• By Sherri Oslick —

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

    Abbott Laboratories et al. v. Sandoz Inc.
    1:12-cv-00103; filed January 30, 2012 in the District Court of Delaware

    • Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
    • Defendant:  Sandoz Inc.

    Infringement of U.S. Patent Nos. 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000) and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Sandoz's filing of an amended ANDA to manufacture a generic version of Abbott's Simcor® (niacin extended release / simvastatin tablets, used to treat hypercholesterolemia).  View the complaint here.


    Enzo Life Sciences Inc. v. Gen-Probe Inc.

    1:12-cv-00104; filed January 30, 2012 in the District Court of Delaware

    Enzo Life Sciences Inc. v. Life Technologies Corp.
    1:12-cv-00105; filed January 30, 2012 in the District Court of Delaware

    Enzo Life Sciences Inc. v. Roche Molecular Systems Inc. et al.
    1:12-cv-00106; filed January 30, 2012 in the District Court of Delaware

    • Plaintiff:  Enzo Life Sciences Inc.
    • Defendants:  Roche Molecular Systems Inc.; Roche Diagnostics Corp.; Roche Diagnostics Operations Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,922,180 ("Oligo- Or Polynucleotides Comprising Phosphate-Moiety Labeled Nucleotides," issued January 31, 2006) based on defendants' manufacture and sale of certain nucleic acid probe products.  View the Gen-Probe complaint here.


    Bayer Healthcare LLC v. Pfizer Inc.

    1:12-cv-00630; filed January 30, 2012 in the Northern District of Illinois

    Infringement of U.S. Patent No. 5,756,506 ("Single High Dose Fluoroquinolone Treatment" issued May 26, 1998) based on Pfizer's planned launch of ADVOCIN™ (single high dose fluoroquinolone, used to treat bovine respiratory disease).  View the complaint here.


    Takeda Pharmaceutical Co., Ltd. et al v. Sandoz, Inc.

    5:12-cv-00446; filed January 27, 2012 in the Northern District of California

    • Plaintiffs:  Takeda Pharmaceutical Co., Ltd.; Takeda Pharmaceuticals U.S.A., Inc.; Takeda Pharmaceuticals LLC; Takeda Pharmaceuticals America, Inc.
    • Defendant:  Sandoz, Inc.

    Infringement of U.S. Patent Nos. 6,462,058 ("Benzimidazole Compound Crystal," issued October 8, 2002), 6,664,276 (same title, issued December 16, 2003), 6,939,971 (same title, issued September 6, 2005), 7,285,668 ("Process for the Crystallization of (R)- or (S)-Lansoprazole," issued October 23, 2007), and 7,790,755 ("Controlled Release Preparation," issued September 7, 2010) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Takeda's Dexilant® (dexlansoprazole, used for the treatment of all grades of erosive esophagitis, maintaining healing of esophagitis, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease).  View the complaint here.


    Allergan, Inc. v. Hi-Tech Pharmacal Co.

    6:12-cv-00043; filed January 27, 2012 in the Eastern District of Texas

    Infringement of U.S. Patent No. 7,851,504 ("Enhanced Bimatoprost Ophthalmic Solution," issued December 14, 2010) following a Paragraph IV certification as part of Hi-Tech's filing of an ANDA to manufacture a generic version of Allergan's Lumigan® (0.01% bimatoprost ophthalmic solution, used to treat lower intraocular eye pressure in people with open-angle glaucoma or ocular hypertension).  View the complaint here.


    Exelixis, Inc. v. Kappos

    1:12-cv-00096; filed January 27, 2012 in the Eastern District of Virginia

    Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,989,622 ("Phosphatidylinositol 3-kinase Inhibitors and Methods of Their Use," issued August 2, 2011).  View the complaint here.


    Valeant International (Barbados) SRL et al. v. Spear Pharmaceuticals, Inc.

    2:12-cv-00043; filed January 26, 2012 in the Middle District of Florida

    • Plaintiffs:  Valeant International (Barbados) SRL; A.P. Pharma, Inc.
    • Defendant:  Spear Pharmaceuticals, Inc.

    Infringement of U.S. Patent No. 6,670,335 ("Fluorouracil-Containing Formulation," issued December 30, 2003) following a Paragraph IV certification as part of Spear's filing of an ANDA to manufacture a generic version of Valeant's Carac® (fluorouracil 0.5% cream, used to treat multiple actinic or solar keratoses of the face and anterior scalp).  View the complaint here.


    Astrazeneca AB et al. v. Torrent Pharmaceuticals Ltd. et al
    .
    3:12-cv-00506; filed January 26, 2012 in the District Court of New Jersey

    • Plaintiffs:  Astrazeneca AB; Aktiebolaget Hassle; Astrazeneca LP; KBI Inc.; KBI-E Inc.
    • Defendants:  Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.

    Infringement of U.S. Patent Nos. 5,714,504 ("Compositions," issued February 3, 1988), 5,877,192 ("Method for the Treatment of Gastric Acid-Related Diseases and Production of Medication Using (-)Enantiomer of Omeprazole," issued March 2, 1999), and 6,875,872 ("Compounds," issued April 5, 2005), following a Paragraph IV certification as part of Torrent's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  View the complaint here.

