AIA and Patent Due Diligence Understanding the AIA Impact and Best - PowerPoint PPT Presentation

Formal Documents in an AIA World • Was the appropriate ADS submitted at the time of filing? • Was it signed? • Did it include correct priority information? • Was an Applicant named? Or was the application filed in the name of the inventors? 24

ADS • Option to name inventors (by “legal” name) and provide inventor mailing address • Option to name “Applicant” – Assignee, person to whom inventors are obligated to assign, other person with sufficient proprietary interest – Can correct Applicant via new ADS • To request change of applicant, file new ADS • Consider carefully whether to name “Applicant” 25

Filing By Other Than Inventor (“Assignee Filing”) AIA SEC. 4 (“shall apply to any patent application that is filed on or after [Sept. 16, 2012]) NEW OLD § 118. Filing by other than inventor. § 118. Filing by other than inventor. A person to whom the inventor has assigned or is under an Whenever an inventor refuses to execute an application for obligation to assign the invention may make an application patent, or cannot be found or reached after diligent effort, a for patent. A person who otherwise shows sufficient person to whom the inventor has assigned or agreed in proprietary writing to assign the invention or who otherwise shows interest in the matter may make an application for patent on sufficient proprietary interest in the matter justifying such behalf of and as agent for the inventor on proof of the action, may make application for patent on behalf of and as pertinent facts and a showing that such action is appropriate agent for the inventor on proof of the pertinent facts and a to preserve the rights of the parties. If the Director grants a showing that such action is necessary to preserve the rights patent on an of the parties or to prevent irreparable damage; and the application filed under this section by a person other than Director may grant a patent to such inventor upon such the inventor, the patent shall be granted to the real party in notice to him as the Director deems sufficient, and on interest and upon such notice to the inventor as the Director compliance with such regulations as he prescribes. considers to be sufficient. Still need to name inventor and provide § 115 inventor documentation. 26

What Does This Mean Right Now? • Any application for patent filed after the effective date (Sept. 16, 2012) is subject to the new provisions of §115 and §118. • “effective filing date” is not relevant to these transition provisions, just the actual filing date. 27

AIA Amendments to 35 USC 120 • Continuing applications filed after March 16, 2013 based on applications filed before March 16 will be under the “old” version of 35 USC § 120 28

Filing in the Name of the Applicant? • USPTO is interpreting the "filed by" language in 35 USC 120 as simply requiring at least one common inventor • PTO suggestion: – (1) file the continuation application naming only the inventors – (2) subsequently, file a new ADS naming the assignee as the Applicant, with a 3.73 certification and Power of Attorney from the assignee • However, the USPTO will recognize priority claims in continuing applications regardless of who is named as the Applicant as long as the requirements of 37 CFR 1.78 are satisfied: – In order for an application to claim the benefit of a prior-filed copending nonprovisional application or international application designating the United States of America, each prior-filed application must name as an inventor at least one inventor named in the later- filed application and disclose the named inventor's invention claimed in at least one claim of the later-filed application in the manner provided by the first paragraph of 35 U.S.C. 112. 29

Naming the Applicant? • It is the nationality or residence of the applicants of a PCT application that determine which Receiving Offices are competent for filing the PCT • As of September 16, if an assignment is in place, and the company is named as the applicant for all countries (and inventors are “inventor only”), then the RO must be selected based on the nationality/residence of the company only – inventor nationality/residents are irrelevant 30

Filing in the Name of the Applicant? • Was the “Applicant” perfected? – If ADS names Applicant, then Applicant must perfect rights to act before payment of issue fee • Assignee must provide “documentary evidence” • Record the assignment 31

The “Applicant” (cont’d) • If application is being prosecuted by “Applicant,” then Applicant should execute the power of attorney • No requirement to satisfy § 3.71 or § 3.73 for Applicant who is initially named in ADS • PTO will accept the signature of a practitioner of record on a §3.73(c) statement on behalf of the assignee without requiring further evidence of the practitioner’s authority to act on behalf of the assignee 32

New Formalities: Statement for Transition Applications • If a nonprovisional application filed after March 16 claims priority to a foreign, U.S. or PCT application filed before March 16 and contains or contained at any time a claim to a claimed invention that has an effective filing date on or after March 16, 2013, the applicant must provide a statement to that effect within the later of – four months from the actual filing date – four months from the date of entry into the national stage – sixteen months from the filing date of the prior-filed application – the date that a first claim to a claimed invention that has an effective filing date on or after March 16, 2013, is presented in the application 33

Examination Guidelines • “If a disagreement between the applicant and an examiner cannot be resolved informally and results in a rejection that would otherwise be inapplicable, the applicant may respond to the merits of the rejection with an explanation of why the Office‘s treatment of the application as a pre-AIA application or an AIA application is improper.” • Appeal: If cannot be resolved, applicant would have to appeal – See pp. 11041 of Exam Guidelines (2/14/13) 34

