•     By Donald Zuhn

    Uspto_seal_no_background
    On August 21, 2007, the U.S. Patent and Trademark Office published new
    rules concerning continuation and claims practice that will undoubtedly
    have a profound effect on the way patent attorneys and agents prosecute
    applications before the Patent Office.  In view of the 128-page Federal Register notice
    regarding the new rules, the Patent Office’s nearly two hour webcast on
    August 23, 2007 (and the webcast’s accompanying 109-page presentation), and the Office’s 45-page list of Frequently Asked Questions, Patent Docs
    believes it may be helpful to examine the rules piece-by-piece in an
    attempt to identify areas where patent attorneys and agents will need
    to modify their patent prosecution practice.


    37 C.F.R. § 1.78(d)(1)(i) & (vi):

    A Patent Docs reader recently asked whether a Demand filed with the International Preliminary Examining Authority, requesting an international preliminary examination, would constitute a member of an application family.  In other words, the reader wanted to know whether the Demand would cut into the three-application limit imposed by the new rules – i.e., whether the Demand would, in effect, constitute the parent application in an application family, with the national stage application constituting the first continuation permitted under the new rules, and a continuation filed off the national stage application constituting the second, and final, continuation permitted under the new rules (absent a petition and showing).

    Federal_register_cover
    This is an important question, since many biotech and pharma patent practitioners have probably begun considering the benefits of filing an international application instead of a U.S. nonprovisional application under the new rules.  One significant benefit of such a strategy is the up to 18 months of additional time for plotting a prosecution strategy that an applicant can obtain by filing an international application and then waiting until the last possible moment to enter national stage in the U.S.

    The short answer to the reader’s question is that the Demand does not constitute a member of the application family under the new rules.  And now for the long(er) answer.

    In normal PCT practice, an applicant usually files a provisional or foreign application, files an international application claiming the benefit of the provisional, and then files a national stage application.  Under such circumstances, Rule 78(d)(1)(i) applies, and an applicant is permitted to file two more continuations that claim the benefit of the national stage application.

    In particular, Rule 78(d)(1)(i)(A) states that a continuation or continuation-in-part application can "claim[] the benefit under 35 U.S.C. 120, 121, or 365(c) of no more than two-prior filed applications."  Thus, the second continuation would claim the benefit of the first continuation and the national stage application (and the national stage application would be entitled to the benefit of its international filing date and prior filed provisional/foreign application under the PCT).

    In addition, Rule 78(d)(1)(i)(B) states that any application whose benefit is claimed under 78(d)(1)(i)(A) can only be claimed by one other application.  Thus, the national stage application would be claimed by the first continuation and second continuation.  For the purposes of Rule 78(d)(1)(i), neither the national stage application nor the first and second continuations would be claiming the benefit of the international application.  In other words, all of these applications get the benefit of the international filing date and the provisional/foreign filing date through the national stage application, and the national stage application is effectively the parent application in the application family.

    The above situation can be illustrated like this:

    provisional/foreign application —> international application –> national stage application –> continuation 1 –> continuation 2

    As an alternative to the above scenario, an applicant can decide to file a "bypass continuation" instead.  Rule 78(d)(1)(iv) applies to bypass continuations.  A bypass continuation is a U.S. application that claims the benefit of an international application where the Demand has not been made and the national filing fee has not been paid.  This situation can be illustrated like this:

    provisional/foreign application –> international application –> bypass continuation –> continuation 2 –> continuation 3

    If Rule 78(d)(1)(iv) did not exist, Rule 78(d)(1)(i) would prohibit an applicant from filing continuation 3 above because it would have to claim the benefit of the international application, the bypass continuation, and continuation 2 (and thus would claim the benefit of three applications).  In particular, continuation 3 would need to claim the benefit of the international application under 35 U.S.C. §§ 120 and 363.

    In order to prevent applicants from trying to prosecute a bypass continuation and national stage application in parallel, Rule 78(d)(1)(iv)(A) forces an applicant to choose to prosecute the application family through the bypass continuation or the national stage application, and not do both (i.e., an applicant cannot file a national stage application without filing a Demand and paying the national filing fee, and an applicant cannot choose to go the (d)(1)(iv) route if the Demand has been filed and national filing fee has been paid).

    In summary, a bypass continuation is U.S. application that claims the benefit of an international application under 35 U.S.C. §§ 120 and 363 and a national stage application is a U.S. application that claims the benefit of an international application under 35 U.S.C. § 365(c).  Thus, each is a distinct type of application, and each gets the benefit of the international application – albeit in different ways.

