June 2006 1

Update on Nanotech-related Update on Nanotech-related Initiatives and Examination Initiatives and Examination

at the USPTOat the USPTO

Dave T. Nguyen, USPTOSupervisory Patent Examiner, Art Unit 1633Biotechnology, Pharmaceuticals, Organic Chemistry

Tel: 571-272-0731Email: 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

Biotechnology

26% Electrical

30%

Chemical

23%Mechanical

21%

(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

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

Nanotechnology Nanotechnology Subject Matter in TC 1600Subject 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

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 AvailabilityExpanded 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

Classification Progress (4)

OR XR

June 2006 11

The creation of cross reference Class 977 “Nanotechnology” and its expanded 263 subclasses provides the USPTO with:

1) a consolidated area of search to supplement the patent application examination process.

2) an enhanced search tool, whereby customers of the USPTO could select and combine a text search along with the cross-reference to class 977.

3) a mechanism by which Nanotechnology-related US Patent activity can be analyzed by the USPTO and the public

Classification Progress (5)

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

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)

Continuing Education For Nanotech-Examiners

June 2006 15

Continuing EducationScientific and Technical Information Center (STIC)

June 2006 16

Search Tools for NanotechnologySearch Tools for NanotechnologyNanotech-related services offered by STIC

June 2006 17

DialogDialog

STNSTN

WESWESTT

EASTEAST

STICSTIC

Search Tools for NanotechnologySearch Tools for Nanotechnology

Science Science DirectDirect

June 2006 18

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

Examination Resource: Creation of a Tag-Team of Nanotech-Examiners in TC 1600

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)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 unpatentablecombination with patentability.

In re Gardner v. TEC Systems, Inc., 220 USPQ 777, 786 In re Gardner v. TEC Systems, Inc., 220 USPQ 777, 786 (Fed. Cir. 1984)(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)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 2144.05MPEP 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.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

Dave T. Nguyen SPE, Art Unit 1633

Tel: 571-272-0731Email: Dave.Nguyen@uspto.gov

Contact Information