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America Invents Act: Prior Art Professor Margo A. Bagley University of Virginia School of Law.

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1 America Invents Act: Prior Art Professor Margo A. Bagley University of Virginia School of Law

2 Prior Art Still defined by 35 U.S.C. §102, but (a) – (g) have been replaced with new (a) – (d) New provisions: (a) defines prior art (b) provides exceptions to defined prior art (c) incorporates CREATE ACT provisions (d) provides way to determine when patents and published applications are effective as prior art

3 May be copied or otherwise used for educational purposes. 3 §102 Conditions for patentability; novelty and loss of right to patent A person shall be entitled to a patent unless – (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, [35 USC 102(a)] or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or (c) he has abandoned the invention, or (d) the invention was first patented or caused to be patented, or was the subject of an inventor's certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor's certificate filed more than twelve months before the filing of the application in the United States, or (e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or (f) he did not himself invent the subject matter sought to be patented, or (g) (1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person's invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.

4 May be copied or otherwise used for educational purposes. 4 §102 Conditions for patentability; novelty and loss of right to patent A person shall be entitled to a patent unless – (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, [35 USC 102(a)] or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or (c) he has abandoned the invention, or (d) the invention was first patented or caused to be patented, or was the subject of an inventor's certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor's certificate filed more than twelve months before the filing of the application in the United States, or (e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or (f) he did not himself invent the subject matter sought to be patented, or (g) (1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person's invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.

5 §102 Conditions for patentability; novelty A person shall be entitled to a patent unless – (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or (e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, May be copied or otherwise used for educational purposes. 5 Pre-AIA §102(b) Pre-AIA §102(e)

6 Two §102(a) Categories: (1) Public and (2) Patent-Filing Disclosures 6 Under new §102(a), prior art is (may be?) confined to disclosures made available to the public prior to the inventor’s patent filing and earlier patent filings of others that subsequently became public (published or issued). May be copied or otherwise used for educational purposes. §102(a)(2) Patent-Filing Disclosures [U.S. & U.S. PCT] §102(a)(1): Public Disclosures

7 May be copied or otherwise used for educational purposes. 7 Geographic Limitations Removed Public Accessibility Required Effective Filing Date Added Pre-AIA §102(b) Post-AIA §102(a)(1) (b) The invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or in this or a foreign country in this country (b) The invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or in this or a foreign country in this country (b) The invention was patented or described in a printed publication in this or a foreign country or in public use, or on sale, in this country, or otherwise available to the public more than one year prior to the date of the application for patent in the United States, or (b)in this or a foreign country in this countrymore than one year prior to the date of the application for patent in the United States (b) (a)(1) The invention was patented or described in a printed publication in this or a foreign country or in public use, or on sale, in this country, or otherwise available to the public more than one year prior to the date of the application for patent in the United States before the effective filing date of the claimed invention, or

8 New §102(a)(1) retains some language from existing §102(b) – 8May be copied or otherwise used for educational purposes. “Effective filing date” and “claimed invention” are defined terms in §100. The new requirement “or otherwise available to the public” takes all of existing §102(b) prior art, and (1) limits what would have been prior art through a public accessibility limitation and (2) expands what was formerly prior art by removing the “in this country” limitation. New §102(a)(1) differs from existing §102(b) by using “effective filing” date in lieu of “one year” date. (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...

9 “Secret/Non-informing” Prior Art Gone? Metallizing Eng. v. Kenyon: secret commercial use of an invention by the inventor is a public use under 102(b) and bars entitlement to a patent if occurs more than one year before U.S. filing date. Egbert v. Lippman: A use of the invention that does not inform the public about the invention is a public use under 102(b) and bars entitlement to a patent if occurs more than one year before U.S. filing date. AIA legislative history indicates neither prior art under new 102(a)

10 Understanding new §102 prior art requires starting with §100 New §100 provides definitions for– – “claimed invention” – “effective filing date” 10May be copied or otherwise used for educational purposes.

11 11 May be copied or otherwise used for educational purposes.

12 What is needed to make a disclosure “otherwise available to the public”? New term of art in U.S. patent law. Legislative history: “in section 102 the ‘in this country’ limitation as applied to ‘public use’ and ‘on sale’ is removed, and the phrase ‘available to the public’ is added to clarify the broad scope of relevant prior art, as well as to emphasize the fact that it must be publicly accessible.” * *- pp , House Report to Accompany H.R (June 1, 2011). 12May be copied or otherwise used for educational purposes.

13 New §102(a)(2) retains some language from existing §102(e) – 13May be copied or otherwise used for educational purposes. “Deemed published” incorporates §374 PCT filings. “effectively filed” eliminates Hilmer. “Issued under §151” references U.S. patent filings. “Names another inventor” is synonym for “application … by another.” New §102(a)(2) references patents first. (a) Novelty; Prior Art. - A person shall be entitled to a patent unless - (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.