    In addition, the number of continuations an applicant can obtain (without filing a petition and showing) turns on whether the applicant files a Demand and pays the national filing fee.  There are three scenarios:

    1.  If an applicant files a national stage application, the national stage application is the parent application in the application family, and the applicant can file two continuations under Rule 78(d)(1)(i).

    2.  If an applicant files a bypass continuation claiming the benefit of an international application on which no Demand was made and no national filing fee was paid, the international application is the parent application in the application family, and the applicant can file three continuations under Rule 78(d)(1)(iv): the bypass continuation being the first of the three continuations.

    3.  If an applicant files a bypass continuation claiming the benefit of an international application on which a Demand was made and the national filing fee was paid, the international application is the parent application in the application family, and the applicant can file two continuations under Rule 78(d)(1)(i).  The two continuations would be the bypass continuation and the next continuation filed.

    For additional articles in this series, please see:

    For additional information on this and other related topics, please see:


    Changes to Rule 78(d)(1)(vi):

    (d) Claims under 35 U.S.C. 120, 121, or 365(c) for the benefit of a prior-filed nonprovisional or international application. A nonprovisional application (including an international application that has entered the national stage after compliance with 35 U.S.C. 371) may claim the benefit of one or more prior-filed copending nonprovisional applications or international applications designating the United States of America under the conditions set forth in 35 U.S.C. 120 and paragraph (d) of this section.

    (1) A nonprovisional application that claims the benefit of one or more prior filed copending nonprovisional applications or international applications designating the United States of America must satisfy the conditions set forth in at least one of paragraphs (d)(1)(i) through (d)(1)(vi) of this section. The Office will refuse to enter, or will delete if present, any specific reference to a prior-filed application that is not permitted by at least one of paragraphs (d)(1)(i) through (d)(1)(vi) of this section. The Office’s entry of, or failure to delete, a specific reference to a prior-filed application that is not permitted by at least one of paragraphs (d)(1)(i) through (d)(1)(vi) of this section does not constitute a waiver of the provisions of paragraph (d)(1) of this section.

    (i)(A) The nonprovisional application is either a continuation application as defined in paragraph (a)(3) of this section or a continuation-in-part application as defined in paragraph (a)(4) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of no more than two prior-filed applications; and
    (B) Any application whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such nonprovisional application has its benefit claimed in no more than one other nonprovisional application, not including any nonprovisional application that satisfies the conditions set forth in paragraph (d)(1)(ii), (d)(1)(iii) or (d)(1)(vi) of this section.

    * * *

    (iv)(A) The nonprovisional application claims benefit under 35 U.S.C. 120 or 365(c) of a prior-filed international application designating the United States of America, and a Demand has not been filed and the basic national fee (§ 1.492(a)) has not been paid in the prior-filed international application and the prior-filed international application does not claim the benefit of any other nonprovisional application or international application designating the United States of America;
    (B) The nonprovisional application is either a continuation application as defined in paragraph (a)(3) of this section or a continuation-in-part application as defined in paragraph (a)(4) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of no more than three prior-filed applications; and
    (C) Any application whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such nonprovisional application has its benefit claimed in no more than two other nonprovisional applications, not including any nonprovisional application that satisfies the conditions set forth in paragraph (d)(1)(ii), (d)(1)(iii) or (d)(1)(vi) of this section.

  • Calendar_13
    September 24-25, 2007 – Biosimilars 2007 (Scherago International, Inc.) – George Washington University, Washington, D.C.

    September 26-27, 2007 – Advanced Forum on Biotech Patents (American Conference Institute) – Boston, MA***

    September 27-28, 2007 – Biotechnology: Business and Legal Developments (Law Seminars International) – Seattle, WA

    October 10-12, 2007 – Stem Cells European Business Summit – Edinburgh, Scotland

    October 12, 2007 – Intellectual Property Law Summit 2007 (West LEGALWorks and Intellectual Property Law Association of Chicago) – Chicago, IL

    October 16, 2007 – New Patent Rules Update: Implications of Compliance (World Research Group)

    October 25-26, 2007 – Biotech and Pharma Public-Private Partnerships Forum (American Conference Institute) – Washington, D.C.***

    October 25-27, 2007 – Biotechnology: Patent Prosecution, Licensing, Litigation & Hatch-Waxman (Patent Resources Group) – Palm Springs, CA

    November 13-15, 2007 – Pharma and Biotech Collaborative Agreements (American Conference Institute) – New York, NY***

    ***Patent Docs is a media sponsor of this conference or CLE.

  •     By Jason Derry —

    Exelixis_logo_2
    Exelixis and Bristol-Myers Squibb have announced an agreement to extend their research collaboration relating to cardiovascular and metabolic diseases for an additional year, now ending in January 2009.  Under the terms of the extension, Exelixis will receive an additional $7.5 million in funding.  The collaboration is focused on developing therapies against the Liver X Receptor (LXR).  The companies hope to discover and develop drug candidates that will activate LXR, which may cause removal of cholesterol from the body and also suppression of inflammatory responses associated with atherosclerosis.

