March 2006 1

Nanotechnology-Related Issues at the United States

Patent and Trademark Office

Bruce Kisliuk, USPTOGroup Director, Technology Center 1600Biotechnology, Pharmaceuticals, Organic Chemistry571-272-0700Bruce.Kisliuk@uspto.gov

March 2006 2

Nanotechnology Issues

Nanotech Patents - How to define Classifying Nanotechnology Patents Nanotech Patenting Statistics USPTO Customer Partnership Initiative Examining and Prior Art Issues Patentability Issues

March 2006 3

Nanotechnology Patents – how to define them

What defines a “Nanotechnology Patent” Look at NNI definition

Based on a text search and manual review, currently a limited number of patents that actually claim a nanotechnology invention

Many more patents that include nanotech-related terms in the disclosure

March 2006 4

Classification Issues Cross-Reference Art Collection

• Appended to a class schedule or grouped as a separate class

• Populate with the small number of existing documents from IPC Class B82B associated with their specific technical fields

• Identify additional U.S. patent documents through key word searches and screening of relevant U.S. classifications to add to the collections

Established a new Nanotechnology cross-reference digest, Class 977, in October 2004.

March 2006 5

Classification Issues

Class 977 Digest (Oct. 2004) has now expanded from a single “digest” to a cross-reference art collection of 263 new subclasses

• Posted and searchable in mid-February 2006 Started this project 2 years ago

• Team of about 25 examiners reviewed and assigned these documents into the new subclasses

• Currently up to about 3170 documents placed, including over 2650 patents and 515 Pre-Grant Publications.

March 2006 6

Current Class 977 Patents

Technology CenterNumber

of Patents

1600 - Biotechnology and Organic Chemistry 8161700 - Chemical and Materials Engineering 6602100 - Computer Architecture Software and Info. Security 2

2600 - Communications 1552800 - Semiconductor, Electrical, Optical Systems 6223600 - Transportation, Construction, Electronic Commerce 31

3700 - Mechanical Eng., Manufacturing and Products 362

Total 2648As of January 1, 2006

March 2006 7

Current Class 977 Patents(based on the year the patent issued)

Year TC1600 TC1700 TC2100 TC2600 TC2800 TC3600 TC3700 total1974 0 0 0 0 0 0 2 21975 0 0 0 0 0 0 1 11976 0 0 0 0 0 0 0 01977 0 0 0 0 0 0 0 01978 1 0 0 0 0 0 0 11979 0 0 0 0 0 0 0 01980 1 2 0 0 0 0 1 41981 1 1 0 0 0 0 1 31982 0 3 0 0 0 0 0 31983 0 1 0 0 0 0 1 21984 0 1 0 0 0 0 3 41985 1 1 0 0 0 0 0 21986 0 2 0 0 1 0 1 41987 2 0 0 0 0 0 5 71988 0 7 0 0 0 0 0 71989 4 8 0 0 4 0 1 171990 1 12 0 0 1 0 0 141991 6 3 0 3 6 0 4 221992 8 5 0 4 18 0 7 421993 3 3 0 7 24 0 3 401994 14 5 0 7 28 0 6 601995 13 5 0 10 21 0 7 561996 34 12 0 10 14 0 13 831997 43 12 0 5 20 2 12 941998 56 21 0 14 26 2 21 1401999 84 172 0 8 28 0 23 3152000 76 45 0 6 11 2 30 1702001 113 46 0 22 47 3 40 2712002 137 60 1 16 131 8 48 4012003 201 122 1 21 180 7 69 601

March 2006 8

Distribution Across Technologies(patents and pre-grant publications)

Biotechnology 26%

Electrical30%

Chemical23%

Mechanical21%

(Years ’74’-05) TC 1600 TC 1700 TC 2100, 2600, 2800 TC 3600, 3700 Biotechnology Chemical Electrical Mechanical

823 729 958 652

March 2006 9

Distribution Across Cl. 977 “Out Dents”

902: SPECIFIED USEOF NANOSTRUCTURE

30%

963: MISCELLANEOUS

839: MATHEMATICAL ALGORITHMS, E.G., COMPUTER

SOFTWARE, ETC., SPECIFICALLY ADAPTED FOR MODELING CONFIGURATIONS

OR PROPERTIES OF NANOSTRUCTURE

700: NANOSTRUCTURE

38%

840: MANUFACTURE, TREATMENT,

OR DETECTION OFNANOSTRUCTURE

31%

March 2006 10

Patents As a Statistical MeasureFactors to consider regarding patent statistics: Select between Patent Grants and Patent Applications. Grants

issued reflect the actual IP protection, but applications filed are closer to the time of invention. Often consider the time of application filing of patents that are granted.

