Update on Nanotech-related Initiatives and Examination at the USPTO

1. Update on Nanotech-related Initiatives and Examination at the USPTO Dave T. Nguyen, USPTO Supervisory Patent Examiner, Art Unit 1633 Biotechnology, Pharmaceuticals, Organic Chemistry Tel: 571-272-0731 Email: Dave.Nguyen@uspto.gov June 2006

2. Outline • Overview • Classification • Industry/Academia-USPTO interaction • Continuing Education for Nano-Examiners • Resources for Prior Art Search and Examination • Patenting Nanotechnology June 2006

3. Technology Centers • 7 Technology Centers (TCs) • Biotechnology, Organic Chemistry (TC 1600) • Chemical and Materials Engineering (TC 1700) & Designs Patents (TC 2900) • Computer Architecture & Software (TC2100) • Communications (TC 2600) • Semiconductors, Electrical & Optical Systems & Components (TC 2800) • Transportation, Construction, Agriculture, National Security & Electronic Commerce (TC 3600) • Mechanical Engineering, Manufacturing and Products (TC 3700) • About 300 Art Units (13-18 examiners per Art Unit) • average 40 Art Units per Technology Center • About 4200 Patent Examiners • average 600 Examiners per Technology Center June 2006

4. Nanotech Patents and Pre-grant Publications Distribution Across Technologies (Years ’74-’05) TC 1600 TC 1700 TC 2100, 2600, 2800 TC 3600, 3700 Biotechnology Chemical Electrical Mechanical 823 729 958 652 June 2006

5. Nanotechnology Subject Matter in TC 1600 • BioDrug Delivery nanostructure • lipid based nanocapsule • fatty acid ester based nanocapsules • polymeric nanosphere/nanocapsule • polymer based micelles • functionalized nano based structure composed of protein, peptide an/or nucleic acids • Dendrimer • self-assembled peptide-amphiphiles • virus like particles • quantum dot based nanoparticles coated with DNA or proteins used in therapy • Medical devices coated with polymeric nanoparticles • Biosensors • biochips • nanotubes and nanowires as sensors • arrays • nanoscale dimensions of embodiments on the sensors • Imaging • nanoparticles as labels • light emitting (i.e. fluorescent) compound attached to or within nanoparticle • no light emitting compound; detection via light-scattering (i.e. SPR) • quantum dot based nanoparticles coated with DNA or proteins used in diagnostic assays. • semiconductor nanocrystals as detectable labels June 2006

6. Diversity in Nanotechnology Patent and Pre-grant Publications Assigned to TC 1600 June 2006

7. Classification Progress (1) • Step-by-step approach to reclassification-a working committee composed of experienced classifying staffs, SPE(s) and Nano examiners was formed in late 2001. • 11/2001-8/2004 - Actively working in developing a new nanotech cross-reference digest by: • Placement of nano-related documents from key word searches • Cross-reference placements of newly issued US patents and US Pre-Grant Applications by examiners from the working committee • 10/2004 - Established a new Nanotechnology cross reference Digest I, Class 977. • 11/2005 – Cross Reference Class 977, Subclasses 700-963 replaces Digest I. June 2006

8. Classification Progress (2) • Class 977 Digest I (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 • As of January 2006, up to about 3170 documents placed, including over 2650 patents and 515 Pre-Grant Publications. • Public Availability Expanded Nanotechnology Class 977 subclass schedule and definitions at: http://www.uspto.gov/web/offices/opc/documents/1850.pdf June 2006

9. Classification Progress (3) • The public may now do a combination of a text query and a cross-reference class 977 search by following these steps at http://www.uspto.gov/patft/index.html: • Step 1- choose either the Issued Patents or the Published Applications database • Step 2 - select the Advanced Search option • Step 3 – enter your query and select years desired. Example, to search “device” and “class 977, subclass 931” enter the query as: -- device and ccl/977/931 -- • Step 4 – Hit the Search button • Step 5 – review search results June 2006