    Bristolmyers_squibb_1

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  • World Research Group World Research Group (WRG) will be offering a webinar entitled: "New Patent Rules Update: Implications of Compliance" on October 16, 2007 from 12:00-1:30 PM (EST).  Speakers Charles R. Macedo and Marlon P. Metelski of Amster, Rothstein and Ebenstein LLP will explain the new rule changes and their implications for patent practice.

    The registration fee for this webinar is $299.  Those interested in registering for the webinar, can do so here.

  •     By Sherri Oslick

    300pxcelera_genomics_logo
    On Thursday, Celera of Rockville, MD and Alameda, CA, an Applera Corporation business, announced that it would acquire Atria Genetics, Inc. of San Fransisco, CA for approximately $33 million cash.  Atria Genetics is a private company that has developed a line of human leukocyte antigen (HLA) testing products that are used for identifying potential donors in the matching process for bone marrow transplantation.  The acquisition is expected to be completed during the second quarter of Celera’s fiscal 2008.  Abbott Molecular, a division of Abbott Laboratories, markets and distributes Atria Genetics’ current HLA sequencing-based typing products through its alliance with Celera.

    For additional information regarding the acquisition, please see:

  •     By Donald Zuhn

    Codagenomics
    Earlier this month, CODA Genomics, Inc. announced that it had been granted U.S. Patent No. 7,262,031.  CODA Genomics, Inc., which derives its name from its Computational Optimized DNA Assembly technology, has exclusively licensed the ‘031 patent from the University of California, Irvine (UCI) Office of Technology Assessment (OTA).  The founders of the Laguna Hills, California-based biotech company, Dr. Richard H. Lathrop (left) and Dr. G. Wesley Hatfield (right), are professors at UCI and named inventors on the ‘031 patent.

    Coda_genomics_2
    According to the statement released by CODA Genomics, the ‘031 patent relates to the use of a global optimization method for the choice of DNA code to make a given protein, wherein properly chosen DNA enables thermodynamically controlled self-assembly of a desired DNA product.  CODA CEO Dr. Robert J Molinari noted that the ‘031 patent provided "broad protection of CODA’s breakthrough technology" which "will allow the company to aggressively market its high-yielding Hot-Rod genes, and other optimized gene variant sets."  According to CODA’s website, the company’s Hot Rod genes are designed to express high levels of protein by removing major pauses in the gene’s open reading frame (ORF) and by improving tRNA codon usage.

    Fig1a

    The ‘031 patent issued from U.S. Application No. 10/851,383, filed May 21, 2004, and claims the benefit of U.S. Provisional Application No. 60/472,822, filed May 22, 2003.  Independent claims 1 and 42 of the ‘031 patent recites:

    1.  A method of synthesizing a DNA sequence encoding a polypeptide, comprising:
        (i) dividing the DNA sequence recursively into small pieces of DNA, wherein adjacent pieces comprise overlapping regions, wherein the division results in at least 3 pieces of DNA;
        (ii) optimizing the sequences of the pieces of DNA resulting from each recursive division in silico by silent codon permutation to strengthen correct hybridizations between adjacent pieces of DNA and to disrupt incorrect hybridizations between all other pieces of DNA resulting from that division;
        (iii) obtaining the optimized small pieces of DNA, wherein the overlapping regions of any adjacent pieces of single-stranded DNA are complementary;
        (iv) combining the pieces of DNA derived from the division of the next-larger piece of DNA;
        (v) allowing the pieces of DNA to self-assemble to form a DNA construct comprising single-stranded DNA segments connected by double-stranded overlap regions;
        (vi) producing the next-larger piece of DNA from the DNA construct; and
        (vii) repeating steps (iv), (v), and (vi) in reverse order of the recursive division in step (i) to produce the DNA sequence.

    42.  A method for identifying a set of smaller DNAs suitable for assembly into a larger DNA, where the larger DNA encodes a desired polypeptide, comprising:
        optimizing in silico a set of at least 6 smaller DNAs for assembly together to create the larger DNA, wherein adjacent smaller DNAs comprise overlapping regions, wherein the optimizing comprises permuting silent codons to strengthen correct hybridizations between adjacent pieces of the smaller DNAs and to disrupt all incorrect hybridizations between members of the set, to create a gap between melting temperatures of the lowest melting correct hybridization and the highest melting incorrect hybridization.

