[Congressional Record Volume 157, Number 91 (Thursday, June 23, 2011)]
[Extensions of Remarks]
[Pages E1182-E1185]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                          AMERICA INVENTS ACT

                                 ______
                                 

                               speech of

                            HON. LAMAR SMITH

                                of texas

                    in the house of representatives

                        Wednesday, June 22, 2011

       The House in Committee of the Whole House on the State of 
     the Union had under consideration the bill (H.R. 1249) to 
     amend title 35, United States Code, to provide for patent 
     reform:

  Mr. SMITH of Texas. Madam Chair, I submit: (1) Manager's Statement on 
Supplemental Examination; (2) Manager's Statement on Genetic Test Study 
proposed in the Managers; (3) Statement on the codification of the 
Weldon amendment; (4) Statement on the business method patent 
transitional program; (5) Statement on the PTO fee compromise provision 
in the Manager's amendment; (6) November 2003 letter on the Weldon 
amendment from PTO Director James Rogan; (7) Information on the Weldon 
amendment from the Family Research Council.

Chairman's Floor Remarks/Manager's Statement: Supplemental Examination 
                              in H.R. 1249

       Mr. Speaker, this bill also contains a very important new 
     administrative proceeding available to patent owners, to help 
     improve the quality of issued patents. This new 
     ``Supplemental Examination'' procedure encourages the 
     voluntary and proactive disclosure of information that may be 
     relevant to patent prosecution for the Office to consider, 
     reconsider, or correct. The voluntary disclosure by patentees 
     serves to strengthen valid patents, while narrowing or 
     eliminating patents or claims that should not have been 
     issued. Both of these outcomes promote investment in 
     innovation by removing uncertainty about the scope, validity 
     or enforceability of patents, and thus the use of this new 
     proceeding by patent owners is to be encouraged.
       Subparagraph (C) relating to Supplemental Examination is 
     intended to address the circumstance where, during the course 
     of a supplemental examination or reexamination proceeding 
     ordered under this section, a court or administrative agency 
     advises the PTO that it has made a determination that a fraud 
     on the Office may have been committed in connection with the 
     patent that is the subject of the supplemental examination. 
     In such a circumstance, subparagraph (C) provides that, in 
     addition to any other actions the Director is authorized to 
     take, including the cancellation of any claims found to be 
     invalid under section 307 as a result of the reexamination 
     ordered under this section, the Director shall also refer the 
     matter to the Attorney General. As such, this provision is 
     not intended to impose any obligation on the PTO beyond those 
     it already undertakes, or require it to investigate or 
     prosecute any such potential fraud. Subparagraph (C) is 
     neither an investigative nor an adjudicative provision, and, 
     as such, is not intended to expand the authority or 
     obligation of the PTO to investigate or adjudicate 
     allegations of fraud lodged by private parties.
       Further, any referral under this subjection is not meant to 
     relieve the Director from his obligation to conclude the 
     supplemental examination or reexamination proceeding ordered 
     under this section. It is important for the process to 
     proceed through conclusion of reexamination, so that any 
     claims that are invalid can be properly cancelled.
       The decision to make referrals under subsection (c) is not 
     meant to be delegated to examiners or other agents of the 
     PTO, but rather is a determination that should only be made 
     by the Director himself or herself.
       Supplemental Examination has the potential to play a 
     powerful role in improving patent quality and boosting 
     investment in innovation, economic growth, and job creation. 
     The Director should implement this new authority in a way 
     that maximizes this potential.

[[Page E1183]]

