112TH CONGRESS
`1st Session
`
`"
`
`HOUSE OF REPRESENTATIVES
`
`!
`
`REPT. 112–98
`Part 1
`
`AMERICA INVENTS ACT
`
`JUNE 1, 2011.—Committed to the Committee of the Whole House on the State of
`the Union and ordered to be printed
`
`Mr. SMITH of Texas, from the Committee on the Judiciary,
`submitted the following
`
`R E P O R T
`
`together with
`
`DISSENTING VIEWS AND ADDITIONAL VIEWS
`
`[To accompany H.R. 1249]
`
`[Including cost estimate of the Congressional Budget Office]
`The Committee on the Judiciary, to whom was referred the bill
`(H.R. 1249) to amend title 35, United States Code, to provide for
`patent reform, having considered the same, reports favorably there-
`on with an amendment and recommends that the bill as amended
`do pass.
`
`CONTENTS
`
`Page
`1
`......................................................................................................
`The Amendment
`38
`Purpose and Summary ............................................................................................
`40
`Background and Need for the Legislation .............................................................
`57
`Hearings ...................................................................................................................
`58
`Committee Consideration ........................................................................................
`58
`Committee Votes ......................................................................................................
`63
`Committee Oversight Findings ...............................................................................
`63
`New Budget Authority and Tax Expenditures ......................................................
`63
`Congressional Budget Office Cost Estimate ..........................................................
`73
`Performance Goals and Objectives .........................................................................
`73
`Advisory on Earmarks .............................................................................................
`73
`Section-by-Section Analysis
`....................................................................................
`85
`Agency Views ...........................................................................................................
`89
`Changes in Existing Law Made by the Bill, as Reported .....................................
`Dissenting Views
`..................................................................................................... 162
`Additional Views ...................................................................................................... 163
`
`99–006
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`should not have issued; and reducing unwarranted litigation costs
`and inconsistent damage awards.
`The purpose of the ‘‘America Invents Act,’’ as reported by the
`Committee on the Judiciary, is to ensure that the patent system in
`the 21st century reflects the constitutional imperative. Congress
`must promote innovation by granting inventors temporally limited
`monopolies on their inventions in a manner that ultimately bene-
`fits the public through the disclosure of the invention to the public.
`The legislation is designed to establish a more efficient and stream-
`lined patent system that will improve patent quality and limit un-
`necessary and counterproductive litigation costs.
`If the United States is to maintain its competitive edge in the
`global economy, it needs a system that will support and reward all
`innovators with high quality patents. The Committee has taken
`testimony from and its members have held meetings with inter-
`ested parties that have different and often conflicting perspectives
`on the patent system. The Committee has taken all of those views
`into consideration, and drafted and then amended the ‘‘America In-
`vents Act’’ to balance the competing interests. The legislation or-
`dered reported by the Committee on a vote of 32–3 is a consensus
`approach that will modernize the United States patent system in
`significant respects.
`Background and Need for the Legislation
`First Inventor to File
`The ‘‘America Invents Act’’ creates a new ‘‘first-inventor-to-file’’
`system. Every industrialized nation other than the United States
`uses a patent priority system commonly referred to as ‘‘first-to-file.’’
`In a first-to-file system, when more than one application claiming
`the same invention is filed, the priority of a right to a patent is
`based on the earlier-filed application. The United States, by con-
`trast, currently uses a ‘‘first-to-invent’’ system, in which priority is
`established through a proceeding to determine which applicant ac-
`tually invented the claimed invention first. Differences between the
`two systems arise in large part from the date that is most relevant
`to each respective system. In a first-to-file system, the filing date
`of the application is most relevant;10 the filing date of an applica-
`tion is an objective date, simple to determine, for it is listed on the
`face of the patent. In contrast, in a first-to-invent system, the date
`the invention claimed in the application was actually invented is
`the determinative date. Unlike the objective date of filing, the date
`someone invents something is often uncertain, and, when disputed,
`typically requires corroborating evidence as part of an adjudication.
