Leahy-Smith America Invents Act List of Changes

1. An Update on the America Invents Act and Changes in Patent Office Procedures and Examination- An Anecdotal Analysis

2. The “Leahy-Smith America Invents Act” (AIA) significantly amends U.S. Patent Law. The following presentation summarizes the important changes.

3. Leahy-Smith America Invents ActList of Changes • “First to File” • Prior Art Definition • Disclosure “Grace Period” • Pre-Issuance • 15% Fee Increases • Micro-Entities • Prioritized Examination • Third Party Submissions • Post-Issuance • Existing Procedures • Inter Partes Review • Post Grant Review • Derivation Proceedings • Supplemental Examination • Third Party Submissions • Litigation • Prior Use Definitions • Best Mode Requirement • False Marketing

4. “FIRST TO FILE”

5. “First to File” • The AIA changes the current U.S. patent system from a "first to invent” system to a “first to file” system. This is consistent with patent laws throughout most of the world. • A “first to invent” system gives priority to the first to invent. Evidence supporting conception of the claimed invention prior to the filing date of the application may be considered to determine the first inventor of the invention. • A “first to file” system gives priority to the application/invention with the earliest filing date. • Effects: • Applicants will no longer be able to rely upon an earlier date of conception when prior art has an earlier date then the effective filing date if the prior art is not their own discloser. • An inventor who waits to file an application may risk losing his or her patent rights to an inventor who invented later but filed first. Effective Date: March 16, 2013 and applicable to any application with an effective filing date on or after that date.

6. New Definition of Prior Art • The AIA modifies what constitutes anticipatory prior art: § 102. Conditions for patentability; novelty ‘‘(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless— ‘‘(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or ‘‘(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. • Effects: • The date that prior art is effective is determined by the earliest effective filing date (“first to file”).  • The inclusion of the language “otherwise disclosed to the public” allegedly expands the type of prior art that can be used to prevent a patent from issuing or that can be used to invalidate a patent in a civil action. • Prior public use or prior sale anywhere qualifies as prior art (prior public use and sale is no longer limited to the U.S.). Effective Date: March 16, 2013 and applicable to any application with an effective filing date on or after that date.

7. Disclosures : “Grace Period” • The AIA modifies the conditions for “swearing behind” a disclosure: § 102. Conditions for patentability; novelty ‘‘(b) 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 disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly. • Effects: • An applicant can only “swear behind” a disclosure when the disclosure is made one year or less before the effective filing. • The disclosure must be made by the inventors or another who disclosed the subject matter directly or indirectly from the inventors.( Previously, Inventors could “swear behind” a disclosure regardless of the author.) Effective Date: March 16, 2013 and applicable to any application with an effective filing date on or after that date.

8. PRE-ISSUANCE

9. 15% Surcharge • Applies to almost all fees across the board including fees for original filings, examination, continued examination, and maintenance fees. • Already in effect.

10. Micro-Entities • Newly coined “Micro-Entities” will receive a 75% discount on most USPTO fees. • Micro-Entities include: • Institutions of Higher Education, defined as a public or non-profit accredited institution that admits post-secondary students for programs of not less than 2 years; or • A small entity that: • Has not been named as an inventor on more than 4 previously filed US non-provisional patent applications (not including inventions assigned based upon prior employment); • Does not have an income of more than 3x the median US household income; and • Has not conveyed or contractually promised to convey rights or to an entity that has an income of more than 3x the median US household income. Effective Date: Immediately.

11. Prioritized Examination • Prioritized examination can now be obtained for utility and plant patent applications. • The USPTO states the “goal is to provide a final disposition within twelve months, on average, of prioritized status being granted. ” • A maximum of 10,000 requests will be granted per fiscal year, although the USPTO may choose to revise that cap in the future.  • The cost is $4,800. ($2,400 for small entities.) • Prioritized applications may have no more that 4 independent claims and 30 claims total. • The USPTO may “provide for prioritization of examination of applications for products, processes, or technologies that are important to the national economy or national competiveness without recovering aggregate cost of providing such prioritization.” Effective Date: September 26, 2011.