     
                                  ____
            Genetic Test Study in Manager's Amendment (DWS)

       Mr. Speaker, Section 27 of H.R. 1249 requires the Director 
     of the U.S. Patent and Trademark Office to conduct a study on 
     the availability of confirmatory genetic diagnostic testing 
     services in the domestic market, and whether changes to 
     existing patent law are necessary to promote such 
     availability more effectively. Consistent with current law, 
     the genetic inventions that form the basis for such 
     diagnostic tests are eligible for patenting, and may be 
     exclusively licensed by such patent holders for genetic 
     diagnostic purposes.
       This study is intended to provide unbiased, reliable, and 
     empirical information about the existing availability of 
     independent confirmatory genetic diagnostic testing services, 
     as well as patient demand for such testing services, in 
     situations where genetic diagnostic tests are indeed patented 
     and exclusively licensed. Nothing in this section shall be 
     construed as undermining existing patent law in this regard.
       This study is intended to include, but is not limited to, 
     several specific aspects of this issue. Paragraph (1) of 
     subsection (b) requires an assessment of whether the existing 
     level of availability of confirmatory genetic diagnostic 
     testing has an impact on the ability of medical professionals 
     to provide the appropriate standard of medical care to 
     recipients of genetic diagnostic testing, and includes an 
     assessment of the role that patents play in innovation, 
     quality of services, and investment in the genetic diagnostic 
     marketplace. The assessment required by this paragraph also 
     should include empirical information about the extent to 
     which patents have actually been enforced or asserted against 
     the unauthorized practice of confirmatory genetic diagnostic 
     tests, and a comparison of the availability of and demand for 
     confirmatory testing in situations where genetic tests are 
     not patented or are non-exclusively licensed. Paragraph (2) 
     requires the Director to assess the effects of independent, 
     unauthorized confirmatory genetic testing on patent holders 
     or exclusively licensed test providers. The Committee urges 
     the Director to include in this assessment the possible 
     effects of allowing confirmatory testing on authorized 
     providers of non-exclusively licensed genetic diagnostic 
     tests as well, given that such authorized providers may 
     already provide confirmatory testing services. Paragraph (3) 
     requires an evaluation of the impact of patents and exclusive 
     licensing of genetic diagnostic tests on the practice of 
     medicine, including, but not limited to, the ability of 
     medical professionals to interpret test results, and the 
     ability of licensed or unlicensed test providers to 
     provide confirmatory genetic diagnostic tests. The 
     Director's assessment should also include information on 
     the frequency at which confirmatory genetic diagnostic 
     testing currently is performed by medical professionals in 
     instances where an absence of patent protection or non-
     exclusive licensing permits multiple independent test 
     providers. Paragraph (4) requires an assessment of the 
     role that cost and insurance coverage have on access to 
     and provision of confirmatory genetic diagnostic tests 
     today, whether patented or not or exclusively licensed or 
     not, and should include an assessment of whether private 
     and public payors cover such costs and are likely to cover 
     the costs of any expansion of confirmatory testing.''
       Additional Legislative History for the Second Opinion 
     Confirmation Test Study in Managers (H.R. 1249): Additional 
     Information for the Record:
       ``Section 27 requires USPTO to conduct a study on the 
     impact that a lack of independent second opinion testing has 
     on providing medical care to patients and recipients of 
     genetic diagnostic testing, the effect that providing such 
     tests would have on patent holders of exclusive genetic 
     tests, the impact the current exclusive licensing and patents 
     on genetic testing activity has on the practice of medicine, 
     and the role that cost and insurance coverage have on access 
     to genetic diagnostic tests. Nothing in Section 27 shall be 
     construed to reflect any expression by the Congress with 
     respect to the patentability or non-patentability of genetic 
     material or with respect to the validity or invalidity of 
     patents on genetic material.''
                                  ____


