Avoiding Dysfunctional Functional Claims April 2, th Annual Intellectual Property Law Conference

Distinguished Panelists Greg Cox Assistant General Patent Counsel Eli Lilly and Company Alysa Youngson Hunton & Williams LLP Drew Hirshfeld Deputy Commissioner for Patent Examination Policy United States Patent and Trademark Office 2 Chris Bullard Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P. Moderator:

Spotlight on Functional Claiming 3 On June 4, 2013, the White House issued five Executive Actions to help bring about greater transparency to the patent system and level the playing field for innovators Action Item Number 2: Tightening Functional Claiming. The AIA made important improvements to the examination process and overall patent quality, but stakeholders remain concerned about patents with overly broad claims particularly in the context of software. The PTO will provide new targeted training to its examiners on scrutiny of functional claims and will, over the next six months develop strategies to improve claim clarity, such as by use of glossaries in patent specifications to assist examiners in the software field.

Initial Focus on § 112(f) 4 The Office provides targeted training to assist examiners with: 1.Identifying Means-Plus-Function Limitations 2.Making the Record Clear for Means-Plus- Function Claims 3.Broadest Reasonable Interpretation and Definiteness

Where to Find the USPTO Training Materials 5

Related Links of Interest 6 FACT SHEET: White House Task Force on High-Tech Patent Issues: task-force-high-tech-patent-issues FACT SHEET - Executive Actions: Answering the Presidents Call to Strengthen Our Patent System and Foster Innovation: actions-answering-president-s-call-strengthen-our-p USPTO Training Materials: PTAB Decisions Involving Functional Claiming:

What Role Do Practitioners Play? 7 The new AIA PTAB proceedings shift the emphasis from drafting applications and claims with an infringement first mentality to drafting applications and claims to preserve validity challenges Making the record clear can help to preserve the validity of a challenged patent – See Tempo Lighting, Inc. v. Tivoli, LLC, 109 USPQ2d 1599 (Fed. Cir. 2014); see also In re Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997)

Examples for Discussion 8 Digital Camera Assembly Network Node in a Communication System Antibodies Internet Commerce System (time permitting) Chemical Composition (time permitting) Injection Device (time permitting)

Digital Camera Assembly 9 A patent specification discloses a digital camera assembly for producing a digital image. The assembly includes a digital camera that records digital image data and software that enables editing of the digital image data. Using the software to manipulate the image data recorded by the camera, a digital image can be produced. The digital camera can be a hand-held still camera, a video-camcorder, or a component in a smart phone. The software can be loaded onto the camera, the video- camcorder, or the smart phone. Alternatively, the software can be stored on a computer readable media or downloaded to a tablet or general purpose computer.

Digital Camera Assembly 10 Example Claim Limitations: A.a digital camera for producing a digital image Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the BRI limited to a certain type of digital camera? B.a digital camera assembly for producing a digital image Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the BRI limited to a digital camera, or can it be read on a component of a camera or a camera combined with software?

Digital Camera Assembly 11 Example Claim Limitations (cont.): C.a digital camera means for producing a digital image Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the presumption that § 112(f) is invoked due to the use of means rebutted and why or why not? D.a means for producing a digital image Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the presumption that § 112(f) is invoked due to the use of means rebutted and why/why not?

Digital Camera Assembly 12 Example Claim Limitations (cont.): E.a system for producing a digital image Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the presumption that § 112(f) is not invoked due to the absence of means rebutted and why/why not?

Network Node in a Communication System 13 The specification describes a communication system comprised of several network routing nodes that are connected via a communications network. Each network routing node includes a computer processor and memory that stores routing tables and software (e.g., computer executable instructions). When the network routing node receives data from the communications network, the processor accesses the memory and retrieves routing data that is stored in the routing tables. The processor uses the retrieved routing data to route the communications data over the communications network to another network routing node.

Network Node in a Communication System 14 Example Claim Limitations: A.a system for routing communication data Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is not invoked due to the absence of means rebutted and why/why not? B.a network node for routing communication data Q1: What is the BRI of this claim limitation? Q2: Is the BRI limited to a network node or can it be read on a component of a network node or a network node combined with software?

Network Node in a Communication System 15 Example Claim Limitations (cont.): C.a processor for routing communication data Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is not invoked due to the absence of means rebutted and why/why not? D.a processor configured to route communication data Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is not invoked due to the absence of means rebutted and why/why not?

Network Node in a Communication System 16 Example Claim Limitations (cont.): E.processing means for routing communication data Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is invoked due to the use of means rebutted and why/why not? F.a processing unit for routing communication data Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is invoked due to the use of means rebutted and why/why not?

Network Node in a Communication System 17 Example Claim Limitations (cont.): G.means for routing communication data Q1: What is the BRI of this claim limitation? Q2: Is the BRI limited to the system, the network node and/or the processor?

Antibodies 18 The specification teaches XYZ is involved in human immunological system and describes various disorders relating thereto such as rheumatoid arthritis (RA). The specification states that antibodies capable of binding to XYZ are part of the invention, and asserts that these antibodies can be used therapeutically in conditions in which XYZ is over-produced. Polyclonal antibodies against XYZ were produced and shown to bind XYZ in a binding assay.

Antibodies 19 Example Claim Limitations: A.a)A XYZ antibody for binding XYZ What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the BRI limited to a certain type of XYZ antibody - research antibodies, therapeutic antibodies, mouse antibodies, humanized antibodies, human antibodies, optimized antibodies? Q3: Is the BRI limited to a certain binding affinity, is the binding selective to XYZ?

Antibodies 20 Example Claim Limitations (cont.): B.A XYZ inhibitor for treating RA Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the BRI limited to a XYZ antibody, or can it be read on any inhibitor including XYZ binding proteins (soluble receptors) or small molecule inhibitors?