Clarify the definition of nanotechnology being used to identify a nanotech-related patent.

Select how to screen for nanotech-related patents. For example, using a key-word search (of the full-text or only certain sections of the patent document), or alternatively search by classification (if one is available).

Select how to define the origin or assignee/company on the invention. For example, residence/country of first named inventor, or country of company of ownership/assignee (if available).

March 2006 11

U.S. Patent Data vs. Global Patenting Publication

Data A search of just U.S. Patent data does not reflect

global patenting activity. U.S. Patent data identifies those seeking patent

protection in the U.S. only. Certain challenges in making comparisons using global

patent data due to differences in patent practices. For example, differences in when patent publications

occur relative to filings, and the time from application filing to grant.

Differences in patentability standards. Accounting for filings of the same invention in multiple

countries.

March 2006 12

Statistics for Nanotechnology-Related U.S.

PatentsData on U.S. Patents is fairly consistent regardless of the way it is searched, about 60% of U.S. Patents related to nanotech are U.S.-origin (awarded to U.S. inventors or U.S. assignees/owners).

Huang et al paper 2004, key-word search on seven basic nanotech terms in USPTO data base, country based on assignee or owner. Whether search of full-text or just title/claims, whether 1976-2002 or just 2003, about 60% U.S. Patents awarded to U.S. inventors or U.S. assignees/owners.

Informal search of patents placed in new USPTO cross-reference Class 977 on nanotechnology (placement project not yet complete), whether first named inventors or assignees/companies, whether 1977-2004 or just 2003, about 60% U.S. Patents awarded to U.S. inventors or U.S. assignees/owners.

Next most active countries: Japan, Germany, and France

March 2006 13

Global Patent Statistics Informal search using Derwent World Patent Index (DWPI). DWPI includes about 40 countries. Identify nanotechnology by either Derwent codes for

nanotechnology or nanotechnology International Patent Classification (IPC) codes (did not use key-word search because it would be limited to English language translations of abstracts for many foreign patent publications)

Identified any type of patent publication (includes pre-grant publications as well as grants).

Evaluated nanotech-related patent publication data in a variety of aspects:

Country of first-named inventor Country of assignee/owner First occurring patent publication Same inventions filed in 3 or more countries

March 2006 14

Patent Global Statistics - First Occurring Patent Publication

Using the country of first-named inventor, 1986-2003, 26.6% nanotech-related to U.S. inventors (highest).

Next countries: China (25.3%), Japan (19.7%), Germany (8.2%) Using the country of assignee or owner, 1986-2003,

31.1% nanotech-related to U.S. assignee/owner (highest). Next countries: China (25.2%), Japan (17.3%), Germany (8.4%)

China has one year (2001) of over 900 publications which appears to be an anomaly since year before was about 15 and year after was about 60.

Data on country of inventor in DWPI is incomplete, missing in about 40% of hits. The percent cited is of those hits with a known country of inventor.

This evaluation only counted the first occurring patent publication for a single invention, since many inventions are filed in multiple countries

March 2006 15

Patent Global Statistics - Invention filed in 3 or More Countries

Using the country of first-named inventor, 1986-2003, 31.0% nanotech-related to U.S. inventors (highest).

Next countries: Japan (26.7%), Germany (11.5%), Korea (6.8%) Using the country of assignee or owner, 1986-2003,

37.4% nanotech-related to U.S. assignee/owner (highest). Next countries: Japan (25.2%), Germany (10.8%), Korea (5.8%)

This evaluation counted inventions with patent publications in three (3) or more countries. This would indicate inventions in which a high level of global protection in multiple countries was being pursued.