  • Daiichi Sankyo Co. v. Apotex, Inc. (Fed. Cir. 2007) (reissued as precedential)

        By Robert Dailey

    Much of patent law depends on the attributes of the hypothetical "person having ordinary skill in the art" (PHOSITA).  Particularly, claim construction and obviousness determinations depend on how the court defines PHOSITA for the patent-in-suit.

    Nevertheless, Federal Circuit case law provides little guidance.  The 1983 Orthopedic Equipment case articulates six non-exclusive factors that courts may use in determining the characteristics of PHOSITA: (1) education level of the inventor; (2) problems encountered in the art; (3) prior art solutions to the problem; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) education level of active workers in the field.  But subsequent case law has added little nuance to this assessment rubric.

    Daiichi_sankyo
    An earlier posting on Patent Docs summarizes the holding of the original non-precedential Daiichi Sanko case, issued this July.  Now that the CAFC has reissued the identical opinion as precedential, it’s probably worth considering what the implications might be.

    220pxofloxacinsvg
    The case involved ofloxacin (at left), a topical antibiotic used for treating ear infections.  Although many antibiotics can cause damage to the ear when applied topically, specialists in the field knew that ciprofloxacin (below) showed no such damage.  Since ofloxacin and ciprofloxacin are antibiotics having similar molecular structures, those aware of ciprofloxacin’s success would have possessed the requisite motivation to use ofloxacin in similar ways.

    220pxciprofloxazinsvg
    But the District Court had included pediatricians and general practice physicians within the class of those having ordinary skill in the art.  Since these non-specialist medical practitioners rarely, if ever, use ciprofloxacin to treat ear infections, the court ruled that ofloxacin’s success would not be obvious to PHOSITA.  The Federal Circuit reversed, holding that the District Court should have limited PHOSITA to otologists and persons who develop pharmaceutical formulations.  Since this narrower class of experts would have been aware of ciprofloxacin’s success, the use of ofloxacin to treat the same ailment is obvious.

    In this instance, the CAFC probably reached the best result.  After all, PHOSITA’s art field is determined by the nature of the invention.  Non-specialist physicians are not generally in the business of developing and testing new pharmaceutical products.  If we include them within the class of skilled artisans, then almost no pharmaceutical invention would be obvious.  Thus, this case illustrates the dangers of setting the level of ordinary skill too low.

    On the other hand, the law bids us look to the person of ordinary skill in the art.  By focusing too much on the skill set of the inventor, we run the risk of defining PHOSITA as a kind of super-skilled artisan.  In fact, PHOSITA is even less bright than the average artisan; otherwise, half of the practitioners in the art field would fall below the standard.  In other words, he’s like the B- student who barely met the minimum qualifications for graduation.

    As the CAFC points out, persons included as PHOSITA should at least be capable of carrying out the experiments necessary to create and test the invention.  But if we adorn PHOSITA with too many attributes (i.e., give him the same skills as the inventor), then we create someone for whom everything is obvious.

  •     By Christopher P. Singer

    Wipo
    In the Federal Register published Monday, September 10, 2007 (available here), the U.S. Patent and Trademark Office published its Final rules regarding certain changes the Office made in order to conform with changes introduced in the April 1, 2007 Revisions to the Patent Cooperation Treaty Procedures.  As previously reported on Patent Docs, the PCT Assembly of the World Intellectual Property Organization (WIPO) amended portions of its Regulations which took effect on April 1, 2007.  The USPTO implemented interim procedures to authorize certain portions of these changes until the Final Rules could be enacted.  Importantly, the Final Rules provide: (a) a way for an applicant to request that the right to claim priority be restored in applications that meet specific requirements; (b) a way to insert a missing portion of an international application without losing the international filing date; (c) a clarification about the circumstances in which an obvious error in an international application can be corrected; and (d) revising the search fee for international applications.

    Uspto_seal_2
    September 10, 2007 is the effective date for the changes to 37 C.F.R. §§ 1.57 (incorporation by reference), 1.437 (drawings), and 1.465 (application processing based on corrected/added/withdrawn priority date), while November 9, 2007 is the effective date for the changes to 37 C.F.R. §§ 1.17 (fee for unintentionally delayed priority claim, $1,370) and 1.445 (search fee, $1,800; and supplemental search fee, per additional invention, $1,800), as well as the addition of 37 C.F.R. § 1.452 (restoration of right of priority).