New Formalities: Certified Copy of Foreign Priority Document • Certified copy of any foreign priority application must be filed within the later of: – 4 months from the actual filing date; or – 16 months from the filing date of the prior foreign application • Certified copy is needed prior to publication of application since U.S. patents and U.S. patent application publications have a prior art effect under the as of their earliest effective filing date, which might be the foreign priority date. • Delayed submission of certified copy of foreign priority document must include petition showing good and sufficient cause for delay and petition fee 35

Ways to Satisfy Certified Copy Requirement • Applicant files certified copy of foreign priority document with USPTO; or • USPTO obtains certified copy of foreign priority document from foreign intellectual property office participating in priority document exchange agreement program (participating foreign office) upon request from applicant; or • Applicant files interim copy of foreign priority document and subsequently files certified copy 36

Note of Caution: Preliminary Amendments • For applications filed on or after September 21, 2004: – Preliminary amendment that is present on the filing date of the application is part of the original disclosure of the application • For applications filed before September 21, 2004: – Preliminary amendment that is present on the filing date of the application is part of the original disclosure of the application if the preliminary amendment was referred to in the first executed oath or declaration under 37 CFR 1.63 filed in the application. • See MPEP § 602 and § 608.04(b) 37

USPTO Guidelines re: Preliminary Amendments • PTO makes distinction between claims added in a preliminary amendment filed on the same day as an application and claims presented at a later date – [A]n amendment ( other than a preliminary amendment filed on the same day as such application ) seeking to add a claim to a claimed invention that is directed to new matter in an application filed on or after March 16, 2013, that, as originally filed, discloses and claims only subject matter also disclosed in a previously filed pre-AIA application to which the application filed on or after March 16, 2013, is entitled to priority or benefit under 35 U.S.C. 119, 120, 121, or 365, would not change the application from a pre-AIA application into an AIA application . 38

Thank You! Lauren Stevens, Ph.D. Global Patent Group, LLC Tel: (650) 387-3813 lstevens@globalpatentgroup.com GLOBAL PATENT GROUP, LLC. 39

AIA and Due Diligence May 29, 2013 for Strafford Donna Meuth Lauren Stevens, Ph.D. Tom Irving GLOBAL PATENT GROUP, LLC.

Disclaimer • These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law. These materials should not be taken as individualized legal advice and do not reflect the views of FINNEGAN, EISAI, or GLOBAL PATENT GROUP LLC. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, FINNEGAN, EISAI, GLOBAL PATENT GROUP LLC or the panelists cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with FINNEGAN, EISAI, GLOBAL PATENT GROUP LLC or the panelists. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. 41

Three Basic Categories of IP Due Diligence 1. Ownership/Transferability – Clear title to that IP – Transferability or assignability of in-licensed technology 2. Freedom to operate (“FTO”)  Freedom to use the target company’s technology without infringing the IP rights of third parties 3. Validity/enforceability – Determination of the validity and enforceability of the target’s IP 42

Overview of Types of FTO Searches • Litigation search (of target and its IP) • FTO search relating to products/services to be acquired/licensed and future products/services • Validity of the key IP assets to be acquired/licensed • Maintenance fees • Ownership: obtain assignments at the PTO, considering possible inventors and their obligations (present and past) 43

Searches: General Considerations • Consider both in-house search resources and outside searchers • Technology specific searchers or preferred searchers having multi- technical capability? • Contact preferred outside searchers (especially patent searchers) in advance to make sure that deadlines can be met – Consider having 2-3 searchers available: reduce possibility of scheduling conflicts or workload causing delay – Which is more important: budget or time? – Establish initial search budget parameters – Confirm a time frame and have searcher commit to it – Rolling basis for results • Reduces delay in analysis of search results 44

Litigation Search • Obvious reasons to check this: – IS THE CLIENT BUYING A LAWSUIT? – How does it affect the deal? – What are the chances of success? • Other reasons – May have duty of disclosure in pending related applications (MPEP 2001.06(c)) • Do you mention to target, if there is a related litigation, and substantive material allegations have not been brought to attention of USPTO? – Broader issue: this concept can apply to any issues discovered that might affect the value of the portfolio – If the problem is correctable, do you wait until the deal goes through? – What if deal is almost certain to go through? 45

Litigation Search (cont.) • Litigation – existence and status – Potential (U.S. and abroad) • Pre-data room searches might not detect – Actual (U.S. and abroad) • Including ITC – Previous litigations • If settled, ask for settlement agreement (need to know rights and obligations imposed by agreement and its limits) – Administrative proceedings • US PTO (ex parte reexams, IPRs, reissues, interferences/derivation proceedings, business method PGRs) – Oppositions 46

