Patent Docs

John Marshall Law School 55th Annual IP Law Conference

February 20, 2011

The John Marshall Law School Center for Intellectual Property Law will be holding its 55th Annual Intellectual Property Law Conference on February 25, 2011 in Chicago, IL. The conference will consist of the following sessions:

• Recent Developments in Intellectual Property Law
• The Honorable James F. Holderman, Chief Judge, U.S. District Court for the Northern District of Illinois will present a luncheon keynote on "The Future Challenges of IP Litigation: A Judge's Perspective"

The conference's afternoon patent track will consist of sessions on:

• In re Bilski and what to do about it
• Apportionment issues in IP damages cases
• False patent marking
• Patenting items derived from nature — to be presented by Patent Docs author Dr. Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP

Additional information about the conference, including a schedule, list of speakers, and registration form can be found here. Those interested in registering for the conference online can do so here; the registration fee is $195 (general rate), $95 (government, judicial, and academic rate), or free (JMLS students).
Northwestern JTIP Sixth Annual Symposium

February 18, 2011

The Northwestern Journal of Technology & Intellectual Property will be holding its Sixth Annual Symposium on March 4, 2011 on the Chicago Campus of Northwestern University. The Symposium, entitled "The Economics of Intellectual Property and Technology," will consist of the following sessions:

• Economics of Biotechnology: The Human Gene Patenting Debate — a panel discussion on the implications of the recent Myriad litigation on the future of gene patents and the development of medical treatments featuring Patent Docs author Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff; Yvonne Cripps of the University of Indiana; and Andrew Robertson of BIO Ventures for Global Health;

• Economics of Licensing and Intellectual Property Capitalization — a panel discussion examining issues such as how companies are licensing their IP, the potential regulation of IP, and the impact of non-practicing entities featuring Jay Kesan of the University of Illinois (moderator); Emily Miao of McDonnell Boehnen Hulbert & Berghoff; James Gerard Conley of the Kellogg School of Management; and Manny Schecter of IBM;

• Economics of Telecommunication: The Impact of the Broadband Plan on Competition — a panel discussion debating the current state of broadband competition, disputes between content providers and carriers, and the future of intellectual property protection and control in the developing ecosystem featuring James Speta of the Northwestern University School of Law (moderator); Thomas Hazlett of George Mason University; Daniel Spulber of the Kellogg School of Management; Kevin Martin of Patton Boggs; and Gregory Rosston of the Stanford Institute for Economic Policy Research; and

• IP & Technology Conversation — John McGinnis of the Northwestern University School of Law will discuss his research and book Accelerating Democracy and lead a discussion with Robert Bennett of the Northwestern University School of Law and Ilya Somin of George Mason University.

Additional information about the Symposium, including a schedule, list of speakers, and directions can be found at the Symposium's website. Those interested in registering for the conference can do so here (while registration for the Symposium is free, CLE credit will be available to attendees for a fee of $50 per credit hour).

The Symposium is sponsored in part by McDonnell Boehnen Hulbert & Berghoff LLP.
Clinical Biotech Forum West

February 18, 2011

The Institute for International Research (IIR) will be holding its Clinical Biotech Forum West on March 31, 2011 in Phoenix, AZ. The comprehensive one-day meeting delivers content designed for executives from small to midsize biopharmaceutical companies under 500 people looking for tools to execute fast, effective, and compliant clinical trials to achieve ROI and ensure regulatory approval.

IIR faculty will offer presentations on the following topics:

• Industry overview — The Avoca Group industry report;
• Understand the economics of running clinical trials and optimize your financial management;
• Obtaining funding — How to attract venture capitalists;
• What every biotech start-up needs to know about IP protection — to be presented by Patent Docs author Donald Zuhn;
• Explore critical considerations in selecting the right partner — Develop a vendor assessment and selection process;
• Explore the advantages and disadvantages of partnering with a large CRO vs. a specialty CRO;
• Smarter outsourcing strategies for biotechs — Best practices for managing your clinical trials;
• Constructive project management;
• Regulatory challenges and approaches for interacting with the FDA; and
• Virtual drug development models.

