Browsing the aisles of Costco, taking in the consumerism the Christmas has come to denote, my mind was drawn to its jewelry and watch section. As I was feasting my eyes upon baubles and trinkets I have no use for, I recalled the not so recent Ninth Circuit Costco v. Omega which in turn reminded me that Supreme Court is all set to hear the case. What better time to refresh our memory and ponder over the implications of the case ruling?

Costco Wholesale Corporation sold Swiss watches manufactured by Omega S.A. without prior permission from Omega. Omega brought a copyright infringement suit against Costco claiming that Costco’s act of selling watches manufactured by Omega was an infringement of Omega’s copyright protection as afforded by United States laws. Essentially Costco had purchased watches meant for international markets other than the United States (hence the lower price) and sold it in the U.S. at prices lower than offered by other U.S. distributors. Costco sought protection under the first sale doctrine.

The first sale doctrine was first propounded by the Supreme Court in 1908 in the case of Bobbs Merrill Co. v Straus and later included in the US Copyright Act as a limitation on copyright. Briefly the first sale doctrine allows the purchaser to transfer, sell or donate a copyrighted work without permission of the copyright holder once it has been obtained. This implies that the copyright holder relinquishes all rights related to that particular copy once sold so long as no further copies are made by the purchaser. Parallel importation refers to a good that has been produced and sold legally but illegally imported into a country, without the consent of the copyright owner. Thus parallel imported goods are often referred to as ‘grey goods’ because they are produced with the consent of the copyright owner unlike black market goods. This restriction provides that the same material does not compete with itself on price. Consequently geographical product monopolies are set up.

Costco claims that the first sale doctrine is not territorial. The Ninth Circuit held that the first sale doctrine is indeed territorial and does not apply to imported goods manufactured abroad. A similar argument was used in BMG v. Perez where the Ninth Circuit Court of Appeals held that the importation of phonorecords, which were lawfully purchased in Mexico, violated U.S. Copyright Law when they were imported into the United States. The Ninth Circuit pointed out that since copyrights are territorial, U.S. Copyright Law is not applicable outside of the United States and thus, first sale had not occurred in Mexico.

According to the Ninth Circuit §109(a) granted protection of first sale doctrine only to copies legally made and sold in the U.S. Granting protection of first sale doctrine to copies made and sold outside of the U.S. would render § 602 meaningless.

17 U.S.C. § 109(a): Notwithstanding the provisions of section 106(3), the owner of a particular copy or phonorecord lawfully made under this title, or any person authorized by such owner, is entitled, without the authority of the copyright owner, to sell or otherwise dispose of the possession of that copy or phonorecord.

17 U.S.C. § 602(a): Importation into the United States, without the authority of the owner of copyright under this title, of copies or phonorecords of a work that have been acquired outside the United States is an infringement of the exclusive right to distribute copies or phonorecords under section 106, actionable under section 501

In the Quality King case, the product was manufactured and sold in the United States and then re-imported. The manufacturers had already relinquished their rights as soon as the product was sold and shipped outside of the U.S. The Supreme Court reversed the Ninth Circuit Court’s decision and held that “[T]he whole point of the first sale doctrine is that once the copyright owner places a copyrighted item in the stream of commerce by selling it, he has exhausted his exclusive statutory right to control its distribution.”

Returning to the case at hand, it seems odd that while Omega enjoys copyright protection for its “Omega Globe Design” in the U.S., still claims that a copy manufactured in a foreign country enjoys the foreign copyright law, not United States law. The Ninth Circuit decision is extremely narrow in perspective. It does not take into account the economic implications of its decision. It essentially means that copyright holders do not relinquish their rights upon copies sold or given away. There would be no downstream market. Also, manufacturing copies abroad under foreign copyright laws while still enjoying selectively United States copyright protection is what it seems Omega is doing. It seems counter-intuitive that even when using a logo protected by U.S. laws, Omega insists that the articles were manufactured abroad.

The Ninth Circuit gracefully agrees with prior Supreme Court decisions that the first-sale doctrine applies to works manufactured in the U.S. However, what are the factors that decide where an article was manufactured? Would manufacturers shift production units abroad and thus circumvent the first sale doctrine as well as control over the resales in the U.S? What does this portend for the already deteriorating U.S. job market?

In light of the current economic circumstances, the Supreme Court should allot a wider realm of meaning to the first sale doctrine. Players like Omega should be dissuaded from using U.S. protection for logos for articles manufactured abroad and simultaneously putting at a disadvantage the U.S. retailers.

Today’s post is by Guest Barista Shalini Menezes of ::O.bi:t.er: D:ic.t:um.

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Huw G. Hallybone, a Partner at Carpmaels & Ransford, gave a talk at the BIO IP Counsels Committee Conference (IPCC) in Boston last week about allowable subject matter at the EPO.