12. Third Party Submissions • Any third party may submit “for consideration and inclusion in the record of a patent application, patents, published applications, or other printed publication of potential relevance to the examination of the application[.]” • The submission must be accompanied by a concise description of the asserted relevance of each document. • The submission must be made before the earlier of notice of allowance or the later of (i) six months after the date on which the application was published, or (ii) the date of first rejection of any claim by the examiner during the examination of the application of patent. Effective Date: September 26, 2012. Applies to any patent application filed before, on or after the effective date.

13. POST-ISSUANCE

14. Existing Procedures • Ex Parte Patent Reexamination • Patent owner or a third party request for the reexamination of an issued patent, at any time during the enforceability of the patent. (Remains largely unchanged by the AIA) • Inter PartesPatent Reexamination • Third party request for the reexamination of an issued patent from a post November 29, 1999 application, at any time during the enforceability of the patent. (Will be phased out starting March 16, 2012 and replaced by Post Grant Review proceedings and Inter Partes Review proceedings) • Patent Interferences • Proceeding used to determine “priority of invention” when two or more parties claim identical or substantially identical inventions. (No longer available due to “first to file” rule, replaced with Derivation proceedings) • Reissue • A reissue application permits a patent owner to correct an error in an issued patent.  A typical “error” correctable by reissue is the failure to claim the full scope of the invention.  Other correctable errors include inaccuracies in the specification, or the failure to claim foreign priority. (AIA deletes requirement that error must have occurred “without any deceptive intention.”)

15. Post Grant Review • The AIA creates “Post Grant Review” proceedings in order to provide patent challengers with an expanded basis to challenge patents. • A Post Grant Review can be filed by anyone but the patent owner within nine months of the patent’s issue date. • The threshold for review is whether it is more likely than not that at least one of the challenged claims is unpatentable or, alternatively, whether the petition raises “a novel or unsettled legal question that is important to other patents or patent applications.” • The challenger can raise invalidity on the grounds the novelty, non-obviousness, sufficiency of the description, or patentability eligibility.  • A Post Grant Review will not be granted if the petitioner has already filed a civil action challenging the validity of the patent. • Estoppel Effect: Estoppel exists for any ground that was raised or “reasonably could havebeen raised” during Post Grant Review. Effective Filing Date: One year after enactment and applicable to all patents having an effective filing date on or after March 16, 2013.

16. Inter Partes Review • “Inter partes review” proceedings have been created to replace the current “inter partes reexamination” proceedings. • Differences from post-grant review : • The request cannot be filed until nine months after a patent issues or after a post-grant review has terminated. • The request must be filed within one year after service of an infringement complaint or before the third party requester filed a court action alleging invalidity. • The petitioner can only seek to cancel one or more claims on the grounds of Obviousness or Novelty only. • The threshold is whether there is a “reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged”. (Formally whether substantial new question of patentability was raised). • Retroactive Effective Date: One year after enactment and applicable to all patens issued before, on or after enactment.

17. Derivation Proceedings • The AIA creates Derivation Proceedings to replace soon-to-be obsolete Interference Proceedings (inter party priority contests) : ‘‘§ 135. Derivation proceedings ‘‘(a) INSTITUTION OF PROCEEDING.—An applicant for patent may file a petition to institute a derivation proceeding in the Office. The petition shall set forth with particularity the basis for finding that an inventor named in an earlier application derived the claimed invention from an inventor named in the petitioner’s application and, without authorization, the earlier application claiming such invention was filed. • A petition to the Patent Trial and Appeal Board must be made within one year of “the first publication of a claim to an invention that is the same or substantially the same as the earlier application’s claim to the invention,” and must be supported by evidence. • If the Board finds derivation it will “correct the naming of the inventor in any application or patent at issue.” Effective Date: Derivation proceedings will begin March 16, 2013 and are applicable to any application with an effective filing date on or after that date.