                          The Weldon Amendment

       ``None of the funds appropriated or otherwise made 
     available by this act may be used to issue patents on claims 
     directed to or encompassing a human organism.''
       Legislative History:
       The legislation prohibits the use of appropriated funds by 
     the Patent and Trademark Office to issue certain types of 
     claims presented in patent applications. The types of patent 
     claims subject to the prohibition are limited precisely to 
     those that the Patent and Trademark Office, pursuant to its 
     policies, has indicated may not be granted (see M.P.E.P 1st 
     rev. 2105). Specifically, this section operates to prohibit 
     the use of appropriated funds to issue a patent containing 
     claim that encompasses a human individual.
       The Committee recognizes that the economic viability of the 
     biotechnology industry requires that patents be available for 
     the full spectrum of innovation that may be subject to 
     commercialization. The legislation, accordingly does not 
     limit patent eligibility for any type of biotechnology 
     invention that may be commercialized in the United States. 
     The Committee also recognizes that continued innovation in 
     the biomedical and biotechnological fields will lead to new 
     kinds of inventions, and it expects that the overwhelming 
     majority of such inventions will not raise any of the 
     concerns that the present legislation addresses. In 
     particular, nothing in this section should be construed to 
     limit the ability of the PTO to issue a patent containing 
     claims directed to or encompassing:
       1. any chemical compound or composition, whether obtained 
     from animals or human beings or produced synthetically, and 
     whether identical to or distinct from a chemical structure as 
     found in an animal or human being, including but not limited 
     to nucleic acids, polypeptides, proteins, antibodies and 
     hormones;
       2. cells, tissue, organs or other bodily components 
     produced through human intervention, whether obtained from 
     animals, human beings, or other sources; including but not 
     limited to stem cells, stem cell derived tissues, stem cell 
     lines, and viable synthetic organs;
       3. methods for creating, modifying, or treating human 
     organisms, including but not limited to methods for creating 
     embryos through in vitro fertilization, methods of somatic 
     cell nuclear transfer, medical or genetic therapies, methods 
     for enhancing fertility, and methods for implanting embryos;
       4. a nonhuman organism incorporating one or more genes 
     taken from a human organism, including but not limited to a 
     transgenic plant or animal, or animal models used for 
     scientific research.
       As the legislation addresses only the authority of the PTO 
     to expend funds appropriated by this Act, it concerns patents 
     that may issue on applications filed on or after the date of 
     the legislation. The legislation does not create a claim or 
     give rise to any cause of action to limit the rights 
     associated with, or the enforceability of any patent duly 
     granted by the PTO.
                                  ____


  Section 18 (H.R. 1249)--Business Method Patent Transitional Program

       The proceeding would create a cheap and speedy alternative 
     to litigation--allowing parties to resolve these disputes 
     rather than spend millions of dollars that litigation now 
     costs. In the process, the proceeding would also prevent 
     nuisance or extortion litigation settlements.
       Business methods were generally not patentable in the 
     United States before the late 1990s, and generally are not 
     patentable elsewhere in the world, but the Federal Circuit 
     (in what was an activist decision) created a new class of 
     patents in its 1998 State Street decision.
       In its 2010 decision in Bilski v. Kapoos, the U.S. Supreme 
     Court clamped down on the patenting of business methods and 
     other patents of poor quality.
       It is likely that most if not all the business method 
     patents that were issued after State Street are now invalid 
     under Bilski. There is no sense in allowing expensive 
     litigation over patents that are no longer valid.
       This provision is strongly supported by community banks, 
     credit unions and other institutions that are an important 
     source of lending to homeowners and small businesses. Money 
     spent litigating over invalid business-method patents, or 
     paying nuisance settlements, cannot be loaned to Americans to 
     purchase new homes and start new businesses.
       Resolving the validity of these patents in civil litigation 
     typically costs about $5-to-$10 million per patent. Resolving 
     the validity of these patents through the bill's 
     administrative proceeding costs much less.
       Moreover, the proceeding allows business-method patents to 
     be reviewed by the experts at the Patent Office under the 
     correct (Bilski) standard.
       To use this proceeding, a challenger must make an up-front 
     showing to the PTO of evidence that the business-method 
     patent is more likely than not invalid. This is a high 
     standard. Only the worst patents, which probably never should 
     have been issued, will be eligible for review in this 
     proceeding.
       Additionally any argument about this provision and 
     Constitutionality is simply a red herring. Congress has the 
     authority to create administrative proceedings to review the 
     validity of existing patents. We have done it before and we 
     will be doing it in the future.
       This issue has been litigated and rejected by the courts, 
     when Congress created ex parte reexam in 1980. Ex parte 
     reexam was applied to all existing patents when that system 
     was created. In Patlex Corp. v. Mossinghoff, the Federal 
     Circuit rejected the argument that applying a new system of 
     administrative review to existing patents is a taking. The 
     same logic applies to this provision.
       Never in the history of U.S. patent law has it been held, 
     after a patent claim was determined to be invalid because it 
     covered unprotectable subject matter, that the owner of the 
     patent was nevertheless entitled to compensation on the basis 
     of that invalid claim.
       This section only creates a new mechanism for reviewing the 
     validity of business-method patents. It does not alter the 
     substantive law governing the validity of those patents. 
     Under settled precedent, the transitional review program is 
     absolutely constitutional.
       It is wrong and offensive for this provision to be referred 
     to as a bail-out. The program does not give one cent to any 
     private party and the costs of the proceeding are required to 
     be fully recouped through the fee charged