Overview of Freedom to Operate Analysis: Will Third Party Patents Impact Business Objectives? • FTO Search: Identify potentially relevant third party patents/applications – Emphasis on competitors’ patents and patents relating to key technology • Determine scope of third party patents – Claim interpretation – claim language/specification/file history • Comparison of construed claims to: – products/services to be acquired/licensed – future products/services • How to manage risk associated with FTO Issues? – Validity analysis – Design-around – License/common ownership-joint research agreement options, pre-AIA, or as broadened under AIA for patents/applications with at least one claim with an effective filing date after March 15, 2013 47

Freedom to Operate Search • Gather information from Target Company on its products, processes, and services sufficient to initiate FTO search – Confidentiality agreements should be in place with Target • Consider pros and cons of buyer’s personnel (e.g., engineers) having access to confidential information. (If the deal does not close, could there be a future allegation of breaching the confidentiality agreement?) • Initiate the FTO search as soon as possible – Search will take some time – Work on other aspect of FTO while waiting for search results • evaluate third party patents and applications cited in file histories of key Target patents and applications • Consider providing useful information to help focus the searcher – What does client want to do with the technology? • Make sure the searcher understands key technology – What are the immediate and long term objectives of client? – What is the competitive landscape? • Provide the FTO searcher with a listing of known competitors 48

Objective: Identify FTO “Show Stopper” US Patents Before Investing Too Much • What is and what is not an FTO “show stopper” – Considerations when third party patent appears to be infringed: • Who is patentee (major competitor v. non-player in market)? – Patentee’s enforcement history (i.e. license, litigate, etc.) • Does target company know of “show stopper”? • Is it truly infringed (claim construction, prosecution disclaimers)? • Design-around possibilities? • Potential damages/injunction relief • Is patent valid and enforceable? • Has license already been obtained? • Can patent be bought? • What if the “show stoppers” are applications? – Check foreign file histories (may be more advanced) • Does target company have patent leverage? 49

FTO Analysis • Analyze results from the FTO search to determine if there are any issues with 3rd party U.S. patents or pending applications – For each patent identified during the FTO search, compare claims to target company’s technology (current and future) – Consider specifications of the third party patents and, if needed, file histories – Categorize as relevant or not • Assess validity of third- party patent claims reading on target company’s technology • Identify technical questions for subsequent discussions with key technical personnel of target • Query target company – Did it know of patent? – Does it have an opinion of counsel on the infringement and validity of the patent? • May not want to see it, but good to know if exists – Does it have a license to practice the patented invention covering the relevant field of use? 50

FTO: Pending Applications • Source of pending patent applications – Directly from search: published patent applications – Close calls on issued patents and check for related continuing cases – Monitoring competitors’ pending patent applications • What to do: – Pending claims are broad and could cover current or future products • Are they patentable? • Should a patentability analysis be undertaken? – Claims could be in state of flux • No enforceable right yet • Closely monitor – yes • Should you submit art to the PTO or to applicant? – PTO: Very risky; not recommended, though expanded prior art submission provisions under AIA – Applicant: risky also, puts burden on applicant to submit – Should a license be sought? Common ownership pursued? 51

Data Gathered (Still Pre-Data Room) • In light of what has been learned so far, develop plan for data room – Provide target with an updated list of information being sought from “data room” and interviews with Target personnel – Request inventory of information in data room • Plan how much time and person power will be needed 52

Interviews at Target Company • People to be interviewed: – Inventors on key patents – Attorneys who prosecuted target’s key patents – Maybe opinion counsel – Attorneys who furnished Orange Book listing opinions, if any – Declarant(s) (if a declaration submitted during prosecution of patents at issue) – Technical people from target with knowledge of technical aspects of products and services and subject matter patented in key patents or relevant third party patents – Target personnel with knowledge of existing or potential IP disputes • An objective: what patents (third parties’ or Novaline’s) were the subject of existing or potential disputes 53

Freedom to Operate • Likely to know at least some of the problematic third party patent(s) from pre-data room investigation and initial FTO searching • Identify existing or threatened claims of infringement based on 3rd party IP – Request target to identify any existing or threatened claims of infringement based on a third party’s IP, including what action, if any, the target has taken regarding those claims. • Licenses? • Opinions? • If threats, basis for DJ? 54

FTO: Threat of a Patent Infringement Action • Legal options – Seek possible redress in reps and warranties, e.g., indemnification • Assess liability exposure • Business method patent • Patent troll (only monetary damages, not injunction) – eBay case: injunctions not automatic; court applies equitable considerations – Offensive options • Declaratory judgment litigation – “case or controversy” ( MedImmune, Inc. v. Genentech, Inc., 127 S.Ct. 764, 166 L.Ed.2d 604 (2007)) • Reexamination – Options before Sept. 16, 2012: ex parte, inter partes – Options after Sept. 16, 2012: ex parte reexamination, inter partes review, post-grant review (PGR for business method claims as of September 16, 2012; PGR for all other claims with effective filing date on or after March 16, 2013) – Risks and limits of reexamination 55