March 2006 16

Nanotechnology Patent Statistics: Summary

U.S.- origin inventors and assignees/owners have: the most nanotechnology-related U.S. Patents by a

substantial margin, the most nanotechnology-related patent publications globally,

but by a narrower margin (followed closely by Japan), and the most nanotechnology-related inventions with patent

publications in 3 or more countries, indicating a more aggressive pursuit of international IP protection.

The next most active countries pursuing nanotechnology-related patents globally include Japan, Germany, Korea, and France.

While there is a high number of Chinese patent publications in one year (2001), this appears to be an anomaly, and is not reflected in the data regarding filings in 3 or more countries.

March 2006 17

USPTO Nanotechnology Customer Partnership (NCP)

Inaugural event at USPTO on Sept. 11, 2003 Annual meetings April 20, 2004 and May 4, 2005.

Next NCP scheduled for March 28, 2006. Goals of the Partnership:

• Sharing concerns and information• Establishing technical training programs for examiners• Helping identify sources of prior art• Helping applicants better understand what we do,

hopefully lead to better applications and better patents

March 2006 18

Nanotech Customer Partnership

Contacts and Information:To be added to the USPTO Nanotechnology Customer Partnership

emailing list, to offer a speaker for technical training for USPTO examiners, or to suggest a source for searching nanotechnology-related prior art:

Jill Warden, SPE 1743, 571-272-1267 Jill.Warden@USPTO.GOV

 For other general nanotechnology-related or examination-related issues: Bruce Kisliuk, Group Director TC1600, 571-272-0700

Bruce.Kisliuk@USPTO.GOV 

March 2006 19

Examination & Searching Due to multi-disciplinary nature of nanotech,

currently no specific nanotech Group or Art Unit

Currently identifying examiners in each Technology Center and building expertise

Most activity in: TC1700 (materials), TC2800 (semiconductors), and TC1600 (biotech/pharmaceuticals)

March 2006 20

Examination & Searching Searching is done using normal

examiner resources (patent files and NPL via automated search systems and EIC support).

STIC Nanotech Resource Page, examiner source of books-journals, classification (Derwent codes and IPC), data bases, reference tools, and Web resources.

March 2006 21

Patentability Issues in Examining Nanotech

35 USC 102 – Inherency

35 USC 103 – Obvious to make smaller (?)

35 USC 112, 1st Paragraph, Enablement

Product-by-Process Claims

Case Law Related to Changes in Size

March 2006 22

35 USC 102 – Inherency The claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In relying upon the theory of inherency, the examiner must provide

a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art. Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990).

Simply put, the fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention. Schering Corp. v. Geneva Pharm., 68 USP2d 1760 (CAFC 2003).

March 2006 23

35 USC 103 – Obviousness

Aren’t inventors always motivated to make things smaller, fast, more sensitive? Maybe, but…

Obviousness Requires A Reasonable Expectation Of Success

The prior art can be modified or combined to reject claims as prima facie obvious as long as there is

a reasonable expectation of success. - In re Merck

& Co., Inc., 800 F.2d 1091 (Fed. Cir. 1986)

March 2006 24

35 USC 112, 1st Paragraph: Enablement

Scope of Enablement: Full scope of claims

Enablement for specific claimed use

When is a claim not enabled? Undue Experimentation

Wands Factors

March 2006 25

Product-by-Process Claims The patentability of a product does not depend on its method

of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)

The structure implied by the process steps should be considered when assessing the patentability of product-by- process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)

March 2006 26

Case Law Related to Changes in Size/Proportion

Application of Troiel, 274 F.2d 944 (CCPA 1960) • It is well established that the mere change of the relative size of the co-acting members of a known combination will not endow an otherwise unpatentable combination with patentability.

In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976)• Mere scaling up … would not establish patentability in a claim to an

old process so scaled.

In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)

• where the only difference between the prior art and the claims was a recitation of relative dimensions…would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.

Texas Instruments v. ITC, 805 F.2d 1558 (Fed. Cir. 1986) • a mere change in size due to improved miniaturization by technological advance does not in itself save the accused devices from infringement

March 2006 27

Thank YouBruce Kisliuk, USPTOGroup Director, Technology Center 1600Biotechnology, Pharmaceuticals, Organic Chemistry571-272-0700Bruce.Kisliuk@uspto.gov