An agenda for the Clinical Biotech Forum West can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration information can be obtained on the conference website.

The registration fee is $795 (the conference is only open to biotech executives). Those interested in registering for the conference can do so here, by calling 1-888-670-8200, or by e-mail at register@iirusa.com.
Webinar on the European Patent System

February 18, 2011

The American Bar Association (ABA) Section of Intellectual Property Law, Young Lawyers Division, ABA-IPL Young Lawyers Action Group, Section of International Law, and the ABA Center for Continuing Legal Education will be offering a webinar and teleconference entitled "Navigating the IP Waters of Europe — Understanding and Using the European Patent System" on February 25, 2011 from 1:00 – 2:00 PM (Eastern). Brent Jacobs of Brent C. Jacobs, Esq. Attorney at Law and Gwilym Roberts of Kilburn & Strode LLP will present:

• An overview of IP protection systems in Europe;
• An understanding of the overlap and interaction between national and international systems;
• The comparative benefits of using the national vs. EP route for patents;
• The basic principles of patentability in Europe;
• Special features — added matter and inventive step;
• The processes within the EPO and leveraging the system; and
• The upcoming law changes in the patent arena in Europe.

The registration fee for the webcast is $60 for Section of Intellectual Property Law members and Section of International Law members, $100 for ABA members, and $120 for the general public (for additional fee options, please visit the event website). Those interested in registering for the webinar, can do so here or by calling 800-285-2221.
PCT and EP Filings on the Rise Again

February 17, 2011

By Donald Zuhn —

Last week, the World Intellectual Property Organization (WIPO) announced that International patent filings under the Patent Cooperation Treaty (PCT) rose from 155,398 in 2009 to 162,900 in 2010 — an increase of 4.8%. While the United States ranked first in filings with 44,855 applications, this still marked a 1.7% decline from the 45,618 applications that were filed in 2009. China saw the strongest growth in PCT filings, with applications up 56.2% to 12,337 in 2010. Japan, Germany, and South Korea rounded out the remainder of the top five with 32,156; 17,171; and 9,686 applications, respectively.

When 2010 filings were sorted into 35 technical fields by International Patent Classification (IPC), the top five fields were:

(1) Electrical machinery, apparatus, energy: 10,581 applications
(2) Medical technology: 10,465
(3) Computer technology: 9,540
(4) Electrical machinery, apparatus, energy: 9,143
(5) Pharmaceuticals: 7,843

While the fields of biotechnology and organic fine chemistry each had more than 5,000 filings (with 5,206 and 5,511, respectively), both fields saw filings drop in 2010 (down 1.5% and 2.9%, respectively). However, only six of 35 technical fields saw filings rise in 2010 (digital communication; semiconductors; materials, metallurgy; electrical machinery, apparatus, energy; thermal processes and apparatus; and medical technology).

According to WIPO's figures, the top ten corporate PCT filers in 2010 were:

(1) Panasonic Corp. (Japan) – 2,154 applications
(2) ZTE Corp. (China): 1,863
(3) Qualcomm Inc. (U.S.): 1,677
(4) Huawei Technologies Co., Ltd. (China): 1,528
(5) Koninklijke Philips Electronics N.V. (Netherlands): 1,435
(6) Robert Bosch GmbH (Germany): 1,301
(7) LG Electronics Inc. (South Korea): 1,298
(8) Sharp Kabushiki Kaisha (Japan): 1,286
(9) Telefonaktiebolaget LM Ericsson (Sweden): 1,149
(10) NEC Corp. (Japan): 1,106

and the top five university filers in 2010 were:

(1) The Regents of the University of California (U.S.): 306 applications
(2) Massachusetts Institute of Technology (U.S.): 145
(3) Board of Regents, The University of Texas System (U.S.): 130
(4) University of Florida (U.S.): 107
(5) The University of Tokyo (Japan): 105

A list of the top corporate and university filers can be found here.