Article 53

Exceptions to patentability

European patents shall not be granted in respect of:

(a) inventions the commercial exploitation of which would be contrary to “ordre public” or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;

(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;

(c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

Rule 27

Patentable biotechnological inventions

Biotechnological inventions shall also be patentable if they concern:

(a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature;

(b) plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety;

(c) a microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.

Rule 28

Exceptions to patentability

Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:

(a) processes for cloning human beings [drats!, I guess there won’t be two of me];

(b) processes for modifying the germ line genetic identity of human   beings;

(c) uses of human embryos for industrial or commercial purposes;

(d) processes for modifying the genetic identity of animals which   are likely to cause them suffering without any substantial   medical benefit to man or animal, and also animals resulting   from such processes.

Rule 29

The human body and its elements

(1) The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.

(2) An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

(3) The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.

Monsanto v. Cefetra (C-428/08)

Takeaways:

  • Not possible to rely on DNA claims to protect materials incorporating the DNA where the DNA is not able to perform the specific function for which it was patented
  • Appears to abolish absolute protection for DNA as such
Monsanto’s invention relates to gene conferring herbicide resistance in soy bean plants grown in Argentina (where there is no patent protection).  Cefetra imported soymeal into The Netherlands where Monsanto brought action for infringement of NL(EP) patent against Cefetra.
  • Claim 1: Isolated DNA
  • Claim 6: A DNA sequence encoding a Class II EPSPS enzyme selected from the group consisting of SEQ ID NO:3 and SEQ ID NO:5
  • Claim 7: Recombinant, dsDNA
  • Claim 14: Method of producing genetically transformed plants
  • Claims 21/24: Glyphosate tolerant plant cell/plant
  • Claim 28: Method for selectively controlling weeds
Article 9 Biotech Directive: The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material … in which the product is incorporated and in which the genetic information is contained and performs its function.

ECJ’s ruling

Article 9 of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions is to be interpreted as not conferring patent right protection in circumstances such as those of the case in the main proceedings, in which the patented product is contained in the soy meal, where it does not perform the function for which it is patented, but did perform that function previously in the soy plant, of which the meal is a processed product, or would possibly again be able to perform that function after it had been extracted from the soy meal and inserted into the cell of a living organism.

Referral:

Does the protection of a patent on biological material as provided by the Directive, in particular under Article 9, preclude the national patent legislation from conferring (in parallel) absolute protection on the product (the DNA) as such, regardless of whether the DNA performs its function, and must the protection provided under Article 9 therefore be deemed to be exhaustive?

ECJ’s ruling

Article 9 of the Directive effects an exhaustive harmonisation of the protection it confers, with the result that it precludes the national patent legislation from offering absolute protection to the patented product as such, regardless of whether it performs its function in the material containing it.

The EU court case is C-428/08 Monsanto Technology LLC v. Cefetra BV, Cefetra Feed Service BV, Cefetra Futures BV and State of Argentina and Monsanto Technology LLC v. Vopak Agencies Rotterdam BV and Alfred C. Toepfer International GmbH.

Stem Cells G2/06 [WARF]

Claim 1. A cell culture comprising primate embryonic stem cells which (i) are capable of proliferation in vitro [sic] culture for over one year, (ii) maintain a karyotype in which all chromosomes normally characteristic of the primate species are present and are not noticeably altered through culture for over one year, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) are prevented from differentiating when cultured on a fibroblast feeder layer.

Rule 28(c) EPC … forbids the patenting of claims directed to products which – as described in the application – at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, even if the said method is not part of the claims.

Takeaways:

  • Not relevant that methods not involving destruction of embryos might emerge later;
  • Not relevant that the claims did not recite a step requiring destruction of an embryo;
  • Specification made it clear that the method involved such a step; and
  • Relates to embryonic stems not stem cells in general.
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At the BIO IP Counsels Committee Conference (IPCC) in Boston last week, Sandra Wells, VP and Chief IP Counsel of Affymetrix, gave a talk about the evolving patent-eligibility standards for genes.

Earlier, the American Civil Liberties Union (ACLU), the Public Patent Foundation (PUBPAT), and a whole gaggle of others have filed a lawsuit challenging patents cover diagnostic tests for mutations along the genes, known as BRCA1 and BRCA2, which are responsible for most cases of hereditary breast and ovarian cancers.   Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. (09 Civ. 4515). A copy of the decision is here: Myriad Decision (pdf).

On March 29, 2010, the University of Utah and Myriad Genetics lost a U.S. court ruling over some of its patents for detecting inherited breast cancer related to the genes BRCA1 and BRCA2.  The 152-page decision addresses questions about whether human genes should be subject to patent protection.