`There are significant, practical differences between the two sys-
`tems. Among them is the ease of determining the right to a claimed
`invention in the instance in which two different people file patent
`applications for the same invention. In a first-to-file system, the ap-
`plication with the earlier filing date prevails and will be awarded
`the patent, if one issues. In the first-to-invent system, a lengthy,
`complex and costly administrative proceeding (called an ‘‘inter-
`ference proceeding’’) must be conducted at the United States Patent
`and Trademark Office (‘‘USPTO’’) to determine who actually in-
`
`10 When the term ‘‘filing date’’ is used herein, it is also meant to include, when appropriate,
`the effective filing date, i.e., the earliest date the claim in an application-claims priority.
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`vented first.11 Interference proceedings can take years to complete
`(even if there is no appeal to the United States Court of Appeals
`for the Federal Circuit), cost hundreds of thousands of dollars, and
`require extensive discovery.12 In addition, because it is always pos-
`sible that an applicant could be involved in an interference pro-
`ceeding, companies must maintain extensive recording and docu-
`ment retention systems in case they are later required to prove the
`date they invented the claimed invention.
`Another important difference between the two systems is that in
`some first-to-file systems, prior art can include the inventor’s own
`disclosure of his invention prior to the filing date of his application.
`Such systems do not provide the inventor any grace period during
`which time he is allowed to publish his invention without fear of
`its later being used against him as prior art. The Committee heard
`from universities and small inventors, in particular, about the im-
`portance of maintaining that grace period in our system.13 They ar-
`gued that the grace period affords the necessary time to prepare
`and file applications, and in some instances, to obtain the nec-
`essary funding that enables the inventor to prepare adequately the
`application. In addition, the grace period benefits the public by en-
`couraging early disclosure of new inventions, regardless of whether
`an application may later be filed for a patent on it.
`Numerous organizations, institutions, and companies have advo-
`cated that the U.S. adopt a first-to-file system similar to those used
`in the rest of the world.14 The National Academy of Sciences made
`a similar recommendation after an extensive study of the patent
`system.15 When the United States patent system was first adopted,
`inventors did not typically file in other countries. It is now common
`for inventors and companies to file for protection in several coun-
`tries at the same time.16 Thus, United States applicants, who also
`
`11 See 35 U.S.C. § 135.
`12 See, e.g., Robert W. Pritchard, The Future is Now—The Case for Patent Harmonization, 20
`N.C. J. Int’l L. & Com. Reg. 291, 313 (1995).
`13 See, e.g., Perspectives on Patents: Harmonization and Other Matters: Hearing Before the
`Subcomm. on Intellectual Prop. of the Senate Comm. on the Judiciary, 109th Cong. (2005) (state-
`ment of Charles E. Phelps, Provost, University of Rochester, on behalf of the Association of
`American Universities); Patent Law Reform: Injunctions and Damages: Hearing Before the
`Subcomm. on Intellectual Prop. of the Senate Comm. on the Judiciary, 109th Cong. (2005) (state-
`ment of Carl Gulbrandsen, Managing Director, Wisconsin Alumni Research Foundation
`(WARF)); Perspective on Patents: Hearing Before the Subcomm. on Intellectual Prop. of the Sen-
`ate Comm. on the Judiciary, 109th Cong. (2005) (statement of William Parker, Diffraction, Ltd.).
`14 See, e.g., Perspectives on Patents: Harmonization and Other Matters: Hearing Before the
`Subcomm. on Intellectual Prop. of the Senate Comm. on the Judiciary, 109th Cong. (2005) (state-
`ment of Gerald J. Mossinghoff, Former Assistant Secretary of Commerce and Commissioner of
`Patents and Trademarks); Perspectives on Patents: Harmonization and Other Matters: Hearing
`Before the Subcomm. on Intellectual Prop. of the Senate Comm. on the Judiciary, 109th Cong.