How To Deal With Gaps In Information • After reviewing information in the data room and comparing it to information disclosed in interviews with the Target’s representatives and publicly available information, determine where there are gaps in the data room information – Do any of the gaps relate to critical issues? • Ask the target to provide missing information – If the target is unwilling, is that a red flag? – Could the requested information be highly confidential or privileged? – If the target updates the data room to add documents that the buyer did not request, what could this indicate? • Consider conducting additional discussions with Target’s representatives or other relevant personnel • Can representations and warranties address topics relating to missing/incomplete information? – Also consider requiring the target to schedule specific items and referring to the schedules in the reps and warranties 56

Freedom to Operate • Often FTO is the deal maker or deal breaker – Significant factor to be taken into account in assessing value and structure of deal • Providing an FTO analysis in a timely and thorough manner permits the client to make an informed decision about whether and how to proceed with the transaction – Could be determining factor in evaluating whether current and future business objectives can be met 57

Freedom to Operate - Reporting • The report to the client should address both the risks associated with third party IP and means of managing the risks, including: – Status and potential outcomes (upside/downside) of any current IP litigation involving the target – Likelihood of future IP litigation • Address any infringement allegations made by or to third parties • Provide an overview of the competitive landscape and how the deal might alter the landscape – Scope of identified third-party patents presenting actual or potential blocking issues for current or future products • Client might have a particular interest in patents involving particular technologies and/or patents assigned to particular competitors – Potential risks associated with any identified third party patent applications 58

Freedom to Operate – Reporting (cont.) • The report to the client should address both the risks associated with third party IP and means of managing the risks, including: – Ways of mitigating risks associated with third party patents/applications • Design-around possibilities • Invalidity positions • Attacks – Declaratory Judgment Action – Reexamination- ex parte or inter partes – Smoke Bomb Through Transom: providing the patent applicant with prior art and a claim chart – Interference – IP rights licensed-in by the target • Provide an overview of licensed-in IP rights and extent to which there might not be a full transfer • Significant limitations on term or scope of licenses 59

FTO-Related Representations and Warranties • Examples of topics to cover in FTO-related representations and warranties – Infringement by Target: • No action, suit, proceeding, or investigation is pending or threatened against the Target • Target has not received any communication alleging that the target has violated or would violate any third party IP rights • Target’s business and its products and services do not directly or indirectly infringe any third party IP or violate any contract or license with any third party • Target has not infringed any third party IP in the course of developing any product or service, etc. • Note: Target’s counsel might consider limits, such as knowledge and best efforts to prosecute AIA applications in light of uncertainty of new law. 60

Overview of Analysis of Target Company’s Patents and Applications • Objectives: 1) Will the Target’s patents and applications adequately protect key products and services? 2) Will they be valid and enforceable? Does pre-AIA or AIA law apply? • Process – Identify Target’s IP and focus on the key patents and applications; – Assess scope of key patents/applications (and relevant claims); and – Identify relevant prior art (either from search, file histories, or any other sources). 61

Detailed Evaluation of Target’s Patents and Applications • Coverage/protection: – Do products fall within literal scope of claims of key patents? – Do the claims provide adequate scope of protection to prevent design- arounds? – Are these claims likely to be found valid and enforceable? – Technical information • Review technical information available for current products and services of the target (short term) and for future products and services (long term) • Where are the gaps in the technical information? • Has the target merely provided publicly available information? • Is more needed? • Identify further information to request and key Target personnel that might be able to discuss technical details (see above) 62

Evaluation of Target’s Patents: Scope • Claim construction is fundamental building block for scope of protection and validity analysis; must be done first • Focus on key patents and relevant claims within those patents • Flag potential claim construction issues, such as: – Narrow construction of claim term • Current noninfringement position • Future vulnerability to design-around claims – Broad construction • Problems with prior art – Ambiguity (defective claim drafting) • Indefiniteness issues (35 U.S.C. § 112(b)) • Consider foreign counterparts for consistency in claim interpretation positions 63

Evaluation of Target’s Patents: Scope • Framework for claim construction = Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) – “The specification is always highly relevant to claim construction and is the single best guide to the meaning of a claim term in dispute.” – “The specification necessarily informs the correct construction of the claim.” • special definition given to a claim term by the patentee • intentional disclaimer, or disavowal, of claim scope by the inventor – “It is appropriate to rely heavily on the written description for guidance as to the meaning of the claims.” – “Importantly, the person of ordinary skill is deemed to have read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” 64