Wells reviewed the policy arguments against gene patents:

1.  Gene patents:
  • Are not necessary to incentivize gene discovery
  • Are not necessary to incentivize commercialization of gene tests
  • Lead to fewer genetic test providers
  • Cause inflated prices for genetic tests
  • Restrict patient access to genetic tests
  • Lead to lower quality of genetic tests and other genetic technology
  • Stifle basic or applied research into new or improved genetic technologies
  • Create infringement liability for women who donate cancer samples for research
  • Prevent patients from getting a second opinion

2.  The claims preempt all uses of the information the genes contain, regardless of variation or of method used for analysis, i.e., there is no way to design around.

3.  The scope of patentable subject matter should balance reward for research and ensuring opportunity for future innovation, i.e., Myriad is being overcompensated for its contribution.

Are isolated human genes and the comparison of their sequences patentable?

Are the sequences products of nature?  That is:  “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter.” Chakrabarty, 447 U.S. at 309.  But Chakrabarty in contrast found patentable “a new bacterium with markedly different characteristics from any found in nature.”  Is sequencing a gene more like finding a plant in the wild than a newly engineered bacterium?

For composition of matter claims, the purified product must possess “markedly different characteristics” from a product of nature.  Wells noted that the isolated and purified products do not have any functions that they did not have already so the required change is absent.

Question: Is “Isolated DNA” claimed by Myriad “markedly different” from native DNA as it exists in nature?

Judge Sweet’s Opinion: “Isolated DNA” not Patentable.

“In light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences … between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents … render the claimed DNA ‘markedly different.’”

“The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.”

Typically, when the question of patent-eligibility has come up, the Supreme Court  has identified human intervention as the touchstone. Diamond v. Chakrabarty; (“the invention is not nature’s handiwork, but his own”), accord J.E.M. Ag-Supply; Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.N.Y. 1911). (Purified adrenaline so superior to previous adrenal gland extracts so as to be different not just in degree, but in kind).  The invention must have been transformed through human intervention from the natural thing into something that is qualitatively different, new, and man-made.

Wells then proceeded to give an overview of the history of product of nature case law:

  1. American Wood-Paper Co. v. Fibre Disintegrating Co., 90 U.S. 566 (1874) (pure cellulose pulp preparation prepared by novel chemical process held not novel over prior art cellulose pulp preparations made by old process);
  2. Cochrane v. BASF, 111 U.S. 293 (1884)(claimed “artificial alizarine” prepared by new chemical process not novel over prior art impure alizarine extracts from madder root);
  3. American Fruit Growers v. Brogdex Co., 283 U.S. 1 (1931)(Borax-treated citrus fruit is insufficiently changed from natural fruit, and not a manufacture within the meaning of the Patent Act);
  4. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)(claimed inoculate of mutually non-inhibitive root-nodule bacteria held not inventive over preexisting state of the art);
  5. Lab. Corp. v. Metabolite, 548 U.S. 124 (2006)( Breyer., J. dissenting from dismissal as improvidently granted) A diagnostic method correlation claim is an unpatenable discovery of a law of nature.

Wells also noted that some some claims might be invalid under other provisions, for example claim 5 of the ‘282:

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

Claim 5 is directed at any 15 nucleotide sequence coding for any part of BRCA1 protein.  This includes ~1.6 million sequences or about 1 in 600 of all possible 15-mers with 340,000 “infringing” 15-mers on human chromosome 1.

Wells believes that gene patents potentially inhibit development and commercialization of products and technologies that look at many genes simultaneously.

While it has to be noted that Affymetrix has a personal interest in having gene sequences free from patents — Affymetrix sells integrated GeneChip microarrays (chips) consisting of nucleic acid sequences with total revenues of $327.1 million for 2009 — it was eye-opening to know that the cost of sequencing the entire human genome is projected to be $1,000 in near future.  If you add just $100 per gene for royalties for each of the 25,000 genes, the cost would be $2,501,000!  That, of course, is if you can get all of the patentees to agree.

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solipsism – n. – the theory that the self can be aware of nothing but its own experiences.

You already know they exist — out there somewhere — waiting to bash your company.  Just look at websites such as “I Hate Boingo” and “PayPal Sucks.”  Don’t even get me started on all the variations of “Microsoft Sucks.”

Richard Telofski addresses this troubling problem in his new book, Insidious Competition: The Battle for Meaning and the Corporate Image, which outlines the battle for meaning with regard to your corporate image and explains how you can fight back in today’s online world.

How does one control a crowd? If left unchecked, a crowd can easily turn into a lynch mob, with your business as the target?  Insidious Competition is dedicated to making companies aware that this competition for their corporate images is real with harmful effects and that, unlike other traditional competitors, is just not being taken seriously.