10. XR OR Classification Progress (4) June 2006

11. Classification Progress (5) • The creation of cross reference Class 977 “Nanotechnology” and its expanded 263 subclasses provides the USPTO with: • a consolidated area of search to supplement the patent application examination process. • an enhanced search tool, whereby customers of the USPTO could select and combine a text search along with the cross-reference to class 977. • a mechanism by which Nanotechnology-related US Patent activity can be analyzed by the USPTO and the public June 2006

12. USPTO Nanotechnology Customer Partnership (NCP) • Inaugural event at USPTO on Sept. 11, 2003 • Annual meetings April 20, 2004, May 4, 2005 and 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 June 2006

13. 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 June 2006

14. Continuing Education For Nanotech-Examiners • Monthly Atlantic Nano Forum Training http://www.atlanticnanoforum.org • Nano Training Bootcamp: 7/12/05-7/15/05 at George Washington University • In-House Training/Seminar on Nanotech Related subject matter • Resource Center provided by Scientific and Technical Information Center (STIC) June 2006

15. Continuing Education Scientific and Technical Information Center (STIC) June 2006

16. Search Tools for Nanotechnology Nanotech-related services offered by STIC June 2006

17. Search Tools for Nanotechnology STN WEST Dialog STIC Science Direct EAST June 2006

18. Examination Resource:Creation of a Tag-Team of Nanotech-Examiners in TC 1600 • Experienced Nano-Examiners identified and invited to join the Tag-Team for TC 1600 in January 2006 • Tag-Team finalized and created in March 2006 • Goals of the Tag-Team: • Enhancing proper assignments of nanotechnology applications • Sharing resources on prior art • Helping one another in examination on Nanotechnology • Serving as a Points-of-Contact (POC) List for continuing education on Nanotechnology June 2006

19. Examination Resource:Creation of a Tag-Team of Nanotech-Examiners in TC 1600 June 2006

20. Size Matters in Nanotechnology • Case Law & MPEP Related to Changes in Size/Proportion • 35 USC 102 – Inherency • 35 USC 103 – Obvious to make smaller • 35 USC 112, 1st Paragraph, Enablement June 2006

21. Case Law & MPEP Related to Changes in Size/Proportion • In re Troiel, 124 USPQ 502, 505 (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 Gardner v. TEC Systems, Inc., 220 USPQ 777, 786 • (Fed. Cir. 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, 231 USPQ 833, 840 (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. • MPEP 2144.05 • Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions. June 2006

22. 35 USC 102 – Inherency In re Best, 195 USPQ 430, 433 (CCPA 1977; MPEP 2111.04) • 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. Ex Parte Levy, 17 USPQ2d 1461, 1464 (BPAI, 1990; MPEP 2111.04) • 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. Schering Corp. v. Geneva Pharm., 68 USPQ 1760, 1763 (Fed. Cir. 2003; MPEP 2111.04) • 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. June 2006

23. 35 USC 103 – Obviousness • Aren’t inventors always motivated to make things smaller, faster, 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) June 2006

24. 35 USC 112, 1st Paragraph:Enablement • When is a nanotechnology claim not enabled? Analysis of the Wands Factors and undue experimentation are required. • Example: Claiming a process of making crystalline assembled nanostructures without reciting specific substrates, materials and steps employed, e.g., nano-scale lithography. June 2006

25. 35 USC 112, 1st Paragraph:Enablement Wands Factor Analysis: • The breadth of the claim in relation to the disclosure. • Working examples showing only nano-based lithography • The nature of the invention and level of unpredictability at the time the invention was made: Severe fluctuations both in positions and sizes do occur in self-assembled nanostructures, thereby causing a difficulty in predicting their energetic location and structures required for an envisioned property. See Herbert Kroemer, Phys. Sat. Sol. (a) 202, No. 6, 957-964, page 960, 2005. Conclusion: • The disclosure may not provide sufficient information to enable a person skilled in the art to make and use the full scope of the claimed invention without undue experimentation. June 2006

26. Contact Information Dave T. Nguyen SPE, Art Unit 1633 Tel: 571-272-0731 Email: Dave.Nguyen@uspto.gov June 2006