[[Page E1184]]

     for initiating the proceeding. It is a necessary program to 
     allow the PTO to fix mistakes that occurred in light of an 
     activist judicial decision in the 1998 State Street 
     decision that created this new patentable subject matter 
     without Congress' approval.
       This bill will provide the patent office with a fast, 
     precise vehicle to review low quality business method 
     patents, which the Supreme Court has acknowledged are often 
     abstract and overly broad.
       And it bears repeating that defendants cannot even start 
     this program unless they can persuade a panel of judges at 
     the outset of the proceeding that it is more likely than not 
     that the patent is invalid. This is a high threshold, which 
     requires the challenger to present his best evidence and 
     arguments at the outset. Very few patents that undergo this 
     review are likely to be valid patents.
       Specifically, the bill's provision applies to patents that 
     describe a series of steps used to conduct every day business 
     applications in the financial products and retail service 
     space. These are patents that can be and have been asserted 
     against all types of businesses--from community banks and 
     credit unions to retailers like Walmart, Bed Bath & Beyond, 
     Best Buy, J.C. Penney, Staples and Office Max to other 
     companies like Dr. Pepper Snapple Group, UPS, Hilton, AT&T, 
     Facebook, Frito-Lay, Google, Marriott, Walt Disney, Delta 
     Airlines and YouTube.
       This provision is not tied to one industry or sector of the 
     economy--it affects everyone. For example, this program would 
     allow the Patent Office to decide whether to review patents 
     for business methods related to:
       Printing ads at the bottom of billing statements
       Buying something online and picking it up in the store
       Re-ordering checks online
       Converting a IRA to a Roth IRA
       Getting a text message when you use your credit card
       Those who argue that this provision is a Wall Street 
     bailout are just plain wrong. This is about questionable 
     patents and the frivolous litigation that results from them. 
     This provision is important legal reform, supported by the 
     U.S. Chamber of Commerce and is important for American job 
     creators.
                                  ____


           PTO Fee Diversion Compromise (H.R. 1249 Managers)

       By giving USPTO access to all its funds, the Manager's 
     Amendment supports the USPTO's efforts to improve patent 
     quality and reduce the backlog of patent applications. To 
     carry out the new mandates of the legislation and reduce 
     delays in the patent application process, the USPTO must be 
     able to use all the fees it collects.
       The language in the Manager's Amendment reflects the intent 
     of the Judiciary Committee, the Appropriations Committee, and 
     House leadership to end fee diversion. USPTO is 100% funded 
     by fees paid by inventors and trademark filers who are 
     entitled to receive the services they are paying for. The 
     language makes clear the intention not only to appropriate to 
     the USPTO at least the level requested for the fiscal year 
     but also to appropriate to the USPTO any fees collected in 
     excess of such appropriation.
       Providing USPTO access to all fees collected means 
     providing access at all points during that year, including in 
     case of a continuing resolution. Access also means that 
     reprogramming requests will be acted on within a reasonable 
     time period and on a reasonable basis. It means that future 
     appropriations will continue to use language that guarantees 
     USPTO access to all of its fee collections.
                                  ____