Arguments in Related Cases May Affect Scope • Consider related U.S. patents and applications and any available foreign patents and applications, including their file histories – Microsoft Corp. v. Multi-Tech Systems, Inc., 357 F.3d 1340 (Fed. Cir. 2004): Statement in prosecution of one patent to construe a claim term in three patents sharing a common specification – Hakim v. Cannon Avent Gp., plc, 479 F.3d 1313 (Fed. Cir. 2007): Narrowing arguments in a parent case that were not expressly rescinded in prosecution of continuation application, operated to narrow the claim. “Although a disclaimer made during prosecution can be rescinded, permitting recapture of the disclaimed scope, the prosecution history must be sufficiently clear to inform the examiner that the previous disclaimer, and the prior art . . . may need to be re- visited.” See also, Heuft Systemtechnik GmbH v. Industrial Dynamics Co, Ltd. 2008 WL 2518562 (Fed. Cir. June 25, 2008)(unpublished). 65

Arguments Made In Corresponding Foreign Patent Applications May Affect Scope • In evaluating infringement under the doctrine of equivalents, “representation[s] to foreign patent offices should be considered ... when [they] comprise relevant evidence.” [citing Caterpillar]. • Representations made to foreign patent offices are relevant. – Tanabe v. US ITC, 109 F.3d 726 (Fed. Cir. 1997) 66

More on Arguments In Corresponding Foreign Patent Applications • Caterpillar Tractor Co. v. Berco, S.p.A., 714 F.2d 1110, 1116, 219 U.S.P.Q. 185, 188 (Fed. Cir. 1983) – Alleged infringer raised Caterpillar’s instructions to foreign counsel indicating that Berco's equivalent embodiment was not contemplated – “Though no authority is cited for the proposition that instructions to foreign counsel and a representation to foreign patent offices should be considered, and the varying legal and procedural requirements for obtaining patent protection in foreign countries might render consideration of certain types of representations inappropriate, there is ample such authority in decisions of other courts and when such matters comprise relevant evidence they must be considered. Stratoflex, Inc. v. Aeroquip Corp., (Fed. Cir. 1983).” [found insufficient in this case – infringement judgment affirmed]. • See also, discussion of Therasense in validity/enforceability slides, infra . 67

Review Specification and Prosecution History for Special Definition and/or Language of “Clear Disavowal” • Language that one of ordinary skill in the art would understand to change or narrow the ordinary meaning of the claim terms – Computer Docking Station Corp. v. Dell, Inc., 519 F.3d 1366 (Fed. Cir. 2008). – Bayer v. Elan, 212 F.3d 1241 (Fed. Cir. 2000). – Alloc Inc. v. ITC, 342 F.3d 1361 (Fed. Cir. 2004). – SciMed Life Systems, Inc. v. ACS, Inc . (Fed. Cir. 2001). 68

Evaluation of Target’s Patents: Technical Information • Compare the construed claims to available technical information relating to the target’s current products/services, future targets/services, and likely design-arounds – Reevaluate gaps in available technical information – Identify further information to request from target – Based on the evaluation, prioritize claims for validity studies 69

Thank You! Presenters ’ Contact Information Donna Meuth Associate General Counsel Eisai Inc. Donna_Meuth@eisai.com Tel: 978-837-4862 70

AIA and Due Diligence May 29, 2013 for Strafford Donna Meuth Lauren Stevens, Ph.D. Tom Irving GLOBAL PATENT GROUP, LLC.

Disclaimer • These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law. These materials should not be taken as individualized legal advice and do not reflect the views of FINNEGAN, EISAI, or GLOBAL PATENT GROUP LLC. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, FINNEGAN, EISAI, GLOBAL PATENT GROUP LLC or the panelists cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with FINNEGAN, EISAI, GLOBAL PATENT GROUP LLC or the panelists. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. 72

Three Basic Categories of IP Due Diligence 1. Ownership/Transferability – Clear title to that IP – Transferability or assignability of in-licensed technology 2. Freedom to operate (“FTO”)  Freedom to use the target company’s technology without infringing the IP rights of third parties 3. Validity/enforceability – Determination of the validity and enforceability of the target’s IP 73

For Now, Practitioners Will Have to Operate in the Dark; Courts Will Ultimately Interpret the AIA • USPTO recognizes also: – “The Office appreciates that the courts may ultimately address questions concerning the meaning of AIA 35 U.S.C. 102 and 103. However, as a practical matter, the Office needs to provide examination guidelines so that the public is aware of how the Office will apply AIA 35 U.S.C. 102 and 103. The Office considers its interpretation of AIA 35 U.S.C. 102 and 103 as set forth in these examination guidelines to be the correct interpretation of AIA 35 U.S.C. 102 and 103 based upon the statutory language of the AIA and its legislative history.” See Examination Guidelines, 78 Fed.Reg. 11,061 (Feb. 14, 2013) 74