`(2005) (statement of Q. Todd Dickinson, Former Under Secretary of Commerce for Intellectual
`Property and Director of the United States Patent and Trademark Office); Patent Law Reform:
`Injunctions and Damages: Hearing Before the Subcomm. on Intellectual Prop. of the Senate
`Comm. on the Judiciary, 109th Cong. (2005) (statement of Jeffrey P. Kushan, Partner, Sidley
`Austin Brown & Wood, LLP); Patent Law Reform: Injunctions and Damages: Hearing Before the
`Subcomm. on Intellectual Prop. of the Senate Comm. on the Judiciary, 109th Cong. (2005) (state-
`ment of Mark A. Lemley, Professor, Stanford Law School); Perspectives on Patents: Hearing Be-
`fore the Subcomm. on Intellectual Prop. of the Senate Comm. on the Judiciary, 109th Cong.
`(2005) (statement of Robert A. Armitage, Senior Vice President and General Patent Counsel, Eli
`Lilly and Company); Perspectives on Patents: Hearing Before the Subcomm. on Intellectual Prop.
`of the Senate Comm. on the Judiciary, 109th Cong. (2005) (statement of Michael K. Kirk, Execu-
`tive Director, American Intellectual Property Law Association).
`15 See NAS Report at 124; see also Perspectives on Patents: Hearing Before the Subcomm. on
`Intellectual Prop. of the Senate Comm. on the Judiciary, 109th Cong. (2005) (statement of Rich-
`ard C. Levin, Yale University).
`16 See Perspectives on Patents: Harmonization and Other Matters: Hearing Before the
`Subcomm. on Intellectual Prop. of the Senate Comm. on the Judiciary, 109th Cong. (2005) (state-
`Continued
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`want to file abroad, are forced to follow and comply with two dif-
`ferent filing systems. Maintaining a filing system so different from
`the rest of the world disadvantages United States applicants who,
`in most instances, also file in other countries.17 A change is long
`overdue.18
`Drawing on the best aspects of the two existing systems, the
`America Invents Act creates a new ‘‘first-inventor-to-file’’ system.
`This new system provides patent applicants in the United States
`the efficiency benefits of the first-to-file systems used in the rest
`of the world by moving the U.S. system much closer to a first-to-
`file system and making the filing date that which is most relevant
`in determining whether an application is patentable. The new sys-
`tem continues, however, to provide inventors the benefit of the 1-
`year grace period. As part of the transition to a simpler, more effi-
`cient first-inventor-to-file system, this provision eliminates costly,
`complex interference proceedings, because priority will be based on
`the first application. A new administrative proceeding—called a
`‘‘derivation’’ proceeding—is created to ensure that the first person
`to file the application is actually a true inventor. This new pro-
`ceeding will ensure that a person will not be able to obtain a pat-
`ent for the invention that he did not actually invent. If a dispute
`arises as to which of two applicants is a true inventor (as opposed
`to who invented it first), it will be resolved through an administra-
`tive proceeding by the Patent Board. The Act also simplifies how
`prior art is determined, provides more certainty, and reduces the
`cost associated with filing and litigating patents.
`The Act maintains a 1-year grace period for U.S. applicants. Ap-
`plicants’ own publication or disclosure that occurs within 1 year
`prior to filing will not act as prior art against their applications.
`Similarly, disclosure by others during that time based on informa-
`tion obtained (directly or indirectly) from the inventor will not con-
`stitute prior art. This 1-year grace period should continue to give
`U.S. applicants the time they need to prepare and file their appli-
`cations.
`This provision also, and necessarily, modifies the prior-art sec-
`tions of the patent law. Prior art will be measured from the filing
`date of the application and will typically include all art that pub-
`licly exists prior to the filing date, other than disclosures by the in-
`ventor within 1 year of filing. Prior art also will no longer have any
`geographic limitations. Thus, in section 102 the ‘‘in this country’’
`
`ment of Gerald J. Mossinghoff, Former Assistant Secretary of Commerce and Commissioner of
`Patents and Trademarks) .