What makes non-traditional and insidious completion “competition” is that people are competing for the image of the corporation and are doing so online, within the social web.  Please note that here Insidious Competition does not include legitimate complaints about a company.  Insidious Competition is not the considered criticism of a product or a service, which may enable the marketers of that product or service to improve their offering, that should worry management.  It’s not the balanced argument which contributes to reasonable discourse that threatens the corporate image.  No, it’s the antithesis of these, coming from within social media, that threatens the corporate image.

What are the Five Factors of Insidious Competition?

Factor Explanation
1.  Anonymity Social media doesn’t require that participants are correctly identified.
2.  Power The anonymity can lead to a corruption of ethical behavior, making users feel powerful.
3.  Contagion Power corrupts.  Social media users are susceptible to this infection.  And it spreads like a virus.
4.  Instinct Powerful-feeling individuals perform behaviors which they instinctively believe will be in support of the crowd’s collective interests.
5.  Disdain Deep-rooted dislike of institutions is amplified and perpetuated by the other four factors.

It’s the innuendo, insinuation, spin, implication, hint, overtone, undertone, aspersion, or allusion to the inferiority or wrongdoing of a company and/or its products or services falsely created within social media that supports the threat of insidious competitionInsidious because these innuendos, insinuations, spins, implications, hints, overtones, undertones, aspersions, or allusions proceed in a gradual and subtle manner to harm the corporate image, repeatedly, gradually, and incrementally, over time.  The danger and its effects are not noticed until it is too late.  What this process constitutes is a distortion of reality, or a battle for meaning.

Telofski notes that if we are to understand and attempt, at least, to manage insidious competition and to win that battle for meaning, then we must have the foundation for understanding that competition.  Insidious Competition then helps explain how to counter such attacks with suggested strategies and tactics tailored to the threat.

One such threat is the Mommy Blogger – “they’re nice, they’re everywhere and they converse with other mommies far and wide, 24/7/365 on a broad range of topics?  So, how can that be a bad thing?” Telofski details how Mommy Bloggers write with emotion and passion that connects with readers.  These emotions bring veracity wrapped around basic concepts of society.  How can we argue against mommies?  Unfortunately, their readers often select out the parts they see as most important to pass along and the conversation gets taken out of context.  Soon you experience a drift in message that gets passed along in a mutated mess of your corporate image.

Don’t wait until “YourCompanySucks.com” starts lambasting you.

About the Author

Richard Telofski is a competitive strategy analyst. Specializing in anti-corporate activism, he examines the actions of “irregular competitors” (i.e., activists and NGOs) and how those organizations impact business from within online and offline media.

Insidious Competition: The Battle for Meaning and the Corporate Image is available through Amazon.

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I’m on my way to the BIO IP Counsels Committee Conference.  The 2010 Fall IPCC Conference, in Boston, MA, is scheduled for October 18-20, 2010.  It is an opportunity for BIO members and other industry IP professionals to come together to hear, discuss and learn about current and projected topics related to biotech IP.

Program Highlights

Hear from fellow in-house colleagues, outside counsel, and PTO representatives about:

  • Evolving patent-eligibility standards for genes, biomarkers, diagnostics, and cell-based therapies;
  • Valuation of IP when selling, licensing, or acquiring biotech patent rights;
  • Present and impending changes to the way you practice before the PTO;
  • How to defend your patent in an inter partes reexam;
  • Whether inequitable conduct reform is close or elusive;
  • Inducement, divided infringement, “abstract idea” exceptions, and other things that go “bump” in the dark if you own biotech method patents;
  • Tales from the edge and beyond: accounts of biotech investment in emerging market countries.
  • Join us for private dinner reception at the New England Aquarium where attendees will get to explore a four-story ocean water tank filled with exotic fish and animals in their natural habitat.

Click here to view a conference agenda for the 2010 IPCC Fall Conference scheduled for October 18-20, 2010.

I hope to see you there!

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Frost Brown Todd has been named one of eight “standout” law firms in IP litigation in the Litigation Outlook 2011 report published by Law360 and conducted by The BTI Consulting Group.

According to BTI’s report – for which 240 corporate counsel, including 18% of the Fortune 100, were surveyed – standout firms have “made an indelible mark on clients. These firms have positioned themselves with the world’s most demanding clients as the ones corporate counsel would most like to have by their side in head-to-head competition. In essence, they are the best players in the game.”

“We believe this ranking is the result of our continuing efforts to provide superior service at a competitive cost, and to act as a partner with in-house counsel to bring innovative solutions to their most challenging problems,” said John R. Crockett III, Chairman of the Firm.

In an article published in Law360 the president of BTI Consulting, Michael Rynowecer outlined the criteria for the award when he said that “emphasis on client service, paired with some form of innovation, helped these firms rise to the top.”