“effective filing date” is the key to navigating the road- map of the AIA and considering March 15/16 issues! 75

35 U.S.C. § 100(i)(1): Effective Filing Date for Claimed Invention • § 100(i)(1) The term ‘ effective filing date ’ for a claimed invention in a patent or application for patent means — – (B) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under section 119, 365(a), or 365(b) or to the benefit of an earlier filing date under section 120, 121, or 365(c). – (A) if subparagraph (B) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or • Entitlement does not necessarily require best mode (AIA SEC. 15(b)) 76

For Analyzing Validity/Patentability in a Due Diligence • What law was the patent examined under? • Was that correct? • What law are current patent applications being examined under? • Is it correct? • Worth moving pre-AIA claims to a mixed application (JMM)? 77

“Old” § 102 and § 103: All Claims EFD Before 3/15/13 • Pre-AIA §102(a)-(g) Could apply to certain patents until at least through March 15, 2034! – seven subsections • §102(a): known or used by others; § 102 (b): statutory bar―sale, offer for sale, patented, published by anyone; §102 (c): abandoned; §102 (d): first patented elsewhere; §102(e): prior patents & published applications of others; §102(f): derivation; §102(g): first to invent; – combination of both the “novelty” requirement and a set of “loss of right” to patent provisions; no clear delineation between the two, or so it is argued by some. • Pre-AIA §103 – three subsections • (a) non-obviousness requirement from 1952 Patent Act; • (b) amendments in light of Biotechnology Process Patent Act of 1995; and • (c) provisions relating to commonly assigned patents and patents developed pursuant to Joint Research Agreements. 78

Prior Art Under the AIA New 35 U.S.C. §102: All Claims EFD After 3/15/13 and JMM’s (At Least One Claim with EFD Before 3/16/13 and At Least One Claim with EFD After 3/15/13) (a)(1): A public disclosure ANYWHERE in the world before the EFD of the claimed invention; OR (a)(2): Patent filing disclosures (in the U.S. or PCT designating the U.S.) that later become public, that name another inventor, and were effectively filed before the EFD of the claimed invention. b) Exceptions from prior art c) Expands exceptions subject to CREATE Act (joint research agreements/mergers); and d) new definition of “effectively filed” for 102(a)(2) (sort of like old 102(e)) 79

Prior Art Under the AIA New 35 U.S.C. §102 • What is prior art under the new law, absent a Nomiya ‐type admission, must either form – a § 102(a)(1) public disclosure – something made “available to the public” in the new words found in AIA §102(a)(1); or – an “effectively filed” AIA § 102(a)(2) patent filing disclosure. Effectively filed AIA § 102(a)(2) art requires that ultimately at least one of the following three documents publish (“special publications”): • a U.S. patent; • a U.S. patent application, or • a U.S.‐designating PCT application. Note: “Office does not view the AIA as changing the status quo with respect to the use of admissions as prior art.” Examination Guidelines pp. 11064 and 11075. 80

First AIA Transition Provision: EFD after 3/15/13 • SEC. 3(n)(1) Except as otherwise provided in this section, the amendments made by this section shall take effect upon the expiration of the 18-month period beginning on the date of the enactment of this Act, [March 16, 2013] and shall apply to any application for patent …that contains or contained at any time : A. a claim to a claimed invention that has an effective filing date as defined in section 100(i) [remember: “entitled to”] …, that is on or after the effective date described in this paragraph [March 16, 2013] ; or B. a specific reference under §§ 120, 121, 365(c) to any patent or application that contains or contained at any time such claim. [antecedent for “such claim” has to be sub.para. (A)?] 81

Second Transition Provision: EFD Before 3/16/13 and After 3/15/13!! • SEC. 3(n)(2): The provisions of sections 102(g), 135, and 291 of title 35, United States Code, as in effect on [March 15, 2013], shall apply to each claim of an application for patent, and any patent issued thereon, for which the amendments made by this section also apply, if such application or patent contains or contained at any time — – (A) a claim to an invention having an EFD as defined in section 100(i) of title 35, United States Code, that occurs before [March 16, 2013] ; or – (B) a specific reference under section 120, 121, or 365(c) of title 35, United States Code, to any patent or application that contains or contained at any time such a claim . 82

FITF Examination Guidelines: SEC. 3(n)(2) • “section 3(n)(2) does indicate that the provisions of 35 U.S.C. 102(g), 135, and 291 as in effect on March 15, 2013, shall apply to “each claim” of an application for patent, and not simply the claim or claims having an EFD that occurs before March 16, 2013, if the condition specified in section 3(n)(2) occurs. Therefore, “each claim” of an application presenting a claim to a claimed invention that has an effective filing date before March 16, 2013, but also presenting claims to a claimed invention that has an effective filing date on or after March 16, 2013, is subject to AIA 35 U.S.C. 102 and 103 and is also subject to the provisions of 35 U.S.C. 102(g), 135, and 291 as in effect on March 15, 2013.” See pp. 11069, 11072 of Examination Guidelines (2/14/13) 83