`17 See Perspectives on Patents: Hearing Before the Subcomm. on Intellectual Prop. of the Senate
`Comm. on the Judiciary, 109th Cong. (2005) (statement of Richard C. Levin, President, Yale
`University, and Mark B. Meyers, Visiting Executive Professor, Management Department at the
`Wharton Business School, University of Pennsylvania), estimating that it costs as much as
`$750,000 to $1 million to obtain worldwide patent protection on an important invention, and
`the lack of harmonization regarding filing systems adds unnecessary cost and delay.
`18 The NAS recommended changing the U.S. to a first-to-file system, while maintaining a
`grace period. See NAS Report at 124–27. See also Patent Reform in the 111th Congress: Legisla-
`tion and Recent Court Decisions: Hearing Before the Senate Comm. on the Judiciary, 111th
`Cong. (2009) (statement of Steven Appleton, Chairman and Chief Executive Officer, Micron
`Technologies, Inc.); Patent Reform in the 111th Congress: Legislation and Recent Court Deci-
`sions: Hearing Before the Senate Comm. on the Judiciary, 111th Cong. (2009) (statement of Phil-
`ip S. Johnson, Chief Patent Counsel, Johnson & Johnson); Patent Reform in the 111th Congress:
`Legislation and Recent Court Decisions: Hearing Before the Senate Comm. on the Judiciary,
`111th Cong. (2009) (statement of Herbert C. Wamsley, Executive Director, Intellectual Property
`Owners Association); Patent Reform in the 111th Congress: Legislation and Recent Court Deci-
`sions: Hearing Before the Senate Comm. on the Judiciary, 111th Cong. (2009) (statement of
`Mark A. Lemley, Professor, Stanford Law School).
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`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. Prior art based on earlier-filed
`United States applications is maintained,19 as is current law’s
`grace period, which will apply to all actions by the patent owner
`during the year prior to filing that would otherwise create § 102(a)
`prior art.20 Sections (and subsections) of the existing statute are re-
`numbered, modified, or deleted consistent with converting to a
`first-inventor-to-file system.21 Finally, the intent behind the CRE-
`ATE Act to promote joint research activities is preserved by includ-
`ing a prior art exception for subject matter invented by parties to
`a joint research agreement. The Act also provides that its enact-
`ment of new section 102(c) of title 35 is done with the same intent
`to promote joint research activities that was expressed in the Coop-
`erative Research and Technology Enhancement Act of 2004 (Public
`Law 108–453), and that section 102(c) shall be administered in a
`manner consistent with such intent.
`Inventor’s oath or declaration
`The U.S. patent system, when first adopted in 1790, con-
`templated that individual inventors would file their own patent ap-
`plications, or would have a patent practitioner do so on their be-
`half. It has become increasingly common for patent applications to
`be assigned to corporate entities, most commonly the employer of
`the inventor.22 In fact, many employment contracts require employ-
`ees to assign their inventions to their employer.23
`Current law still reflects the antiquated notion that it is the in-
`ventor who files the application, not the company-assignee. For ex-
`ample, every inventor must sign an oath as part of the patent ap-
`plication stating that the inventor believes he or she is the true in-
`ventor of the invention claimed in the application.24 By the time an
`application is eventually filed, however, the applicant filing as an
`assignee may have difficulty locating and obtaining every inven-
`tor’s signature for the statutorily required oath. Although the
`USPTO has adopted certain regulations to allow filing of an appli-
`cation when the inventor’s signature is unobtainable,25 many have
`advocated that the statute be modernized to facilitate the filing of
`applications by assignees.26
`The Act updates the patent system by facilitating the process by
`which an assignee may file and prosecute patent applications. It
`
`19 Compare current § 102(e) with new § 102(a)(2).