         United States Patent and Trademark Office, Under 
           Secretary of Commerce for Intellectual Property and 
           Director of the U.S. Patent and Trademark office,
                                                   Alexandria, VA.
     Hon. Ted Stevens,
     Chairman, Committee on Appropriations, U.S. Senate, 
         Washington, DC.
       Dear Mr. Chairman: Thank you for the opportunity to present 
     the Administration's position on the Weldon amendment adopted 
     by the House during consideration of H.R. 2799, the Commerce-
     Justice-State Appropriations bill FY 2004, and the effect it 
     would have on the United States Patent and Trademark Office 
     (USPTO) policy on patenting living subject matter. For the 
     reasons outlined below, we view the Weldon amendment as fully 
     consistent with USPTO's policy on the non-patentability of 
     human life-forms.
       The Weldon Amendment would prohibit the U.S. Patent and 
     Trademark Office from issuing any patent ``on claims directed 
     to or encompassing a human organism.'' The USPTO understands 
     the Weldon Amendment to provide unequivocal congressional 
     backing for the long-standing USPTO policy of refusing to 
     grant any patent containing a claim that encompasses any 
     member of the species Homo sapiens at any stage of 
     development. It has long been USPTO practice to reject any 
     claim in a patent application that encompasses a human life-
     form at any stage of development, including a human embryo or 
     human fetus; hence claims directed to living ``organisms'' 
     are to be rejected unless they include the adjective 
     ``nonhuman.''
       The USPTO's policy of rejecting patent application claims 
     that encompass human life- forms, which the Weldon Amendment 
     elevates to an unequivocal congressional prohibition, applies 
     regardless of the manner and mechanism used to bring a human 
     organism into existence (e.g., somatic cell nuclear transfer. 
     in vitro fertilization, parthenogenesis). If a patent 
     examiner determines that a claim is directed to a human life-
     form at any stage of development, the claim is rejected as 
     non-statutory subject matter and will not be issued in a 
     patent as such.
       As indicated in Representative Weldon's remarks in the 
     Congressional Record of November 5, 2003, the referenced 
     language precludes the patenting of human organisms, 
     including human embryos. He further indicated that the 
     amendment has ``exactly the same scope as the current USPTO 
     policy.'' which assures that any claim that can be broadly 
     construed as a human being, including a human embryo or 
     fetus, is not patentable subject matter. Therefore, our 
     understanding of the plain language of the Weldon Amendment 
     is fully consistent with the detailed statements that the 
     author of the amendment, Representative Weldon, has made in 
     the Congressional Record regarding the meaning and intent of 
     his amendment.
       Given that the scope of Representative Weldon's amendment 
     does not alter the USPTO policy on the non-patentability of 
     human life-forms at any stage of development and is fully 
     consistent with our policy, we support its enactment.
       With best personal regards, I remain
           Sincerely,
                                                   James E. Rogan,
     Under Secretary and Director.
                                  ____

                                                        FRCAction,


                                      Family Research Council.

               Codify the Weldon Ban on Patenting Humans


                  Current Weldon Patent Ban on Humans

       The Weldon Amendment is contained in the annual Commerce, 
     Justice and Science Appropriations bills (CJS) and prevents 
     the patenting of humans. Congress has passed it each year 
     since 2004, and it was included most recently as part of the 
     FY2010 Omnibus (Section 518, Title V, Division B, of the 
     FY2010 Consolidated Appropriations Act, 2010 (H.R. 3288, P.L. 
     111-117)) and extended by the FY2011 Omnibus spending bill 
     (Department of Defense and Full-Year Continuing 
     Appropriations Act, 2011 (H.R. 1473, P.L. 112-10)).
       Weldon Amendment, Section 518: ``None of the friends 
     appropriated or otherwise made available under this Act may 
     be used to issue patents on claims directed to or 
     encompassing a human organism.''


    Codify the Weldon Amendment--Add it to Patent Reform Legislation

       Congress has each year since 2004 passed the Weldon 
     Amendment to prevent any profiting from patents on humans. 
     The Weldon Amendment restricts funds under the Commerce, 
     Justice, Science Appropriations bill from being used by the 
     U.S. Patent and Trademark Office (USPTO) to issue patents 
     directed to ``human organisms.''
       The America Invents Act (H.R. 1249) may authorize the USPTO 
     to pay for the issuance of patents with ``user fees'' instead 
     of with Congressionally appropriated funds. If this funding 
     mechanism becomes law, the Weldon Amendment restriction would 
     not apply since it only covers funds appropriated under the 
     CJS bill. The USPTO could, thereby, issue patents directed to 
     human beings with non-appropriated funds.
       Patenting human beings at any stage of development would 
     overturn the long-standing USPTO policy against issuing such 
     patents. As the Quigg Memo stated in 1987 (see below) a grant 
     of a property right in a human being is unconstitutional, and 
     patents on humans are grounds for rejection.
       The Weldon restriction can be codified by adding a 
     provision to the America Invents Act to ensure that human 
     beings are not patentable subject matter.
       Codifying a ban on patenting of humans would not violate 
     international obligations under the TRIPs agreement with the 
     WTO. The European Union prevents patents on human embryos on 
     the ground that doing so would violate the public order and 
     morality, an exception the TRIPs agreement specifically 
     allows under Article 27, Section 5.