    Anyone with questions regarding the notice and these procedures is directed to contact Mr. Richard R. Cole, Senior Legal Examiner with the Office of PCT Legal Administration by telephone (571.272.3281) or fax (571.273.0459).

  •     By Donald Zuhn

    Biotechnology_industry_organization
    Earlier today, Patent Docs participated in a conference call with Jim Greenwood, the President and CEO of the Biotechnology Industry Organization (BIO).  Mr. Greenwood, who represented Pennsylvania’s Eighth District in the U.S. House of Representatives from January 1993 through January 2005 prior to his BIO appointment, had invited a handful of biotech and pharma bloggers to participate in the conference call, where he provided a briefing on the Biologics Price Competition and Innovation Act of 2007 (see "Senate Committee Passes Biologics Legislation"), which the Senate Committee on Health, Education, Labor & Pensions passed on June 27, 2007, and the Patent Reform Act of 2007 (see "Patent "Reform" Bill Passes House of Representatives"), which the House of Representatives passed on September 7, 2007.

    Greenwood_jim
    On the issue of patent reform, Mr. Greenwood (at left) stated that the House bill was "largely inspired" by the information technology industry, which relies on a business model that is quite different from that of the biotech/pharma sector.  Mr. Greenwood predicted that if the House bill were passed into law, it would be "easier and less costly to infringe patents."  While noting that the bill which the House approved by a 220-175 margin was better than the legislation the House had started out with, Mr. Greenwood believed the House bill was "still bad."  As a result, Mr. Greenwood said that BIO would continue to oppose the House bill and work with the Senate to pass a bill more favorable to the 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations comprising BIO.

    With regard to those portions of the House bill that BIO finds to be most problematic, Mr. Greenwood began by criticizing the bill’s apportionment of damages provision, which allows a court in an infringement action to calculate a reasonable royalty based on the "economic value attributable to patent’s specific contribution over prior art."  When asked if BIO could offer an acceptable middle ground between the current system and the House’s apportionment of damages provision, Mr. Greenwood replied that the current system "beats anything we have seen in the legislation."

    Mr. Greenwood also found the inequitable conduct and enhanced rulemaking authority provisions of the House bill to be lacking.  With respect to the latter provision, Mr. Greenwood expressed dissatisfaction with the differences between the House and Senate bills (the House bill would retroactively authorize the Patent Office’s new continuation and claims rules and the Senate bill would only grant the Office some fee-setting authority).  While acknowledging that USPTO officials may have been "well intentioned" in passing the new continuation and claims rules, Mr. Greenwood believed that such decisions "should be left to Congress, and not to administrators."  Nevertheless, Mr. Greenwood stressed that BIO was "trying to work amicably with the PTO" with respect to the new rules, and observed that a number of BIO-supported changes to the proposed continuation and claims rules had made their way into the final rule.  Mr. Greenwood concluded by stating that BIO had not taken a position with respect to any legal challenges to the new rules, such as Dr. Tafas’ action (see "Rules Challenger Amends Complaint and Withdraws PI Motion").

    Orange Book Blog, which also participated in the conference call, has reported on Mr. Greenwood’s comments concerning the Biologics Price Competition and Innovation Act of 2007.

  •     By Sherri Oslick

    Lilly
    As reported here, on August 9, Eli Lilly filed suit in the District Court of New Jersey against Actavis Elizabeth in answer to Actavis’ filing of an ANDA (and concomitant Paragraph IV certification) to manufacture a generic version of Lilly’s Strattera®.  Earlier this month, Lilly filed an amended complaint in the case, adding additional ANDA/Paragraph IV filers Glenmark Pharmaceuticals, Sun Pharmaceuticals, Sandoz, Mylan Pharmaceuticals, Apotex, Aurobindo Pharma, Teva Pharmaceuticals, Synthon Laboratories, and Zydus Pharmaceuticals.  Sandoz, as reported here, had previously filed suit against Lilly seeking declaratory judgment of non-infringement and invalidity of the patent at issue.

    Strattera
    Strattera®, or atomoxetine hydrochloride, a norepinephrine reuptake inhibitor, is a non-stimulant medication used in the treatment of Attention-Deficit/ Hyperactivity Disorder (ADHD) in children, adolescents, and adults.  The method of treatment is covered by U.S. Patent No. 5,658,590 ("Treatment of Attention-Deficit/ Hyperactivity Disorder," issued August 19, 1997).  The ‘590 patent is set to expire on May 26, 2017.