In January, the European Patent Office (EPO) announced that it had also seen a rise in application filings in 2010. According to the EPO release, 232,000 European applications were filed in 2010, up 10% from the 211,000 filings in 2009. The EPO noted that 39% of the applications originated from the 38 member states of the European Patent Organisation, 26% came from the U.S., 18% were from Japan, and 5% were from each of South Korea and China. The EPO also noted that 58,100 European patents were granted in 2010, up 11% from the 52,400 patents granted in 2009. More detailed statistics are expected to be released later this year.
Biotech/Pharma Docket

February 17, 2011

By James DeGiulio —

Medicis and Q-Med Settle Restylane Dispute with Genzyme

Genzyme has agreed to drop its infringement suit with Medicis regarding the cosmetic injection product Restylane in exchange for a lump sum payment from Q-Med. In October 2010, Genzyme brought suit in the U.S. District Court for the District of Massachusetts against Medicis, who licenses the product from Q-Med (see "Court Report," October 25, 2010). Genzyme claimed that importing and selling Restylane, Perlane, Restylane-L, and Perlane-L injection products infringed U.S. Patent No. 5,399,351. Genzyme alleged that Medicis also actively induced the infringement of the patent by selling these products together with instructions that advised others to infringe the '351 patent. Q-Med, as licensor, was not named as a defendant in the suit, but Q-Med elected to assume the defense of Genzyme's claim in accordance with its license agreement with Medicis.

On February 15, Q-Med announced in a press release that the parties had reached a settlement agreement, and that Genzyme agreed to dismiss the case and release Medicis and Q-Med from any liability related to the suit. Q-Med did not disclose the exact sum paid to Genzyme. However, Medicis is not required to make any payments under the terms of the settlement and none of the parties admit any liability related to the lawsuit's claims.

Sun Agrees to Briefly Stop Selling Generic Eloxatin

As Sun Pharma and Sanofi-Aventis continue to try to close their long-running battle over the cancer drug Eloxatin, Sun has agreed to temporarily halt its sales of oxaliplatin while the parties decide how to proceed with the infringement dispute that appeared to have been settled. The case has a long history. In 2007, the dispute between Sun and Sanofi-Aventis began, after Sanofi brought suit against Sun in response to Sun's ANDA filing, alleging infringement of U.S. Patent No. 5,338,874 (see "Court Report," July 30, 2007). Sanofi also filed suit against other generic drug manufacturers who filed ANDAs for generic oxaliplatin. In 2009, the parties entered into settlement negotiations, eventually agreeing to a license. Two days after Sanofi and Sun reached a settlement agreement, the District Court denied summary judgment of invalidity and granted summary judgment of noninfringement of '874 patent. A series of challenges to the original license agreement followed, eventually reaching the Federal Circuit, which vacated the settlement and remanded the case because the disputed language in the consent judgment was susceptible to two different interpretations (see "Sanofi-Aventis v. Sandoz, Inc. (Fed. Cir. 2010)"). The Federal Circuit denied Sanofi's request for reconsideration of this decision on February 7.

On February 9, Judge Joel A. Pisano of the U.S. District Court for the District of New Jersey approved the stipulation and proposed order requiring Sun to briefly refrain from selling, attempting to sell, or offering for sale any product containing oxaliplatin until February 17. In exchange, Sanofi agreed not to seek injunctive relief against Sun or its affiliates until February 15, according to the order. The agreement was sought to facilitate further negotiation in the action. This latest agreement can be found here.

Novozymes' Biofuel Enzyme Patent Survives Danisco Invalidity Challenge

Novozymes' patent covering a modified enzyme for use in ethanol production survived an invalidity challenge in the company's patent dispute with Danisco following the denial of Danisco's motion for summary judgment ofr invalidity. In May 2010, Novozymes sued Danisco in the U.S. District Court for the Western District of Wisconsin, claiming that Danisco and its U.S. affiliates infringed U.S. Patent No. 7,713,723, covering the modified alpha-amylase enzyme (see "Court Report," May 23, 2010). Novozymes moved for a preliminary injunction in September, asking the District Court to stop Danisco and its subsidiaries from selling GC358 and the more recent GC980 enzymes. However, that bid was denied. The Court concluded that Novozymes had failed to demonstrate that it would be irreparably harmed without an injunction, and questioned whether the patent-in-suit was actually valid, criticizing its written description. Following this ruling, Danisco moved for summary judgment of invalidity of the '723 patent.