`20 See generally 157 Cong. Rec. S.1496–97 (daily ed. March 9, 2011), S. 1370–71 (daily ed.
`March 8, 2011).
`21 The Committee does not intend a substantive change by replacing the word ‘‘negatived’’ in
`section 103 of title 35 with ‘‘negated.’’
`22 See John R. Allison & Mark A. Lemley, The Growing Complexity of the United States Patent
`System, 82 B.U. L. Rev. 77, 97 (2002) (study showing that approximately 85% of the patents
`issued between 1996–98 were assigned by inventors to corporations; an increase from 79% dur-
`ing the period between 1976–78).
`23 See Jerry C. Liu, Overview of Patent Ownership Considerations in Joint Technology Develop-
`ment, 2005 Syracuse Sci. & Tech. L. Rep. 1 (2005).
`24 35 U.S.C. § 115.
`25 See 37 C.F.R. § 1.47, which permits an applicant to petition the Director of the USPTO to
`have the application accepted without every inventor’s signature in limited circumstances, e.g.,
`when the inventor cannot be found or refuses to participate in the application.
`26 See Perspectives on Patents: Harmonization and Other Matters: Hearing Before the
`Subcomm. on Intellectual Prop. of the Senate Comm. on the Judiciary, 109th Cong. (2005) (state-
`ment of David Beier, Senior Vice President of Global Government Affairs, Amgen).
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`provides similar flexibility for a person to whom the inventor is ob-
`ligated to assign, but has not assigned, rights to the invention (the
`‘‘obligated assignee’’).
`Section 115 of title 35 is amended to allow a substitute statement
`to be submitted in lieu of an inventor’s oath when either the inven-
`tor (i) is unable to submit an oath, or (ii) is both unwilling to do
`so and under an obligation to assign the invention. If an error is
`discovered, the statement may later be corrected. A savings clause
`is included to prevent an invalidity or unenforceability challenge to
`the patent based on failure to comply with these requirements, pro-
`vided that any error has been remedied. Willful false statements
`remain punishable, however, under Federal criminal laws.27
`Section 118 of title 35 is also amended to make it easier for an
`assignee to file a patent application. The amendment now allows
`obligated assignees—entities to which the inventor is obligated to
`assign the application—to file applications, as well. It also allows
`a person who has a sufficient proprietary interest in the invention
`to file an application to preserve that person’s rights and those of
`the inventor.
`Defense to infringement based on earlier inventor
`Under current law, ‘‘prior user rights’’ may offer a defense to pat-
`ent infringement when the patent in question is a ‘‘business meth-
`od patent’’ 28 and its inventor uses the invention, but never files a
`patent application for it.29 If the same invention is later patented
`by another party, the prior user may not be liable for infringement
`to the new patent holder, although all others may be.
`Many counties include a more expansive prior-user rights regime
`within their first-to-file system. In the United States, this is par-
`ticularly important to high-tech businesses that prefer not to pat-
`ent every process or method that is part of their commercial oper-
`ations. The Act responds to this point by revising US law as fol-
`lows: First, the prior-use defense may be asserted against any pat-
`ent (not just method patents), provided the person asserting the de-
`fense reduced the subject matter of the patent to practice and com-
`mercially used the subject matter at least 1 year before the effec-
`tive filing date of the patent. Second, the defense cannot be as-
`serted if the subject matter was derived from the patent holder or
`persons in privity with the patent holder. And third, the defense
`cannot be asserted unless the prior user both reduced the subject
`matter of the patent to practice and commercially used it at least
`1 year before the effective filing date of the patent or the date that
`the patentee publicly disclosed the invention and invoked the
`§ 102(b) grace period, whichever is earlier.
`This narrow expansion of prior-user rights balances the interests
`of patent holders, including universities, against the legitimate con-
`cerns of businesses that want to avoid infringement suits relating
`to processes that they developed and used prior to another party
`acquiring related patents.