The outstanding Intellectual Property Litigation Group at Frost Brown Todd includes: James Dimos, Thomas P. O’Brien III, David E. Schmit, Ann G. Schoen, Joel E. Tragesser, and a skilled group of associates, paralegals and project assistants. The IP litigation team at Frost Brown Todd is very familiar with federal courts and has handled cases all across the United States.

“We believe our IP litigation Group’s business-solution approach to IP disputes is unique,” says Ms. Schoen, Chair of the firm’s Intellectual Property Practice “We offer our clients cost-effective staffing and cost management while also providing them with some of the leading Intellectual Property lawyers in the region.

The FBT Intellectual Property group provides an uncommon advantage in patent litigation since several of its experienced patent litigators are also registered patent attorneys. Recent patent suits include those relating to processed agricultural products, business method patents in the financial services area, aluminized steel, high security locks, automobile parts, high speed sorters, elevators, consumer products and computer software, among others.

The Frost Brown Todd Intellectual Property Practice Group has been recognized as one of the top patent practices in the region (2009 and 2010 Chambers USA Business Lawyers Guide) and one of the top ten patent litigation practices in the nation by Intellectual Property Magazine. The group includes registered patent practitioners with a wide range of technical backgrounds, including a number with advanced technical degrees. Several of the group’s lawyers have been recognized in such publications as Chambers USA, Best Lawyers in America, and Super Lawyers, as top practitioners in their field.

THIS IS AN ADVERTISEMENT. ©Copyright 2010 Frost Brown Todd LLC. All rights reserved.

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The decisions of the Federal Circuit discussed in the 2010 KSR Guidelines Update provide additional examples of the law of obviousness. The purpose of the 2007 KSR Guidelines was to help Office personnel to determine when a claimed invention is not obvious, and to provide an appropriate supporting rationale when an obviousness rejection is appropriate.

The 2010 KSR Guidelines Update provides a “teaching point” for each discussed case. The “teaching point” may be used to quickly determine the relevance of the discussed case, but should not be used as a substitute for reading the remainder of the discussion of the case in this 2010 KSR Guidelines Update. Nor should any case in this 2010 KSR Guidelines Update be applied or cited in an Office action solely on the basis of what is stated in the “teaching point” for the case.

Examples + Teaching Points

In re Omeprazole Patent Litigation, 536 F.3d 1361 (Fed. Cir. 2008). Teaching point: Even where a general method that could have been applied to make the claimed product was known and within the level of skill of the ordinary artisan, the claim may nevertheless be nonobvious if the problem which had suggested use of the method had been previously unknown.

Crocs, Inc. v. U.S. International Trade Commission, 598 F.3d 1294 (Fed. Cir. 2010). Teaching point: A claimed combination of prior art elements may be nonobvious where the prior art teaches away from the claimed combination and the combination yields more than predictable results.

Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed. Cir. 2008). Teaching point: A claimed invention is likely to be obvious if it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they have been combined.

Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed Cir. 2009). Teaching point: A combination of known elements would have been prima facie obvious if an ordinarily skilled artisan would have recognized an apparent reason to combine those elements and would have known how to do so.

Wyers v. Master Lock Co., No. 2009-1412, —F.3d—, 2010 WL 2901839 (Fed. Cir. July 22, 2010). Teaching point: The scope of analogous art is to be construed broadly and includes references that are reasonably pertinent to the problem that the inventor was trying to solve. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.

DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314 (Fed. Cir. 2009). Teaching point: Predictability as discussed in KSR encompasses the expectation that prior art elements are capable of being combined, as well as the expectation that the combination would have worked for its intended purpose. An inference that a claimed combination would not have been obvious is especially strong where the prior art’s teachings undermine the very reason being proffered as to why a person of ordinary skill would have combined the known elements.

In re ICON Health Fitness, Inc., 496 F.3d 1374 (Fed. Cir. 2007). Teaching point: When determining whether a reference in a different field of endeavor may be used to support a case of obviousness (i.e., is analogous), it is necessary to consider the problem to be solved.

Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337 (Fed. Cir. 2008). Teaching point: Analogous art is not limited to references in the field of endeavor of the invention, but also includes references that would have been recognized by those of ordinary skill in the art as useful for applicant’s purpose.

Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318 (Fed. Cir. 2008). Teaching point: Because Internet and Web browser technologies had become commonplace for communicating and displaying information, it would have been obvious to adapt existing processes to incorporate them for those functions.

Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293 (Fed. Cir. 2007). Teaching point: A chemical compound would have been obvious over a mixture containing that compound as well as other compounds where it was known or the skilled artisan had reason to believe that some desirable property of the mixture was derived in whole or in part from the claimed compound, and separating the claimed compound from the mixture was routine in the art.

Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd., 533 F.3d 1353 (Fed. Cir. 2008). Teaching point: A claimed compound would not have been obvious where there was no reason to modify the closest prior art lead compound to obtain the claimed compound and the prior art taught that modifying the lead compound would destroy its advantageous property. Any known compound may serve as a lead compound when there is some reason for starting with that lead compound and modifying it to obtain the claimed compound.