SEC. 3(n)(2): the Mixer! • Some may seek out SEC.3(n)(2), owing to advantages of AIA. – Elimination of Metallizing Engineering forfeiture (according to USPTO); – liberalization of the CREATE ACT and common ownership in 102(c); – possible elimination of pre-AIA statutory bars that are not AIA prior art!!! 84

If You Find a Potential Issue in a Due Diligence, Can You Change or Correct Claim to Priority? A X B March 16, 2013 C add claim only entitled X to C filing date D abandoned at Date Z, D can’t disclaim priority Date Z claim to C and replace it with a priority claim to X to get back to pre-AIA 85

“ E ntitled to priority” vs. “Entitled to claim priority” • AIA §100(i)(1) relating to entitlement to benefit or priority , “entitled … to priority/benefit” • Corresponding language in AIA §102(d) defining when subject matter found in a patent filing is to be regarded as having been effectively filed, “entitled … to claim the priority/benefit ” 86

FITF Examination Guidelines: “Entitled to” and “Entitled to Claim ” • “The AIA draws a distinction between actually being entitled to priority to, or the benefit of, a prior-filed application in the definition of effective filing date of a claimed invention in AIA 35 U.S.C. 100(i)(1)(B), and merely being entitled to claim priority to, or the benefit of, a prior-filed application in the definition of effectively filed in AIA 35 U.S.C. 102(d).” Merely entitled to Entitled to claim v. priority/benefit priority/benefit of of prior-filed app prior-filed app Definition of effective filing date (EFD) Definition of effectively filed See pp. 11078 of Examination Guidelines (2/14/13). 87

M ore “Effectively Filed” for US patents and US/PCT -designating US applications ( § 102(a)(2)): § 102(d) • § 102(d) PATENTS AND PUBLISHED APPLICATIONS EFFECTIVE AS PRIOR ART . – For purposes of determining whether a patent or application for patent is prior art to a claimed invention under subsection (a)(2) , such patent or application shall be considered to have been effectively filed , with respect to any subject matter described in the [US] patent or [US or PCT designating the US] application- • “(2) if the patent or application for patent is entitled to claim a right of priority under section 119, 365(a), or 365(b), or [entitled] to claim the benefit of an earlier filing date under section 120, 121, or 365(c), based upon 1 or more prior filed applications for patent, as of the filing date of the earliest such application that describes the subject matter.” [“entitlement” trumps “describes” - therefore enablement is required?] • “(1) if paragraph (2) does not apply, as of the actual filing date of the patent or the application for patent” 88

“Effectively Filed” v. EFD • Generally, the “EFD” is the actual patent application filing date in the case of a still-pending application, unless the claimed invention is entitled to priority/benefit of an earlier patent filing. • EFD has nothing to do with §102(a)(2) but rather with assessing the validity/patentability of a claimed invention in view of §§ 102(a)(1) and (2). – Effectively filed has everything to do with §102(a)(2) as prior art. 89

“Effectively Filed” v. EFD • This entitlement to priority/benefit exists where (1) a claim for priority/benefit is made, and (2) the earlier patent filing contains written description and enablement support of the claimed invention, as the AIA expressly removed the requirement of disclosing the best mode in an earlier application for the purposes of showing entitlement to priority/benefit. • Best Mode : Note that the best mode requirement still exists at least for all US nonprovisional patent filings because it remains in 35 U.S.C. 112(a). 90

FITF Examination Guidelines: Requirements for §112 Support v. Requirements for Anticipatory or Obviousness Prior Art Under §102(a)(1) and (2)/ § 103 • • … However, in order for a prior art document to “To provide support for a claim describe a claimed invention under AIA 35 under 35 U.S.C. 112(a), it is U.S.C. 102(a)(1) or (a)(2), the prior art necessary that the specification document need only describe and enable one describe and enable the entire skilled in the art to make a single species or scope of the claimed invention . embodiment of the claimed invention …the [... continued ...] disclosure may be cited for all that it would reasonably have made known to a person of ordinary skill…the description requirement of AIA 35 U.S.C. 102(a)(1) and (a)(2) does not preclude an examiner from applying a disclosure in an obviousness rejection under AIA 35 U.S.C. 103 simply because the Emphasis added disclosure is not adequate to anticipate the claimed invention under AIA 35 U.S.C. 102(a)(1) or (a)(2) .” See pp. 11074 of Examination Guidelines (2/14/13)

