Nanotechnology-Related Issues at the United States Patent and Trademark Office

1. Nanotechnology-Related Issues at the United States Patent and Trademark Office Bruce Kisliuk, USPTO Group Director, Technology Center 1600 Biotechnology, Pharmaceuticals, Organic Chemistry 571-272-0700 Bruce.Kisliuk@uspto.gov

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

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

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.

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.

6. Current Class 977 Patents As of January 1, 2006

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

8. Distribution Across Technologies(patents and pre-grant publications) (Years ’74’-05) TC 1600 TC 1700 TC 2100, 2600, 2800 TC 3600, 3700 Biotechnology Chemical Electrical Mechanical 823 729 958 652

9. Distribution Across Cl. 977 “Out Dents”

10. Patents As a Statistical Measure Factors 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).

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.

12. Statistics for Nanotechnology-Related U.S. Patents Data 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

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

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

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.

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.

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

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

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)

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.

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

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).

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)

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

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)

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

27. Thank You Bruce Kisliuk, USPTO Group Director, Technology Center 1600 Biotechnology, Pharmaceuticals, Organic Chemistry 571-272-0700 Bruce.Kisliuk@uspto.gov