14 “Deemed published” accounts for U.S.- designating PCT patent applications §374. Publication of international application The publication under the treaty defined in section 351(a) of this title, of an international application designating the United States shall be deemed a publication under section 122(b), except as provided in sections 102(e) and 154(d) of this title. * *- Amended under Sections 3(g)(4) and 20(j)(1) of the AIA. 14May be copied or otherwise used for educational purposes.

15 “Effectively filed” defined in §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 patent or application- – ‘‘(1) if paragraph (2) does not apply, as of the actual filing date of the patent or the application for patent” – “(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 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 15May be copied or otherwise used for educational purposes.

16 AIA 102(b) Exceptions to 102(a) Prior art

17 17 Prior- disclosures as prior art are subject to two separate “Exceptions.” Inventor-friendly and collaboration-friendly features of U.S. law codified as “exceptions” to prior art – one set for prior disclosures and a second for prior-filed patent filings of others. Prior-filed, later-published U.S./U.S. PCT patent filings are subject to three separate “Exceptions.” §102(b)(1) exceptions deal only with §102(a)(1) prior art. §102(b)(2) exceptions deal only with §102(a)(2) prior art. May be copied or otherwise used for educational purposes.

18 102(b)(1) 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[102(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 or indirectly from the inventor or a joint inventor” 18May be copied or otherwise used for educational purposes.

19 A disclosure under §102(a)(1) is excepted 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 or indirectly from the inventor or a joint inventor” 19 A subsequent disclosure by anyone else is not prior art with respect to subject matter in an inventor’s earlier public disclosure. §102(b)(1)(B) Public disclosures not more than 1- year before “effective filing date” – The public disclosure represents the inventor’s own work – §102(b)(1)(A) May be copied or otherwise used for educational purposes.

20 A disclosure shall not be prior art to a claimed invention under [102(a)(2)] if: (A)“the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor” or (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.” 20 * 102(b)(2) May be copied or otherwise used for educational purposes.

21 Earlier (not-yet-public) patent filings NOT prior art as of when effectively filed if … 102(b)(1): An earlier patent filing under §102(a)(2) is excepted if: (A)“the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor“ or (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.” 21 Earlier patent filings of others to the extent of inventor’s public disclosures that precede those patent filings. The inventor’s co-workers and research collaborators patent filings. §102(b)(2)(B) §102(b)(2)(A) §102(b)(2)(C) The inventor’s own work. May be copied or otherwise used for educational purposes.

22 Pat. App. Filed 12 mos. Susan’s U.S. Patent Susan 2 nd ITF Public use How 2 nd to file but 1 st to disclose can beat 1 st to file Disclosure “by or obtained from” Inventor Susan Thomas FITF 22 § 102(b)(1)(A) § 102(b)(2)(B) Tom’s US application published Susan avoids public use through §102(b)(1)(A); Susan’s public use avoids Thomas’s publication through §102(b)(2)(B) and defeats Thomas through § 102(a)(1); First inventor to file loses because other inventor disclosed first. § 102(a)(1)

23 AIA 102(c)

24 24 The CREATE Act from 2004 remains substantively unchanged, except that statute is now clarified that parties to the joint research agreement must have made both the claimed invention and the prior-filed subject matter that is excluded as prior art. Additionally, the test for applicability is that the joint research agreement be in effect as of the effective filing for the claimed invention with respect to which the exclusion from prior art applies. §102(c) May be copied or otherwise used for educational purposes.

25 25 The CREATE Act from 2004 remains substantively unchanged, except that statute is now clarified that parties to the joint research agreement must have made both the claimed invention and the prior-filed subject matter that is excluded as prior art. Additionally, the test for applicability is that the joint research agreement be in effect as of the effective filing date for the claimed invention with respect to which the exclusion from prior art applies. §102(c) May be copied or otherwise used for educational purposes. Application must name parties to JRA. Claimed invention must be made pursuant to activities within the scope of the JRA. JRA must be executed before the effective filing date and claimed invention and subject matter excluded from prior art must be made (or developed) by parties to the JRA.

26 AIA 35 USC §103

27 May be copied or otherwise used for educational purposes. 27 Sec Conditions for patentability; non-obvious subject matter (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. (b)(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if – (A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and (B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person. (2) A patent issued on a process under paragraph (1) – (A) shall also contain the claims to the composition of matter used in or made by that process, or (B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154. (3) For purposes of paragraph (1), the term “biotechnological process” means – (A) a process of genetically altering or otherwise inducing a single– or multi-celled organism to – (i) express an exogenous nucleotide sequence, (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or (iii) express a specific physiological characteristic not naturally associated with said organism; (B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and (C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B). (c)(1) Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the invention was made, owned by the same person or subject to an obligation of assignment to the same person. (2) For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person if— (A) the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made; (B) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and C) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement. (3) For purposes of paragraph (2), the term “joint research agreement” means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.