Procter Gamble Co. v. Teva Pharmaceuticals USA, Inc., 566 F.3d 989 (Fed. Cir. 2009). Teaching point: It is not necessary to select a single compound as a “lead compound” in order to support an obviousness rejection. However, where there was reason to select and modify the lead compound to obtain the claimed compound, but no reasonable expectation of success, the claimed compound would not have been obvious.

Altana Pharma AG v. Teva Pharmaceuticals USA, Inc., 566 F.3d 999 (Fed. Cir. 2009). Teaching point: Obviousness of a chemical compound in view of its structural similarity to a prior art compound may be shown by identifying some line of reasoning that would have led one of ordinary skill in the art to select and modify a prior art lead compound in a particular way to produce the claimed compound. It is not necessary for the reasoning to be explicitly found in the prior art of record, nor is it necessary for the prior art to point to only a single lead compound.

In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009). Teaching point: A claimed polynucleotide would have been obvious over the known protein that it encodes where the skilled artisan would have had a reasonable expectation of success in deriving the claimed polynucleotide using standard biochemical techniques, and the skilled artisan would have had a reason to try to isolate the claimed polynucleotide. KSR applies to all technologies, rather than just the “predictable” arts.

Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007). Teaching point: A claimed compound would not have been obvious where it was not obvious to try to obtain it from a broad range of compounds, any one of which could have been selected as the lead compound for further investigation, and the prior art taught away from using a particular lead compound, and there was no predictability or reasonable expectation of success in making the particular modifications necessary to transform the lead compound into the claimed compound.

Ortho-McNeil Pharmaceutical, Inc. v. Mylan Labs, Inc., 520 F.3d 1358 (Fed. Cir. 2008). Teaching point: Where the claimed anti-convulsant drug had been discovered somewhat serendipitously in the course of research aimed at finding a new anti-diabetic drug, it would not have been obvious to try to obtain a claimed compound where the prior art did not present a finite and easily traversed number of potential starting compounds, and there was no apparent reason for selecting a particular starting compound from among a number of unpredictable alternatives.

Bayer Schering Pharma A.G. v. Barr Labs., Inc., 575 F.3d 1341 (Fed. Cir. 2009). Teaching point: A claimed compound would have been obvious where it was obvious to try to obtain it from a finite and easily traversed number of options that was narrowed down from a larger set of possibilities by the prior art, and the outcome of obtaining the claimed compound was reasonably predictable.

Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008). Teaching point: A claimed isolated stereoisomer would not have been obvious where the claimed stereoisomer exhibits unexpectedly strong therapeutic advantages over the prior art racemic mixture without the correspondingly expected toxicity, and the resulting properties of the enantiomers separated from the racemic mixture were unpredictable.

Rolls-Royce, PLC v. United Technologies Corp., 603 F.3d 1325 (Fed. Cir. 2010). Teaching point: An obvious to try rationale may be proper when the possible options for solving a problem were known and finite. However, if the possible options were not either known or finite, then an obvious to try rationale cannot be used to support a conclusion of obviousness.

Perfect Web Technologies, Inc. v. Info USA, Inc., 587 F.3d 1324, 1328-29 (Fed. Cir. 2009). Teaching point: Where there were a finite number of identified, predictable solutions and there is no evidence of unexpected results, an obvious to try inquiry may properly lead to a legal conclusion of obviousness. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.

PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007). Teaching point: Even though all evidence must be considered in an obviousness analysis, evidence of nonobviousness may be outweighed by contradictory evidence in the record or by what is in the specification. Although a reasonable expectation of success is needed to support a case of obviousness, absolute predictability is not required.

In re Sullivan, 498 F.3d 1345 (Fed. Cir. 2007). Teaching point: All evidence, including evidence rebutting a prima facie case of obviousness, must be considered when properly presented.

Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357 (Fed. Cir. 2010). Teaching point: Evidence that has been properly presented in a timely manner must be considered on the record. Evidence of commercial success is pertinent where a nexus between the success of the product and the claimed invention has been demonstrated.

Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310 (Fed. Cir. 2008). Teaching point: Evidence of secondary considerations of obviousness such as commercial success and long-felt need may be insufficient to overcome a prima facie case of obviousness if the prima facie case is strong. An argument for nonobviousness based on commercial success or long-felt need is undermined when there is a failure to link the commercial success or long-felt need to a claimed feature that distinguishes over the prior art.

The technology-specific obviousness examples previously posted on the Office’s Web site are here.