`
`27 See 18 U.S.C. § 1001.
`28 35 U.S.C. § 273(a)(3) states: ‘‘The term ‘method’ means a method of doing or conducting
`business.’’
`29 See 35 U.S.C. § 273.
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`Post-grant review proceedings
`The Act amends ex parte and inter partes reexamination and es-
`tablishes a new post-grant review procedure. Under current law,
`there are two ways to challenge the validity and enforceability of
`a patent that has issued. The patent may be challenged in district
`court litigation or in a reexamination at the USPTO.
`Nearly 30 years ago, Congress created the administrative ‘‘reex-
`amination’’ process, through which the USPTO could review the va-
`lidity of already-issued patents on the request of either the patent
`holder or a third party,30 in the expectation that it would serve as
`an effective and efficient alternative to often costly and protracted
`district court litigation.31 Reexamination requires the USPTO to re-
`view the patent in light of a substantial new question of patent-
`ability not presented during the original examination.32 The initial
`reexamination statute had several limitations that later proved to
`make it a less viable alternative to litigation for evaluating patent
`validity than Congress intended. First, a reexamination request
`could only be based on prior art, and could not be based on prior
`public use or prior sales. Moreover, the requestor could not raise
`any challenge based on § 101 (utility, eligibility) or § 112 (indefinite-
`ness, enablement, written description, best mode). A third party al-
`leging a patent is invalid, therefore, had fewer challenges it could
`raise in the proceeding and, therefore, may instead opt to risk in-
`fringement and litigate the validity of the patent in court. Second,
`in the original reexamination system, the third-party challenger
`had no role once the proceeding was initiated, while the patent
`holder had significant input throughout the entire process. Third,
`a challenger that lost at the USPTO under reexamination had no
`right to appeal an examiner’s, or the Patent Board’s, decision either
`administratively or in court. Restrictions such as these made reex-
`amination a much less favored avenue to challenge questionable
`patents than litigation. Reexamination proceedings are also often
`costly, taking several years to complete,33 and are first conducted
`by examiners and, if the patent is rejected, then by Patent Board
`judges. Thus, many patents must go through two rounds of admin-
`istrative review (one by the examiner, and a second by the Patent
`Board) adding to the length of the proceeding.34
`
`30 See 35 U.S.C. §§ 301–307. A patent holder will typically request reexamination to bolster
`the patent in view of new prior art. A third party may request reexamination to challenge, and
`ultimately invalidate, the patent.
`31 ‘‘Reexamination will permit efficient resolution of questions about the validity of issued pat-
`ents without recourse to expensive and lengthy infringement litigation. . . . The reexamination
`of issued patents could be conducted with a fraction of the time and cost of formal legal pro-
`ceedings and would help restore confidence in the effectiveness of our patent system. . . . It
`is anticipated that these measures provide a useful and necessary alternative for challengers
`and for patent owners to test the validity of united states patents in an efficient and relatively
`inexpensive manner.’’ See H.R. Rep. No. 96–1307(I) at 3 (1980), reprinted in 1980 U.S.C.C.A.N.
`6460, 6462–63.
`32 See 35 U.S.C. § 303.
`33 See Perspectives on Patents: Hearing Before the Subcomm. on Intellectual Prop. of the Senate
`Comm. on the Judiciary, 109th Cong. (2005) (statement of Jon W. Dudas, Undersecretary of
`Commerce for Intellectual Property, Director of the U.S. Patent and Trademark Office), explain-
`ing that ‘‘a large number of reexamination proceedings have been pending before the USPTO
`for more than 4 years,’’ and questioning whether this amount of time is consistent with the stat-
`utory requirement that ‘‘[a]ll reexamination proceedings . . . will be conducted with special dis-
`patch within the Office.’’ See also 35 U.S.C. § 305.