On February 4, Judge Barbara B. Crabb denied Danisco's motion for summary judgment, rejecting the argument that the patent's written description does not convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Judge Crabb ruled that Danisco had not met its burden to prove invalidity by clear and convincing evidence. However, she also stated in her opinion that lack of enablement might be a better argument for the defendants, hinting that the specification may require undue experimentation. Judge Crabb's opinion can be found here.
Curiouser and Curiouser

February 16, 2011

By Kevin E. Noonan —

The rift that has arisen between the U.S. Patent and Trademark Office and the Justice Department over the question of patent-eligibility for isolated genes seems to be continuing. Last Thursday, the Acting Solicitor General sent a letter to the Federal Circuit, requesting to opportunity to present oral argument to the Court in support of the Justice Department's amicus curiae brief in Association of Molecular Pathology v. U.S. Patent and Trademark Office (aka the Myriad case). This brief has already exposed deep divisions between the two Cabinet departments (Justice and Commerce), with the patent solicitor evidently being completely excluded from any participation in preparing the "government's" brief. Now, the specter is raised of one part of the Executive Branch arguing to the Court that the considered judgment and almost three-decade history of practice of another department of that same government has been (and continues to be) wrong in granting patents not only on isolated human genes but also on any isolated biological (or "natural") product.

The letter, from ASG Neal Katyal (at left), informs the Court that he intends to argue the "government's" position himself, and that the parties will not oppose his motion to participate. He asks the Court to accommodate his schedule, by calendaring the argument on April 4th, to permit him to participate in oral argument before the Supreme Court (on global warming) and before the 4th Circuit (on the Affordable Care Act). Despite this busy schedule, the ASG asks the Court to grant his motion to personally participate in the Myriad argument, indicating how important the administration evidently believes this issue to be.

This scenario of one part of the Executive branch arguing against another smacks of a "gang-that-couldn't-shoot-straight" administration, and if the consequences were not so significant it might pass for political theater to the enjoyment of President Obama's political opponents but without great effect on the national polity. But the "government's" position, that natural products cannot be patent-eligible, has real-world and deleterious consequences far beyond the limited scope of patent eligibility for isolated human genes (the overwhelming majority of which will be outside the reach of patent protection in a little less than ten years). The very property the government's brief argues makes isolated genomic DNA patent-ineligible — that it is a "product of nature" — applies with even greater force for all other valuable and useful "products of nature" including almost all biologic drugs. There is typically substantially less modification involved in isolating these compounds, which are in fact merely isolated (separated from other impurities) rather than chemically changed (by breaking covalent bonds that hold the DNA molecule together). Simply put, the government's position would prevent patent protection (and thus retard commercialization) of any useful compound found in plants, microorganisms, animals, etc. This rationale also applies to products of genetic engineering, because while methods, cells for producing biologic drugs, and other components of the chain of production may be patentable, the drug itself will be less patentable the more closely it mimics the "natural product." Since differences between synthetically produced biologic drugs and the compounds as they exist in nature carry the risks of differences in stability, in vivo half-life, biological activity, and immunogenicity, the "government's" position that ASG Kaytal is so anxious to argue disincentives biologic drug production, by putting drugs that are closest in stability, in vivo half-life, biological activity, and immunogenicity to the "natural product" in the most jeopardy of failing to be eligible for patent protection. Estimates (even the "government's" estimates from the Federal Trade Commission) of the investment costs for bringing a biological drug to market are in the $1 billion range. It is unlikely that such an investment will be made in the uncertain environment that would result from the Court adopting the "government's" views on patent eligibility for such "natural products."