Antibodies 21 Example Claim Limitations (cont.): C.A XYZ antibody for treating RA Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the BRI limited to a XYZ therapeutic antibody? Q3: Is the BRI limited to a certain binding affinity, is the binding selective to XYZ?

Thank You 22 Questions?

An Internet Commerce System 23 The specification describes an internet commerce system for performing retail transactions. The internet commerce system, which is accessible via a communication network, includes a website that is operated from a data center. The data center includes computer processors and memory that store software (e.g., computer executable instructions) and data for an e- commerce merchant. When a customer makes a purchase via the website, processors at the data center receive the quantity and product information from the customer, access the memory to confirm availability of the product, and process the order on behalf of the customer. Processing the order can include sending instructions to warehouse personnel to package and send the desired product in the specified quantity to an address supplied by the customer.

An Internet Commerce System 24 Example Claim Limitations: A.a system for performing retail transactions Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is not invoked due to the absence of means rebutted and why/why not? B.a data center for performing retail transactions Q1: What is the BRI of this claim limitation? Q2: Is the BRI limited to a data center or can it be read on a component of a data center or a data center combined with software?

An Internet Commerce System 25 Example Claim Limitations (cont.): C.a processor for performing retail transactions Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is not invoked due to the absence of means rebutted and why/why not? D.a processor configured to perform retail transactions Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is invoked due to the use of means rebutted and why/why not?

An Internet Commerce System 26 Example Claim Limitations (cont.): E.a processing unit for performing retail transactions Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is invoked due to the use of unit rebutted and why/why not? F.means for performing retail transactions Q1: What is the BRI of this claim limitation? Q2: Is the BRI limited to the system, the network node and/or the processor?

An Internet Commerce System 27 Example Claim Limitations (cont.): G.means for routing communication data Q1: What is the BRI of this claim limitation? Q2: Is the BRI limited to the system, the network node and/or the processor?

Chemical Composition 28 A patent specification discloses that chemical X is highly effective in treating cardiovascular disease, such as angina, hypertension and congestive heart failure. However, chemical X is relatively unstable and decomposes quickly under normal storage conditions, which reduces the efficacy of pharmaceutical compositions comprising chemical X. The specification describes several ways to stabilize chemical X. One way is to add a stabilizing agent such as an antioxidant to the composition, which chemically prevents the decomposition of chemical X. The antioxidant can be citric acid, ascorbic acid (vitamin C), or tocopherol (vitamin E). Another way is to manufacture the pharmaceutical composition in a manner that isolates chemical X from atmospheric light and humidity, e.g., by forming an opaque coating comprising an antioxidant on the surface of a tablet comprising chemical X, or by sealing chemical X inside an air-tight opaque gelatin capsule. The resultant pharmaceutical compositions are surprisingly stable, have satisfactory shelf life, and exhibit relatively constant efficacy over a satisfactory period of time under normal storage conditions.

Chemical Composition 29 Example Claim Limitations: A.a means for stabilizing chemical X Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the presumption that § 112(f) is invoked due to the use of means rebutted and why/why not? B.an agent for stabilizing chemical X Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the BRI limited to a certain type of stabilizing agent?

Chemical Composition 30 Example Claim Limitations (cont.): C.a stabilizing agent Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the BRI limited to the addition of a stabilizing agent to the composition, or can it be read to include physical stabilization via an opaque coating or an air-tight capsule? D.antioxidant means for stabilizing chemical X Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the presumption that § 112(f) is invoked due to the use of means rebutted and why or why not?

Chemical Composition 31 Example Claim Limitations (cont.): E.an antioxidant in an amount sufficient to stabilize chemical X Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the presumption that § 112(f) is not invoked due to the absence of means rebutted and why/why not?

Injection Device 32 The specification discloses various injection devices that deliver predetermined doses of agents, such as drugs or vaccines, to one of three desired depths: (a) shallow, intradermal depth; (b) an intermediate, subcutaneous depth; (c) or a deeper, intramuscular depth. The disclosed embodiments include both needle and needle-free syringes: – Embodiment X - A combination of an adjustable hilt mechanism and a conventional syringe with a hypodermic needle. – Embodiment Y - A needle-free jet injector that uses a high-pressure narrow jet of the agent instead of a hypodermic needle to penetrate the skin. The jet injector is powered by a compressed gas, supplied from a remote supply via a hose or a built-in cartridge. – Embodiment Z - A needle-free jet injector that uses a high-pressure narrow jet of the agent instead of a hypodermic needle to penetrate the skin. The jet injector is powered by a spring in the device.

Injection Device 33 Example Claim Limitations: A.means for delivering the agent to a patient at a desired depth Q1: What is the broadest reasonable interpretation (BRI) of this claim limitation? Q2: Is the BRI limited to a certain type of injection device? B.injector means for delivering an agent to a patient at a selected one of at least two depths Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is invoked due to the use of means rebutted and why/why not?

Injection Device 34 Example Claim Limitations (cont.): C.needle-free means for delivering the dose of the agent to a patient at selected one of at least two depths Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is invoked due to the use of means rebutted and why/why not? D.an injector for delivering the agent to a patient at selected one of at least two depths Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is not invoked due to the absence of means rebutted and why/why not?

Injection Device 35 Example Claim Limitations (cont.): E.an injection portion that is configurable to deliver an agent from the agent supply portion to a patient at a selected depth Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is not invoked due to the absence of means rebutted and why/why not?

Injection Device 36 Example Claim Limitations (cont.): F.an injector including at least two operational states, each operational state allowing the agent to be delivered to the patient at a different depth relative to the other operational states Q1: What is the BRI of this claim limitation? Q2: Is the presumption that § 112(f) is not invoked due to the absence of means rebutted and why/why not?