       What the Weldon Patent Amendment Does and Does Not Affect

       The Weldon Amendment does prevent the USPTO from patenting 
     humans at any stage of development, including embryos or 
     fetuses, by preventing patents on claims directed to ``human 
     organisms.''
       The Weldon Amendment's use of the term ``human organism'' 
     does include human embryos, human fetuses, human-animal 
     chimeras, ``she-male'' human embryos, or human embryos 
     created with genetic material from more than one embryo.
       The Weldon Amendment's use of ``human organism'' does not 
     include the process of creating human embryos, such as human 
     cloning, nor does it include non-human organisms, e.g., 
     animals.
       Then Undersecretary James Rogan wrote to Senate 
     Appropriators on November 20, 2003 stating that the Weldon 
     Amendment gave congressional backing to long-standing USPTO 
     policy against patenting humans stating:
       ``The Weldon Amendment would prohibit the U.S. Patent and 
     Trademark Office from issuing any patent ``on claims directed 
     to or encompassing a human organism.'' The USPTO understands 
     the Weldon Amendment to provide unequivocal congressional 
     backing for the long-standing USPTO policy of refusing to 
     grant any patent containing a claim that encompasses any 
     member of the

[[Page E1185]]

     species Homo sapiens at any stage of development. It has long 
     been USPTO practice to reject any claim in a patent 
     application that encompasses a human life-form at any stage 
     of development, including a human embryo or human fetus; 
     hence claims directed to living ``organisms'' are to be 
     rejected unless they include the adjective 'nonhuman.''
       Secretary Rogan concluded: ``The USPTO's policy of 
     rejecting patent application claims that encompass human 
     life-forms, which the Weldon Amendment elevates to an 
     unequivocal congressional prohibition, applies regardless of 
     the manner and mechanism used to bring a human organism into 
     existence (e.g., somatic cell nuclear transfer, in vitro 
     fertilization, parthenogenesis). If a patent examiner 
     determines that a claim is directed to a human life-form at 
     any stage of development, the claim is rejected as non-
     statutory subject matter and will not be issued in a patent 
     as such.''
       The Weldon Amendment does not prevent patents on human 
     cells, genes, or other tissues obtained from human embryos or 
     human bodies.
       Rep. Dave Weldon submitted a statement to the Congressional 
     Record on December 8, 2003 clarifying that the Weldon 
     Amendment would not prevent patents for non-human organisms 
     even with some human genes. Nor would it affect patents for 
     human cells, tissues or body parts, or for methods of 
     creating human embryos.
       Rep. Weldon stated: ``This amendment should not be 
     construed to affect claims directed to or encompassing 
     subject matter other than human organisms, including but not 
     limited to claims directed to or encompassing the following: 
     cells, tissues, organs, or other bodily components that are 
     not themselves human organisms (including, but not limited 
     to, stem cells, stem cell lines, genes, and living or 
     synthetic organs); hormones, proteins or other substances 
     produced by human organisms; methods for creating, modifying, 
     or treating human organisms, including but not limited to 
     methods for creating human embryos through in vitro 
     fertilization, somatic cell nuclear transfer, or 
     parthenogensis; drugs or devices (including prosthetic 
     devices) which may be used in or on human organisms.''
       The Weldon amendment does not ban human stem cell patents, 
     including patents on human embryonic stem cells. ``Stem 
     cells'' are not ``organisms.''
       On December 2, 1998, several scientists supportive of 
     federal funding of human embryonic stem cell research 
     testified before the Senate Subcommittee on Labor, Health and 
     Human Services, and Education Committee on Appropriations 
     that ``stem cells'' are not ``human organisms.'' When asked, 
     Dr. James Thomson who first obtained human embryonic stem 
     cells, and has patents on those stem cell lines, responded: 
     ``They am not organisms and they are not embryos.''
       Despite claims in 2003 that the Weldon amendment in 2003 
     would ban stem cell patents, the USPTO has maintained several 
     embryonic stem cell patents issued previously. The USPTO has 
     also issued several new patents on human embryonic stem cells 
     since 2003, and has issued roughly 300 new patents on 
     pluripotent stout cells. The Weldon amendment only affects 
     patents on human organisms. (Note, the EU recently reaffirmed 
     its rejection of patents on embryonic stem cells, yet, the 
     Weldon amendment does not follow suit).