Looking on the bright side, the possibility exists that, under the kind of piercing questioning that ASG Kaytal is likely to face from whatever Federal Circuit panel hears this argument, he will begin to have a glimmer of an understanding on how completely the "government" has botched the opportunity to benefit from the experience of senior PTO officials and experienced legal staff, and that merely being the latest installment of the "best and brightest" isn't always enough. In instances such as these, involving questions having such real-world consequences, operating from "first principles" and attempting to impose a political solution that satisfies as many of your supporters' constituencies as possible is almost certain to involve unexpected and unintended consequences. Regardless of whether ASG Kaytal experiences his own personal epiphany on these matters, it is also possible that the Supreme Court will come to appreciate the deficiencies in the "government's" arguments, and that this will make it less likely to grant certiorari on the question of patent eligibility for isolated genes should the Federal Circuit reverse the District Court on the merits. That would be an outcome deserving of the political theater the ASG's day before the Federal Circuit is certain to become.

Patent Docs thanks Hal Wegner for alerting us to and providing a copy of ASG Kaytal's letter.

For information regarding this and other related topics, please see:

• "AMP v. USPTO — Briefing Update III," February 8, 2011
• "Amicus Briefs in AMP v. USPTO: AARP," January 27, 2011
• "AMP v. USPTO: Appellees' Brief," January 12, 2011
• "AMP v. USPTO — Briefing Update II," December 16, 2010
• "Amicus Briefs in AMP v. USPTO: Alynylam Pharmaceuticals, Inc.," December 15, 2010
• "The Relevance of Patent Exhaustion in the Myriad Genetics Case," December 14, 2010
• "AMP v. USPTO — Briefing Update," December 14, 2010
• "Amicus Briefs in AMP v. USPTO: University of New Hampshire School of Law," December 12, 2010
• "Amicus Briefs in AMP v. USPTO: Rosetta Genomics & George Mason University," December 8, 2010
• "Academic Amici Refute ACLU Falsehoods in Gene Patenting Debate," December 7, 2010
• "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
• "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
• "AIPLA Submits Amicus Brief in AMP v. USPTO," November 3, 2010
• "IPO Files Amicus Brief in AMP v. USPTO," November 2, 2010
• "AMP v. USPTO — Briefing Update," November 1, 2010
• "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
• "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010
• "AMP v. USPTO — Briefing Schedule Update," August 22, 2010
• "FCBA Submits Amicus Brief on Motion for Recusal in AMP v. USPTO," August 9, 2010
• "Appellees Move for Recusal of Chief Judge Rader in AMP v. USPTO Appeal," July 19, 2010
• "AMP v. USPTO after Bilski v. Kappos," July 6, 2010
• "Myriad Appeals AMP v. USPTO Decision," June 16, 2010
• "AMP v. USPTO: What Everyone Else Is Saying – Part II," June 8, 2010
• "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
• "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story," April 5, 2010
• "'60 Minutes' Examines Gene Patenting Issue on Sunday, April 4th — Patent Docs Author Kevin Noonan to Appear on Program," April 2, 2010
• "AMP v. USPTO: What the Parties Are Saying About the Decision," April 1, 2010
• "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims," March 30, 2010
• "Round One Goes to the ACLU," March 29, 2010
• "USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010
USPTO Promulgates Guidelines for Applying 35 U.S.C. § 112, 2nd Paragraph

February 15, 2011

By Kevin E. Noonan —

Last Wednesday, the U.S. Patent and Trademark Office promulgated "Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues" (76 Fed. Reg. 7162). The Guidelines, which take effect immediately and apply to all pending applications, "are intended to assist United States Patent and Trademark Office (Office) personnel in the examination of claims in patent applications for compliance with 35 U.S.C. 112, second paragraph" as well as assist Office personnel in examining claims containing "functional language" ("means plus function" claims under 35 U.S.C. 112, 6th para.), "especially computer-implemented invention claims," and for compliance with 35 U.S.C. 112, 4th para. ("Subject to the following paragraph, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.")