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The United States Patent and Trademark Office (USPTO) issued an update to its obviousness guidelines to be used when applying the law of obviousness under 35 U.S.C. 103. This 2010 KSR Guidelines Update highlights case law developments on obviousness under 35 U.S.C. 103 since the 2007 decision by the United States Supreme Court (Supreme Court) in KSR Int’l Co. v. Teleflex Inc. These guidelines are intended to be used by Office personnel in conjunction with the guidance in the Manual of Patent Examining Procedure when applying the law of obviousness under 35 U.S.C. 103.

Introduction.

The purpose of the 2010 KSR Guidelines Update is to remind Office personnel of the principles of obviousness explained by the Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S 398 (2007) (KSR), and to provide additional guidance in view of decisions by the United States Court of Appeals for the Federal Circuit (Federal Circuit) since KSR.

Principles of Obviousness and the Guidelines.

In response to the Supreme Court’s April 2007 decision in KSR, the Office developed guidelines for patent examiners to follow when determining obviousness of a claimed invention and published these guidelines in the Federal Register and Official Gazette. See Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103 in View of the Supreme Court Decision in KSR International Co. v. Teleflex Inc., 72 FR 57526 (Oct. 10, 2007), 1324 Off. Gaz. Pat. Office 23 (Nov. 6, 2007) (2007 KSR Guidelines). The 2007 KSR Guidelines have been incorporated in the MPEP. See MPEP § 2141 (8th ed. 2001) (Rev. 6, Sept. 2007). The purpose of the 2007 KSR Guidelines was to give Office personnel practical guidance on how to evaluate obviousness issues under 35 U.S.C. 103(a) in accordance with the Supreme Court’s instruction in KSR. The 2007 KSR Guidelines also alerted Office personnel to the importance of considering rebuttal evidence submitted by patent applicants in response to obviousness rejections.

The 2007 KSR Guidelines pointed out, as had the Supreme Court in KSR, that the factual inquiries announced in Graham v. John Deere, 383 U.S. 1, 17-18 (1966) (scope and content of the prior art; differences between the claimed invention and the prior art; level of ordinary skill in the art; and secondary indicia of nonobviousness), remain the foundation of any determination of obviousness. It remains true that “[t]he determination of obviousness is dependent on the facts of each case.”Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1089 (Fed. Cir. 2008) (citing Graham, 383 U.S. at 17-18 (1966)). As for the reasoning required to support an obviousness determination, the 2007 KSR Guidelines noted that the teaching-suggestion-motivation (TSM) test was but one possible approach. The 2007 KSR Guidelines identified six other rationales gleaned from the KSR decision as examples of appropriate lines of reasoning that could also be used.

The six other rationales identified in the 2007 KSR Guidelines are: (1) Combining prior art elements according to known methods to yield predictable results; (2) simple substitution of one known element for another to obtain predictable results; (3) use of a known technique to improve similar devices, methods, or products in the same way; (4) applying a known technique to a known device, method, or product ready for improvement to yield predictable results; (5) obvious to try—choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; and (6) known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. Any rationale employed must provide a link between the factual findings and the legal conclusion of obviousness.

The Impact of the KSR Decision.

KSR’ s renewed emphasis on the foundational principles of Graham coupled with its abrogation of the strict TSM test have clearly impacted the manner in which Office personnel and practitioners carry out the business of prosecuting patent applications with regard to issues of obviousness. However, Office personnel as well as practitioners should also recognize the significant extent to which the obviousness inquiry has remained constant in the aftermath of KSR.

In footnote 2 of the 2007 KSR Guidelines, the Office acknowledged that ongoing developments in the law of obviousness were to be expected in the wake of the KSR decision. That footnote also stated that it was “not clear which Federal Circuit decisions will retain their viability” after KSR. See 2007 KSR Guidelines, 72 FR at 57,528 n.2. The edition of the MPEP that was current when the KSR decision was handed down had made the following statement in § 2144:

The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.MPEP § 2144 (8th ed. 2001) (Rev. 5, Aug. 2006) (citing five pre-KSR Federal Circuit opinions and two decisions of the Board).

The KSR decision has reinforced those earlier decisions that validated a more flexible approach to providing reasons for obviousness. However, the Supreme Court’s pronouncement in KSR has at the same time clearly undermined the continued viability of cases such as In re Lee, 277 F.3d 1338 (Fed. Cir. 2002), insofar as Lee appears to require a strict basis in record evidence as a reason to modify the prior art.

The Supreme Court’s flexible approach to the obviousness inquiry is reflected in numerous pre-KSR decisions, as can be seen in a review of MPEP § 2144. This section provides many lines of reasoning to support a determination of obviousness based upon earlier legal precedent that had condoned the use of particular examples of what may be considered common sense or ordinary routine practice (e.g., making integral, changes in shape, making adjustable). Thus, the type of reasoning sanctioned by the opinion in KSR has long been a part of the patent examination process. See MPEP § 2144.