28 May be copied or otherwise used for educational purposes. 28 Sec Conditions for patentability; non-obvious subject matter (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. (b)(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if – (A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and (B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person. (2) A patent issued on a process under paragraph (1) – (A) shall also contain the claims to the composition of matter used in or made by that process, or (B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154. (3) For purposes of paragraph (1), the term “biotechnological process” means – (A) a process of genetically altering or otherwise inducing a single– or multi-celled organism to – (i) express an exogenous nucleotide sequence, (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or (iii) express a specific physiological characteristic not naturally associated with said organism; (B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and (C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B). (c)(1) Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the invention was made, owned by the same person or subject to an obligation of assignment to the same person. (2) For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person if— (A) the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made; (B) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and C) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement. (3) For purposes of paragraph (2), the term “joint research agreement” means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.

29 (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. (a) A patent may not be obtained notwithstanding that though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the claimed invention subject matter sought to be patented and the prior art are such that the claimed invention subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. A patent may not be obtained notwithstanding that though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the claimed invention subject matter sought to be patented and the prior art are such that the claimed invention subject matter as a whole would have been obvious before the effective filing date of the claimed invention at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. May be copied or otherwise used for educational purposes. 29 Simplify, Clarify Language Add the Effective Filing Date Pre-AIA §103(a) Post-AIA §103 The terms “claimed invention” and “effective filing date” are now defined in §100; “disclosed” is now explicitly used in §102 as a generic term inclusive of “described.”

30 Conclusions Prior art: – many new features, terms – Several issues for court to resolve

31 Acknowledgements Special thanks to Tom Irving, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (along with Joe Matal, Senate Judiciary Counsel for Senator Jon Kyl; and Bob Armitage, Senior VP and General Counsel, Eli Lilly); for sharing slide content

32 32 Is It a Public Use Under current 102(b)? ActorInforming Use Non- Informing Use Secret Use ApplicantYes Pennock v. Dialogue Yes Egbert v. Lippman Yes Metallizing Eng’g Third PartyYes Elec.Stor. Battery v. Shimadzu Yes Abbott Labs. v. Geneva No Gore v. Garlock

33 33 Is It a Public Use Under AIA 102(a)? ActorInforming Use Non- Informing Use Secret Use ApplicantYes Pennock v. Dialogue No Egbert v. Lippman No Metallizing Eng’g Third PartyYes Elec.Stor. Battery v. Shimadzu No Abbott Labs. v. Geneva No Gore v. Garlock

34 34 The House Report (footnote 20, p. 43 references the Kyl statement at S1368-S1371 (March 8, 2011) exhaustively sets forth the rationale for the “public accessibility” criteria to be used to determine §102 prior art. Uses an existing body of well- developed law in preference to adopting a new legal standard. May be copied or otherwise used for educational purposes.

35 Arguments in favor of AIA eliminating Metallizing Engr and Egbert: -if 102(a)(1), were not read to eliminate secret-activities prior art, it would impose forfeiture of a patent for an invention that was only sold or disclosed, the day before patent filing, to one person, who promptly took that secret to his grave while at the same time, 102(b)(1)’s grace period would allow the patenting of an invention that was sold or otherwise made available to the whole world for an entire year. -Post grant review is explicitly limited to FTF patents because first-to- invent patents, among other things, raise “secret-prior-art issues that would be difficult to address in an administrative proceeding.” (Cong. Rec.), so if Metallizing is not gone, PGR would have to deal with secret prior art issues. -limitations in Sec. 18 business methods review program that limit prior art for FTI patents to publicly available prior art, but do not make any carve-outs for FTI patents (since they would not be subject to any secret prior art anyway)

36 Arguments that AIA did not eliminate Metallizing or Egbert: 1) It is a standard canon of statutory construction that reenactment of statutory language with a known legal meaning continues the known meaning. (2) While one sentence in a Senate colloquy does support the opposite view, the entirety of that colloquy was devoted to discussing the grace period. Nothing said there suggested that Congress wanted to undo a fundamental principle of patent law. 3) Another accepted canon of statutory construction is that Congress does not “hide elephants in mouseholes.” Overturning two centuries of consistent law would be a big elephant to hide in a colloquy. (4) Remarks in legislative history are not the statutory text. Indeed, remarks are not always reliable because the speakers could be focusing on a different issue (as is true here).

37 37 In re Wertheim is gone; earlier patent filings not subject to “enablement” before filing date of claimed invention May be copied or otherwise used for educational purposes. Filing/Publication Dates (Roman Numerals) A + C + D Provisional Filings Nonprovisional Publishes IV A+B+CA+B+C III A+BA+B II A I V A effectively filed on I. C effectively filed on III. D effectively filed on IV. B becomes prior art when published (V). A, B, C, and D = separate embodiments In re Wertheim, 646 F.2d 527 (CCPA 1981) limited what could be prior art, for a description appearing in a U.S. patent as of its filing date, to subject matter that was sufficiently enabled so that a patent could be issued on that subject matter on the day of filing.


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