                         History and Background

       Longstanding United States Patent and Trademark Office 
     (USPTO) policy states that human beings at any stage of 
     development are not patentable subject matter under 35 U.S.C. 
     Section 101. In 1980, the U.S. Supreme Court in Diamond v 
     Chakrabarty expanded the scope of patentable subject matter 
     claiming Congress intended statutory subject matter to 
     ``include anything under the sun that is made by man.'' The 
     USPTO eventually issued patents directed to non-human 
     organisms, including animals. However, the USPTO rejected 
     patents on humans (see below).
       However, as early as 2003 U.S. researchers announced that 
     they created human male-female embryos and reportedly wanted 
     to patent this research (http://www.thenewatlantis.com/
publications/my-mother-the-embryo). The researchers 
     transplanted cells from male embryos into female embryos and 
     allowed them to grow for six days.
       Because of the possibility of court challenges to USPTO 
     policy, Rep. Dave Weldon offered an amendment on July 22, 
     2003 to the CJS Appropriations bill to prevent funding for 
     patents directed to ``human organisms.''
       The Weldon amendment was adopted by voice vote, and was 
     included as Section 634, Title VI of Division B, in the 
     Consolidated Appropriations Act, 2004 (P.L. 108-199). The 
     accompanying report language clarified its scope: ``The 
     conferees have included a provision prohibiting funds to 
     process patents of human organisms. The conferees concur with 
     the intent of this provision as expressed in the colloquy 
     between the provisions sponsor in the House and the ranking 
     minority member of the House Committee on Appropriations as 
     occurred on July 22, 2003, with respect to any existing 
     patents on stem cells.'' (Conference Report 108-401).
       The Weldon amendment has been included each year in the CJS 
     appropriations bill since 2004 and reflected the USPTO policy 
     against patenting humans as outlined in 3 USPTO official 
     documents.
       First, the USPTO published the ``Quigg memo'' in its 
     Official Gazette on January 5, 1993, which was written in 
     1917 stating: ``The Patent and Trademark Office now considers 
     nonnaturally occurring non-human multicellular living 
     organisms, including animals, to be patentable subject matter 
     within the scope of 35 U.S.C. 101. . . . A claim directed to 
     or including within its scope a human being will not be 
     considered patentable subject matter under 35 U.S.C. 101.'' 
     Furthermore, it ``suggests'' that that any claim directed to 
     ``a non-plant multicellular organism which would include a 
     human being within its scope include the limitation `non-
     human' to avoid this ground of rejection.''
       Second, the USPTO policy is also contained in an official 
     media advisory issued on April 2, 1998 in response to news 
     about s patent application directed to a human/non-human 
     chimera. USPTO claimed that patents ``inventions directed to 
     human/non-human chimera could, under certain circumstances, 
     not be patentable because, among other things, they would 
     fail to meet the public policy and morality aspects of the 
     utility requirement.''
       Third, the USPTO policy is contained in the Manual of 
     Patent Examining Procedure (MPEP) section 2105 under 
     ``Patentable Subject Matter.'' The MPEP states that the USPTO 
     ``would now consider nonnaturally occurring, nonhuman 
     multicellular living organisms, including animals, to be 
     patentable subject matter within the scope of 35 U.S.C. 101. 
     If the broadest reasonable interpretation of the claimed 
     invention as a whole encompasses a human being, then a 
     rejection under 35 U.S.C. 101 must be made indicating that 
     the claimed invention is directed to nonstatutory subject 
     matter.''

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