18. Supplemental Examination • Permits consideration, reconsideration or correction of information believed to be relevant. • A request for Supplemental Examination can only be requested by the patent owner. • The threshold is whether a substantial new question of patentability is found to exist.  If a substantial new question exists the patent will be reexamined. • The prior art to be considered for this proceeding is not limited to patents and printed publications and includes undisclosed material information.  • Patent owners can use this procedure to cure false statements or misrepresentations, for example made in the specification, declarations or responses to Office Actions. • Information reconsidered, considered or corrected cannot be the basis for unenforceability of the patent. Effective date: applies to any patent issued before, on, or after that September 16, 2012

19. Third Party Submissions • Any person at any time may cite to the USPTO in writing: • Prior art consisting of patents or printed publications which that person believes has a bearing on the patentability of any claim of the patent. • The submission will become part of the file if the person citing the prior art explains in writing the pertinence and manner of applying the prior art to at least one 1 claim (Original provision is unaltered by the AIA) • Statements of the patent owner filed in a proceeding before a Federal court or the USPTO in which the patent owner took a position on the scope of any claim of a particular patent. • Only usable to determine proper meaning of a patent claim in reexamination, post grant and inter partes review proceedings. (New provision under the AIA)

20. LITIGATION

21. Prior Use • The AIA expands the prior use defense, making it available to an alleged infringer who was using any patented invention more than one year before the patent application was filed. (The defense was previously only available to alleged infringers of patented methods.) • The prior use defense cannot be used again Higher Learning Institutions or Technology Transfer organizations. Effective Date: Immediately, not retroactive

22. Best Mode • The Best Mode requirement necessitates that a specification set forth the best mode contemplated by the inventor of carrying out his invention. • AIA still requires the inventor disclose the best mode but states that “failure to disclose the best mode shall not be the basis on which any claim of a patent may be canceled or held invalid or otherwise unenforceable.” • It is unclear as of yet what the penalty will be for failure to disclose the best mode. Effective: Immediately, not retroactive

23. False Marketing • The AIA restricts standing to bring false marketing suits granting to the U.S. government or a person who has suffered a competitive injury as a result of the violation. • Marking a patent with an expired patent will no longer be a violation of the statute. • Effective Date: Immediately, retroactive

24. MISCELLANEOUS

25. Miscellaneous • Human Organism Patent • “[N]o patent may issue on a claim directed to or encompassing a human organism. • Appeals from Post Grant Review and Inter Partes Review must be made in federal court • USPTO will establish 3 or more satellite offices.

26. Patent Office Examinations- An Update General Trends: Unity of Invention- Patent Examiners are now with great frequency issuing restriction requirements with Invention Groups and also requiring species election within Invention Groups -almost invariably; -some flexibility in terms of species/sub-genuses. Requires the filing of Divisional Applications -Generally more than One In Order to Get Desired Claim Scope

27. Written Description Issues - Rejection of Application Increasingly Turning On Disclosure Issues -Even where common sense dictates otherwise -Enablement Less of a Concern- now, focus is on sufficiency of disclosure in order to support breadth of claims Solution is to focus on description of the invention, provide examples of each claim element and have as many examples (including prophetic) in the specification as time and cost measures would dictate.

28. Inherency Issues -Rejection of Application Increasingly Turning on Inherency of Disclosure in Cited Prior Art. -That Art Inherently Teaches Claimed Invention -Examiners shifting burden onto Applicant to show that prior art does not disclose claimed invention Solution is to conduct experimentation to evidence that art does not inherently disclose invention, or Add element or claim limitation to claim that is not disclosed by the prior art- e.g. diagnostic step; patient step (patient in need thereof)

29. Obviousness (Inventive Step) Increasingly, the obviousness rejections are made using prior art disclosures that are somewhat tenuous. Examiners increasingly requiring evidence of unexpected results. -experimental evidence of unexpected results often required within the framework of claim limitations. Arguments regarding non-obviousness less likely to be dispositive. Good approach- is to look for prior art that “teaches away”. This makes experimental evidence of patentability less important and allows for easier path to patentability.

30. Path to Patentability- No change in difficulty of allowance near term, but questions emerge as to impact of AIA on patentability questions- aside from the change in prior art issues associated with examination. In other words, will there be a change in examination policy to go along with change in law. Advice- If possible, try to file patent applications prior to March 16, 2013 to avoid impact of new law.