`34 For several years, the standard practice at the USPTO was to assign the reexamination to
`the patent examiner who had originally examined that patent. In addition, the same third-party
`requester could file multiple, serial reexaminations based on the same ‘‘substantial new question
`of patentability,’’ so long as the initial reexamination was not complete. More recently, the
`Continued
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`Congress has responded several times to criticisms of the reex-
`amination system by making amendments to the process.35 In
`1999, Congress created a second reexamination procedure—called
`inter partes reexamination—that gave third-party challengers
`greater input throughout the proceeding by permitting them to re-
`spond to every pleading submitted by the patent holder.36 Congress
`also eventually gave third-party challengers the right to appeal ad-
`verse decisions.37
`As part of the 1999 improvements to reexamination, Congress di-
`rected the USPTO to submit a report to Congress evaluating the
`inter partes reexamination process and making any recommenda-
`tions for changes.38 Initially, the USPTO projected that in the first
`year after the creation of inter partes reexamination, it would re-
`ceive 400 such requests and it projected that by 2004 it would re-
`ceive nearly 600.39 No inter partes reexamination requests were ac-
`tually filed in 2000 and only 27 such requests had been filed by
`2004.40 Over the 5-year period studied by the USPTO, it issued
`900,000 patents and received only 53 requests for inter partes reex-
`amination.41
`The Act expands the category of documents that may be cited in
`a reexamination proceeding to include written statements of the
`patent owner that have been filed in a proceeding before a Federal
`court or the USPTO regarding the scope of claims. This addition
`will counteract the ability of patent owners to offer differing inter-
`pretations of prior art in different proceedings. These written state-
`ments, which include documents, pleadings or evidence from pro-
`ceedings that address the patent owner’s statements, shall not be
`considered for any purpose other than to determine the proper
`meaning of the claims that are the subject of the request in a pro-
`ceeding. Specifically, the Committee does not intend these state-
`ments to be a basis for the institution of a reexamination pro-
`ceeding. Reexaminations will continue to be available only on the
`basis of ‘‘patents or printed publications.’’ 42
`The Act also amends the ex parte reexamination procedure to
`allow the Director to institute a reexamination on the Director’s
`own initiative if a substantial new question of patentability is
`raised by patents or publications.
`from an
`reexamination
`The Act
`converts
`inter partes
`examinational to an adjudicative proceeding, and renames the pro-
`
`USPTO ended some of these procedures, and now reexaminations are handled by a Central Re-
`examination Unit (CRU), and subsequent serial reexamination, based on the same ‘‘substantial
`new question of patentability,’’ is no longer permitted. See, e.g., Manual of Patent Examining
`Procedure (MPEP) §§ 2236 and 2240 (August 2006).
`35 See e.g., 21st Century Dep’t of Justice Appropriations Authorization Act, Pub. L. No. 107–
`273, §§ 13105–06, 13202, 116 Stat. 1758, 1761 (2002) (effective Nov. 2, 2002); American Inven-
`tors Protection Act, Pub.L. 106–113, 113 Stat. 1536, § 1501A et seq. (1999) (creating inter partes
`reexamination) (hereafter referred to as the ‘‘AIPA’’).
`36 See 35 U.S.C. §§ 311–318.
`37 See 35 U.S.C. § 315(b).
`38 AIPA, Pub. L. 106–113, § 4606.
`39 See United States Patent and Trademark Office, Report to Congress on Inter Partes Reexam-
`ination (2004) (hereinafter referred to as ‘‘Report on Inter Partes Reexamination’’), at 4.
`40 Id. at 5.
`41 Id.
`42 The scope of ‘‘patent and printed publication’’ prior art in the amended section 301 is in-
`tended to be coextensive with these terms in current section 102 of the title 35. Further, amend-
`ments made by Section 2 of the Act, which expand and contract the definition of certain other
`forms of prior art, are not intended to change the particular ‘‘patent or printed publication’’ prior
`art, which will continue to be the sole basis for initiating reexamination proceedings.
`
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`NOVARTIS EXHIBIT 2001
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 8 of 19
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