FITF Examination Guidelines: Requirements for §112 Support v. Requirements for Anticipatory or Obviousness Prior Art Under §102(a)(1) and (2)/ § 103 “AIA 35 U.S.C. 102(d) requires that a prior-filed application to …AIA 35 U.S.C. 102(d) which a priority or benefit claim does not require that is made must describe the subject matter from the U.S. However, this description meet patent, U.S. patent application the requirements of publication, or WIPO published 35 U.S.C. 112(a).” application relied upon in a rejection. Emphasis added See pp. 11078 of Examination Guidelines (2/14/13) 92

Hilmer Doctrine Abolished by §102(d) • For claims with an effective filing date after March 15, 2013 (and all claims in a JMM application), a foreign priority date can be used offensively as prior art under AIA’s 35 U.S.C. §102(a)(2) against the patent claims of others, as long as the subject matter in one of the three special publications was at least described in a foreign priority document which was “effectively filed” relative to the relevant subject matter. ( See 35 U.S.C. §102(a)(2) and §102(d)). 93

Hypothetical on ’001 and ’002 Patents: Pre-AIA • Pre- AIA, the ’001 US application because of Hilmer , was not §102(e)/103 prior art against the claims of the ’002 patent because ’001 priority was irrelevant. 10-17-2000 10-1-2002 11-1-1999 1-18-2000 10-19-2000 6-11-2002 ’001 ’002 ’001 ’002 ’001 ’002 issue US US Issue foreign foreign appln appln priority priority filed filed appln appln filed filed 94 94 94

Hypothetical on ’001 and ’002 Patents: AIA - Possible Game Changer • If the ’001 patent was “effectively filed” (relevant disclosure of ’001 patent at least described in the ’001 foreign application) on 11 -1- 1999, then the ’001 patent is §102(a)(2) prior art as of 11-1-1999 against the claims of the ’002 patent, whether the effective filing date of the relevant claims of the ’002 patent is 1 -18-2000 or 10-17-2000. 10-17-2000 10-1-2002 11-1-1999 1-18-2000 10-19-2000 6-11-2002 ’001 ’002 ’001 ’002 ’001 ’002 issue US US Issue foreign foreign appln appln priority priority filed filed appln appln filed filed 95 95 95

Hypothetical on ’001 and ’002 Patents: AIA - Is it a Game Changer? Is there a § 102(b)(2) exception to remove the ’001 § 102(a)(2) prior art against the ‘002 patent claims? Whatever the effective filing date of the ’002 claim, §102(b)(2) could apply to remove the §102(a)(2) prior art if the requirements of either §102(b)(2)(A) or §102(b)(2)(B) can be met. 10-17-2000 10-1-2002 11-1-1999 1-18-2000 10-19-2000 6-11-2002 ’001 ’002 ’001 ’002 ’001 ’002 issue US US Issue foreign foreign appln appln priority priority filed filed appln appln filed filed 96 96 96

Impact of § 102(d)(2) – Prior Art Date Following publication, disclosure has retroactive availability as prior art as of the date effectively filed for novelty and obviousness purposes. Prior art date Pub. Appl. U.S. Prov. U.S. Appl. English USPAT Appl. Non-Prov. Prior art date Pub. PCT Appl. CN PCT Chinese USPAT Prior art date (des. Pub. U.S.) PCT Appl. FR USPAT PCT French (des. U.S.) • NO geographical or language distinction • Entitlement to claim priority/benefit of US Prov App., CN app., and FR app. • Important date is when “effectively filed” not when published. • Hilmer doctrine abolished. 97

New 35 U.S.C. § 102(b) – Defines Exceptions to Prior Art “grace period” • §102 (b)(1) EXCEPTIONS . (1) DISCLOSURES MADE 1 YEAR OR LESS BEFORE THE EFFECTIVE FILING DATE OF THE CLAIMED INVENTION. — A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if — (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter [independently?] disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 98

Exception ONLY Good For Exact Subject Matter Described: Before or After? § 102(b)(1) Exception ONLY for the same subject matter earlier disclosed; “related” subject matter could still be used against the patentee under § 103 and MIGHT even preclude the claimed invention from being patentable at all because of § 103 !!! What if inventor discloses X and the disclosee discloses X and Y? See pp. 11061 of Examination Guidelines (2/14/13). The same argument regarding disclosed vs. related subject matter is also made regarding §102(b)(2), which is the exception to §102(a)(2). Notably, §102(b)(2) does not include a grace period and includes three classes of exceptions, whereas §102(b)(1) includes only two classes of exceptions. 99

New 35 U.S.C. § 102(b) (con't) • §102 (b)(2) EXCEPTIONS – … (2) DISCLOSURES APPEARING IN APPLICATIONS AND PATENTS. — A disclosure shall not be prior art to a claimed invention under subsection (a)(2) if- (A) the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor; (B) the subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (C) the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention , were owned by the same person or subject to an obligation of assignment to the same person. No “grace period” 100