The Guidelines contain generic reference to "optimizing patent quality" and "fostering innovation and competitiveness" as some of the reasons that the Office must issue patents "with clean and definite claim language" under the statute.   Functionally, this requires Office personnel to give claim terms their "broadest reasonable interpretation" during examination, since the applicant has the opportunity to amend the claims or present arguments why claim terminology is definite (MPEP 2211). The Guidelines follow the rubrics of claim construction set forth by the Federal Circuit, inter alia, in Phillips v. AWH Corp, 415 F.3d 1303 (Fed. Cir. 2005) (en banc), having a hierarchy starting with the plain meaning of the claim terms, express definitions in the specification, and arguments made by the applicant during prosecution. "Plain meaning" is defined as the "ordinary and customary meaning" of the term. The Guidelines repeat the conventional rationale that claims under examination are not entitled to a presumption of validity, and are not to be construed to be valid. Examination in the Office uses the broadest reasonable interpretation standard in order to "establish a clear record of what [the] applicant intends to claim." The standard for deciding that a claim term is indefinite is that the metes and bounds of the claim are clear under the broadest reasonable interpretation of its terms, which is defined as whether a person of ordinary skill could read the term to have more than one reasonable interpretation. If not, the claims "must be rejected."   However, the Guidelines caution that merely because a claim term is broad it may not be indefinite "provided [that] the scope is clearly defined." The Guidelines also direct that claims should be examined to determine whether they invoke the "means plus function" format of 35 U.S.C. 112, 6th para.

The Guidelines set forth examples of claim terms that may be indefinite. These include:

1. Indeterminate terms, defined as functional claiming (that "recites a feature 'by what it does rather than by what it is'"). The Guidelines do not consider claims using functional language to be per se indefinite, but may be so when the claim "fails to provide a clear-cut indication of the scope of the subject matter" of the claim. Examples of such indefinite claims include so called "single means" claims, where "all means and methods for resolving the problem [addressed by the claim] may be encompassed by the claim." The Guidelines acknowledge that whether functional claim language is indefinite will depend on "context," i.e. whether the specification provides proper 35 U.S.C. 112, 1st para. support for the term. Examples of indefinite functional language include Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244 (Fed. Cir. 2008) and General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364 (1938), while instances of functional language that was found to satisfy the definiteness requirement include In re Marosi, 710 F.2d 799, 803 (Fed. Cir. 1983) and In re Swinehart, 439 F.2d 210, 212 (CCPA 1971).   Examination should be performed as follows:

Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) Whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.

However, "[t]he primary inquiry is whether the language leaves room for ambiguity or whether the boundaries are clear and precise."

2. Terms of degree. The examination standard stated in the Guidelines is whether the specification provides some standard for measuring that degree," citing Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357, 1367 (Fed. Cir. 2010); Enzo Biochem, Inc., v. Applera Corp., 599 F.3d 1325, 1332 (Fed. Cir. 2010); Seattle Box Co., Inc. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 826 (Fed. Cir. 1984). If not, the question becomes whether the ordinarily skilled worker would be able to ascertain the scope. Satisfaction of either of these prongs of the inquiry renders the claim definite.   Declaration evidence (pursuant to 37 C.F.R. 1.132) can also be used to support definiteness by providing examples.

3. Subjective terms are treated similarly to terms of degree, depending for definiteness on whether the specification provides "some standard for measuring the scope of the term," or whether the skilled worker would be able to ascertain the scope. However, "[a] claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. . . . Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention." The Guidelines cite the Datamize case as an example. Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342 (Fed. Cir. 2005).

4. Markush language. The Guidelines purport to apply the indefinite rubrics to "any claim that recites a list of alternative useable species regardless of format." The size of the Markush group (i.e., the number of species) is not determinative but can be under conditions where the group is "so expansive that persons skilled in the art cannot determine the mete and bounds of the claimed invention (i.e., cannot envision all of the members of the group). Also indefinite are "improper" Markush claims, that encompass species that do not share a "single structural similarity" (defined as belonging to the same recognized chemical or physical (or art-recognized) class) or do not share a common use.