Although the KSR approach is flexible with regard to the line of reasoning to be applied, the 2007 KSR Guidelines and MPEP § 2143 state: “The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.” MPEP § 2143. In Ball Aerosol v. Limited Brands, 555 F.3d 984 (Fed. Cir. 2009), the Federal Circuit offered additional instruction as to the need for an explicit analysis. The Federal Circuit explained, as is consistent with the 2007 KSR Guidelines, that the Supreme Court’s requirement for an explicit analysis does not require record evidence of an explicit teaching of a motivation to combine in the prior art.

[T]he analysis that “should be made explicit” refers not to the teachings in the prior art of a motivation to combine, but to the court’s analysis * * *. Under the flexible inquiry set forth by the Supreme Court, the district court therefore erred by failing to take account of “the inferences and creative steps,” or even routine steps, that an inventor would employ and by failing to find a motivation to combine related pieces from the prior art.” Ball Aerosol, 555 F.3d at 993.

The Federal Circuit’s directive in Ball Aerosol was addressed to a lower court, but it applies to Office personnel as well. When setting forth a rejection, Office personnel are to continue to make appropriate findings of fact as explained in MPEP §§ 2141 and 2143, and must provide a reasoned explanation as to why the invention as claimed would have been obvious to a person of ordinary skill in the art at the time of the invention. This requirement for explanation remains even in situations in which Office personnel may properly rely on intangible realities such as common sense and ordinary ingenuity.

When considering obviousness, Office personnel are cautioned against treating any line of reasoning as a per se rule. MPEP § 2144 discusses supporting a rejection under 35 U.S.C. 103 by reliance on scientific theory and legal precedent. In keeping with the flexible approach and the requirement for explanation, Office personnel may invoke legal precedent as a source of supporting rationale when warranted and appropriately supported. See MPEP § 2144.04. So, for example, automating a manual activity, making portable, making separable, reversal or duplication of parts, or purifying an old product may form the basis of a rejection. However, such rationales should not be treated as per se rules, but rather must be explained and shown to apply to the facts at hand. A similar caveat applies to any obviousness analysis. Simply stating the principle (e.g.,“art recognized equivalent,” “structural similarity”) without providing an explanation of its applicability to the facts of the case at hand is generally not sufficient to establish a prima facie case of obviousness.

Many basic approaches that a practitioner may use to demonstrate nonobviousness also continue to apply in the post-KSR era. Since it is now clear that a strict TSM approach is not the only way to establish a prima facie case of obviousness, it is true that practitioners have been required to shift the emphasis of their nonobviousness arguments to a certain degree. However, familiar lines of argument still apply, including teaching away from the claimed invention by the prior art, lack of a reasonable expectation of success, and unexpected results. Indeed, they may have even taken on added importance in view of the recognition in KSR of a variety of possible rationales.

At the time the KSR decision was handed down, some observers questioned whether the principles discussed were intended by the Supreme Court to apply to all fields of inventive endeavor. Arguments were made that because the technology at issue in KSR involved the relatively well-developed and predictable field of vehicle pedal assemblies, the decision was relevant only to such fields. The Federal Circuit has soundly repudiated such a notion, stating that KSR applies across technologies:

This court also declines to cabin KSR to the “predictable arts” (as opposed to the “unpredictable art” of biotechnology). In fact, this record shows that one of skill in this advanced art would find these claimed “results” profoundly “predictable.” In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009).

Thus, Office personnel should not withdraw any rejection solely on the basis that the invention lies in a technological area ordinarily considered to be unpredictable.

The decisions of the Federal Circuit discussed in this 2010 KSR Guidelines Update provide Office personnel as well as practitioners with additional examples of the law of obviousness. The purpose of the 2007 KSR Guidelines was, as stated above, to help Office personnel to determine when a claimed invention is not obvious, and to provide an appropriate supporting rationale when an obviousness rejection is appropriate. Now that a body of case law is available to guide Office personnel and practitioners as to the boundaries between obviousness and nonobviousness, it is possible in this 2010 KSR Guidelines Update to contrast situations in which the subject matter was found to have been obvious with those in which it was determined not to have been obvious. Thus, Office personnel may use this 2010 KSR Guidelines Update in conjunction with the 2007 KSR Guidelines (incorporated into MPEP §§ 2141 and 2143) to provide a more complete view of the state of the law of obviousness.

See all of the 2010 KSR Guidelines Update here.

Members of the public are invited to provide comments on the 2010 KSR Guidelines Update. The Office is especially interested in receiving suggestions of recent decisional law in the field of obviousness that would have particular value as teaching tools.

Comments concerning the KSR Guidelines Update may be sent by electronic mail message over the Internet addressed to KSR_Guidance@uspto.gov, or submitted by mail addressed to: Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450. Although comments may be submitted by mail, the Office prefers to receive comments via the Internet.

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