prove an undisclosed characteristic is inherent

Atlas Power Co. v. IRECO, Inc.

,

190 F.3d 1342, 1349, 51 USPQ 1943, 1948 (Fed. Cir 1990) .

Extrinsic evidence may be used when a reference is silent about an asserted inherent characteristic. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference and that it would be recognized by a skilled artisan. As long as there is evidence of record establishing inherency, failure to contemporaneously recognize an inherent property, function or ingredient of the prior art does not preclude a finding of anticipation. 7

Old things not patentable upon disclosure of a new property, use, function Merely claiming a new use, a new function or an unknown (new) property which is necessarily present in the prior art does not necessarily make the claim patentable.

See

In re Best,

562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).

In re Schreiber

, 128 F.3d 1473, 44 USPQ2d 1429 (Fed. Cir. 1997).

8

Examiner’s Burden to Establish Anticipation by Inherency

1. To establish inherency the extrinsic evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the alleged anticipatory reference.

2. The examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the alleged inherent characteristic necessarily flows from the teachings of the applied prior art. 9

Anticipation by Inherency of Composition Product and Apparatus Claims

Titanium Metals Corp. v. Banner

. 778 F.2d

775, 227 USPQ 773. Where the claimed products and the prior art products are identical in structure or composition or are produced by identical processes, a prima facie case of anticipation is established. 10

Composition is physically the same, it must have the same properties If prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Products of identical composition cannot have mutually exclusive properties. A chemical compound and its properties are inseparable.

In re Spada

, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) 11

Non-functional printed matter does not distinguish claimed product from otherwise identical prior art product to obviate anticipation

Where the only difference between a prior art product and a claimed product is printed matter (i.e. instructions), which is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.

In re Ngai 70 USPQ2d 1862 (CAFC 2004) and In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983).

12

Product-by-process claims not limited to the manipulations of the recited steps , only the structure implied by the steps

• Determination of the patentability of a product-by-process claim is based on the identity of the product, not its method of production. If the product in the product-by-process claim is the same (or obvious) from a product of the prior art, the claim is unpatentable, even if the product was made by a different process.

In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).

When assessing patentability, the product-by-process claim has potential patentability when the manufacturing steps impart identifiable, distinctive structural characteristic to the final product.

13

Anticipation by Inherency PROCESS CLAIMS Claims Anticipated when a Device carries out Process

A Prior art device may anticipate a claimed process if the device carries out the process during normal operation. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.

In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).

14

Anticipation by Inherency PROCESS CLAIMS Claims drawn to use of old composition directed to known result or property are anticipated

Use of an old composition or structure directed to a result or property disclosed in the art are which logically flows from the “use” as disclosed in the art anticipates claims drawn to said “use”.

In re

May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).

15

Additional Cases of Interest

16

Inherent Characteristics

• In re Cruciferous Sprout Litigation, 301 F.3d 1343, 64 USPQ 2d 1202 (Fed. Cir. 2002).

Brassica recognized that some sprouts are rich in glucosinolates and high in Phase 2 enzyme-inducing activity. But these activities have existed as long as sprouts themselves. The prior art teaches sprouting and harvesting the very same seeds that the patents recognize as producing sprouts rich in glucosinolates and having high Phase 2 enzyme-inducing potential. 17

Inherent Result

Schering Corp. v. Geneva Pharmaceuticals Inc., 67 USPQ2d 1664 (CA FC 2003) Prior patent need only describe how to make DCL in any form encompassed by compound claim covering DCL.

Prior patent for antihistamine loratadine is anticipatory prior art reference to patent covering metabolite of loratadine called descarboethoxyloratadine or “DCL,” since prior patent discloses administering loratadine to patient, and since inherent result of administering loratadine to patient is formation of DCL.

18

Anticipated or Obvious….?

• Smithkline Beecham Corporation and Beecham Group, P.L.C. v. Apotex Corp., Apotex, Inc., and Torpharm, Inc.

70 USPQ2d 1737 (CA FC 2004) .

• Prior art related to paroxetine formulations prepared by a process without water, thereby overcoming a “pink hue” discolouration problem some paroxetine tablets developed. Dry granulation method disclosed in the prior art led to the finding of anticipation.

19

Thank You

James O.Wilson

Supervisory Patent Examiner Technology Center 1600 USPTO (571) 272-0661 [email protected]

20