Included in this portion of the Guidelines are rules for determining whether a dependent claim complies with 35 U.S.C. 112, 4th para.; rejection is mandated rather than objecting to the claim as a matter of form.

Having reviewed examination, the Guidelines next discuss how compliance with 35 U.S.C. 112, 2nd para. should be integrated into assessing whether the specification complies with 35 U.S.C. 112, 1st para.    The Guidelines do not mandate but do encourage the use of "glossaries" of terms in the specification as being "a helpful device for ensuring adequate definition of terms used in the claims." Examiners are also instructed to determine whether claims that are definite on their face are indefinite due to inconsistencies between how terms are used in the claims and in the specification, citing In re Cohn, 438 F.2d 989, 993 (CCPA 1971); In re Moore, 439 F.2d 1232, 1235-36 (CCPA 1971); and In re Anderson, 1997 U.S. App. Lexis 167 (Fed. Cir. Jan. 6, 1997) (unpublished) as examples.

The portion of the Guidelines relating to 35 U.S.C. 112, 6th para. recite conventional rules regarding whether an applicant has invoked this claim format, relating to instances where "means for" and "step for" are used to so invoke the 6th para. structure and instances where the form is applied even though these terms are not used (and the presumptions that attach to each).   The Guidelines set forth numerous examples of "non-structural terms" that invoke the format (including “mechanism for,'' “module for,'' “device for,'' “unit for,'' “component for,'' “element for,'' “member for,'' “apparatus for,'' “machine for,'' or “system for") and ones that have been found to not invoke the format (including “circuit for,'' “detent mechanism,'' “digital detector for,'' “reciprocating member,'' “connector assembly,'' “perforation,'' “sealingly connected joints,'' and “eyeglass hanger member.''). Indications that the format is intended can also be discerned from the specification, dictionary definitions and the art. The Guidelines also provide a modification to the 3-pronged analysis set forth in MPEP 2181:

Examiners will apply Sec. 112, 6th para. to a claim limitation that meets the following conditions: (1) The claim limitation uses the phrase “means for'' or “step for'' or a non-structural term that does not have a structural modifier; (2) the phrase “means for'' or “step for'' or the non-structural term recited in the claim is modified by functional language; and (3) the phrase “means for'' or “step for'' or the non-structural term recited in the claim is not modified by sufficient structure, material, or acts for achieving the specified function.

The application of the Guidelines to claims using the 112, 6th para. format requires that "the written description must clearly link or associate the corresponding structure, material, or acts to the claimed function . . . A bare statement that known techniques or methods can be used would not be a sufficient disclosure to support a means-plus-function limitation."

The Guidelines specifically address "computer-implemented means-plus-function limitations," requiring that the corresponding structure is required to be more than simply a general purpose computer or microprocessor," citing Aristocrat Techs. Australia Pty Ltd. v. Int'l Game Tech., 521 F.3d 1328, 1333 (Fed. Cir. 2008). The Guidelines state that disclosing only a general purpose computer as the structure to perform the function "amounts to pure functional claiming. Instead, the Guidelines require that the computer-implemented function "must" include the algorithm that transforms the general purpose computer into a "special purpose computer." Generic recitations of "software" that do not provide sufficient details to provide the algorithm are insufficient. The Guidelines expressly reject the proposition that disclosure of the algorithm is unnecessary if the skilled worker "is capable of writing the software," citing Blackboard, Inc. v. Desire2Learn, Inc., 574 F.3d 1371, 1383-1385 (Fed. Cir. 2009) and Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1366-67 (Fed. Cir. 2008).

Turning to how Examiners should handle indefinite claim language, the Guidelines require that the Examiner "establish a clear record" ("a complete and accurate picture of the Office's consideration of the patentability of an application"), referring to MPEP 2173.05 to provide "numerous examples of rationales that may support" a 112, 2nd para. rejection.   This record includes the Office Action, which should provide the applicant with a "sufficient explanation" of the grounds of rejection for the Applicant to be able to provide "a meaningful response," by then Examiner "pointing out the specific term or phrase that is indefinite" and why the Examiner considers it to be so. However, while the Examiner properly can provide suggestions on how to amend the claim to overcome the rejection, the Guidelines state that rejection under 35 U.S.C. 112, 2nd para. should not be made "merely . . . to improve the clarity or precision of the language used;" a claim objection is the more appropriate way to achieve this goal. The Guidelines also require that the Examiner "practice compact prosecution" by "clearly articulat[ing] any rejection early in the prosecution process so that the applicant has the chance to provide evidence of patentability and otherwise reply completely at the earliest opportunity." If indefiniteness is the only issue, the Guidelines instruct examiners to "open lines of communication with the applicant" by suggesting ways to overcome the rejection through interviews. If an applicant overcomes an indefiniteness rejection, the Guidelines encourage the Examiner to put on the record the reasons for allowance, including the steps taken that overcame this rejection pursuant to 37 C.F.R. 1.104(e).

Finally, the Guidelines contain a brief synopsis of patentability requirements for computer-implemented inventions than encompasses all the statutory requirements.

Public comments are solicited, to be received on or before April 11, 2011; comments should be submitted by e-mail to SEGuidelines112@uspto.gov.   Promulgation of these Guidelines does not constitute substantive rulemaking by the Office, and thus do not require a public hearing under the Administrative Procedures Act (there will be no public hearing). In addition, the Notice asserts that public notice and comment are not required, and that the Office merely solicits comments for their own benefit. Also, failure of the Office to comply with these Guidelines is neither appealable nor petitionable.
USPTO and EPO Agree to Principles of Joint Patent Classification System

February 14, 2011

By Donald Zuhn —

On February 4, the U.S. Patent and Trademark Office and European Patent Office announced that the two offices had reached agreement on the principles of a new joint patent classification system known as the Cooperative Patent Classification (CPC). The desire to develop a joint classification system was first announced last fall (see "USPTO and EPO to Develop Joint Patent Classification System").

The agreement on the CFC, which will be co-managed by the USPTO and EPO, was reached following meetings at the USPTO from November 29 to December 1, 2010, and at the EPO from January 24-26, 2011. The joint classification system is based on the International Patent Classification (IPC) system, which is administered by the World Intellectual Property Organization (WIPO), and will use the European Classification system (ECLA) as a foundation onto which the best aspects of the USPTO classification system will be incorporated.
Court Report

February 13, 2011

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Novartis Pharmaceuticals Corp. et al. v. Mylan Pharmaceuticals Inc. et al.
1:11-cv-00127; filed February 10, 2011 in the District Court of Delaware

• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.

Infringement of U.S. Patent No. 6,242,003 ("Organic Compounds," issued June 5, 2001) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Lescol® (fluvastatin sodium, used to treat hypercholesterolemia). View the complaint here.

Astrazeneca AB et al. v. Hanmi USA, Inc. et al.
3:11-cv-00760; filed February 9, 2011 in the District Court of New Jersey

• Plaintiffs: Astrazeneca AB; Aktiebolaget Hassle; Astrazeneca LP; KBI INC.; KBI-E INC.
• Defendants: Hanmi USA, Inc.; Hanmi Pharmaceutical Co., Ltd.; Hanmi Fine Chemical Co., Ltd; Hanmi Holdings Co., Ltd.

Infringement of U.S. Patent Nos. 5,714,504 ("Compositions," issued February 3, 1988) and 5,877,192 ("Method for the Treatment of Gastric Acid-Related Diseases and Production of Medication Using (-)Enantiomer of Omeprazole," issued March 2, 1999 following a Paragraph IV certification as part of Hanmi's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a modified generic version (esomeprazole strontium) of AstraZeneca's Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease). View the complaint here.

Jazz Pharmaceuticals, Inc. v. Roxane Laboratories, Inc.
2:11-cv-00660; filed February 4, 2011 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,472,431 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued October 29, 2002) and 7,851,506 (same title, issued December 14, 2010) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.

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