  • Calendar

    February 8, 2012 – Corporate Intellectual Property Law Conference (Law Bulletin Publishing Co.) – Chicago, IL

    February 14, 2012 – New Supplemental Examination: USPTO Outlines New Rules (Strafford) – 1:00 – 2:30 pm (EST)

    February 13-14, 2012 – China IP Counsel Forum (C5) – Shanghai, China

    February 15, 2012 – Effects of the AIA on Valuation, Licensing & Acquisitions (American Intellectual Property Law Association) – 12:30 – 1:30 pm (Eastern)

    February 17, 2012 – Invention Disclosures and the America Invents Act (Intellectual Property Law Association of Chicago) – Chicago, IL

    February 21-22, 2012 – Biotech & Pharmaceutical Patenting*** (IBC Legal) – Munich, Germany

    February 22-23, 2012 – EU Pharma Law & Regulation*** (C5) – London, England

    February 22-24, 2012 – Intensive Patent Law Training Seminar (Chisum Patent Academy) – New York, NY

    February 23, 2012 – Gene Patenting in the U.S. after Myriad (Navigant) – Chicago, IL

    February 27-29, 2012 – Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) – New York, NY

    February 28-29, 2012 – Medical Device Patents*** (American Conference Institute) – Boston, MA

    March 14-15, 2012 – Biotech Patenting (C5) – Munich, Germany

    March 20-21, 2012 – FDA Boot Camp*** (American Conference Institute) – New York, NY

    March 26-27, 2012 – PTO Procedures under the America Invents Act*** (American Conference Institute) – New York, NY

    March 28-30, 2012 – 27th Annual Intellectual Property Law Conference (American Bar Association (ABA) Section of Intellectual Property Law) – Arlington, VA

    ***Patent Docs is a media partner of this conference or CLE

  • Navigant

    Navigant will be hosting a IP roundtable on the "Gene Patenting in the U.S. after Myriad" on February 23, 2012 from 12:00 to 1:30 pm at Navigant's offices in Chicago, IL.  The roundtable will be moderated by Thomas J. Filarski of Steptoe & Johnson LLP.  There is no registration fee for the roundtable, but those interested in registering for the roundtable can do so here.  To encourage maximum interaction, enrollment will be limited to 25 persons.  Additional information regarding the roundtable can be found here.

  • Strafford #1

    Strafford will be offering a webinar entitled "New Supplemental Examination: USPTO Outlines New Rules" on February 14, 2012 from 1:00 – 2:30 pm (EST).  Scott A. McKeown of Oblon Spivak McClelland Maier & Neustadt and Professor Lisa A. Dolak of Syracuse University College of Law will discuss the new supplemental examination proceeding, the mechanics of the procedure and the considerations that may govern decisions to use it over other post grant options.  The panel will also examine the ethics implications, including questions that must await USPTO and judicial developments relating to supplemental examination.  The webinar will review the following questions:

    • What are the mechanics of using the supplemental examination process?
    • What are the primary factors for deciding whether to use supplemental examination to consider, reconsider, or correct information relevant to a patent?
    • What are the ethical risks that can arise in the supplemental examination process — and how can counsel avoid ethics violations?

    An interactive Q&A session will follow the presentation.

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

  • IPLAC

    The Intellectual Property Law Association of Chicago (IPLAC) Patent Agents Committee will be offering a lunch and learn event on "Invention Disclosures and the America Invents Act" on February 17, 2012 from 12:00 to 3:00 pm (Central) in Room 1200A at the John Marshall Law School in Chicago, IL.  Timothy J. Engling of Miller Canfield and John P. Wappel of Caterpillar Inc. will discuss invention disclosures and nuances for disclosures related to the America Invents Act.

    The registration fee for the seminar is $20 for IPLAC members and $25 for non-members.  IPLAC is an Accredited CLE Provider, and it is anticipated that the program will be eligible for 1.5 hours of CLE credit.  Those interested in registering for event can do so here.

  • AIPLA

    The American Intellectual Property Law Association (AIPLA) will be offering a web-based program on the "Effects of the AIA on Valuation, Licensing & Acquisitions" on February 15, 2012 from 12:30 – 1:30 pm (Eastern).  Jeffrey Whittle and Michael Samardzija of Bracewell & Giuliani LLP will explore how the numerous changes to the patent system might affect valuation of patents, examine the various risks the new legislation provides in licensing and acquisition of patents, and provide ways to address the various risks from the licensor/licensee and buyer/seller perspectives.

    The registration fee for the program is $65 (AIPLA member rate) or $95 (non-member rate).  Those interested in registering for the program, can do so here.

  • By Donald Zuhn —

    NVCA

    Last month, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for 2011.  The report, which is prepared by NVCA and PriceWaterhouseCoopers using data from Thomson Reuters, indicates that venture capitalists invested $28.4 billion in 3,673 deals in 2011, which constituted a 22% increase in dollars and a 4% increase in deals as compared with 2010.  The amount of dollars invested in 2011 constituted the third highest annual investment total in the past ten years.

    Pwc

    The annual increases in dollars and deals for 2011 were achieved despite a 10% decrease in dollars and 11% decrease in deals in the fourth quarter as compared with the third quarter.  In particular, funding dropped from $7.3 billion in the third quarter to $6.6 billion in the fourth quarter and the number of deals dropped from 953 in the third quarter to 844 in the fourth quarter.

    Funding in the biotech sector in 2011 matched venture funding overall, with the biotech sector receiving $4.7 billion — a 22% increase over 2010 funding.  In terms of dollars invested, the biotech industry placed second among the industries tracked by the NVCA (the software industry took the top spot, collecting $6.7 billion in 2011).  Biotech deals in 2011 were up 9% to 446.  For the fourth quarter, biotech funding was up 10% to $1.3 billion and the number of deals rose 6% to 111 as compared with the third quarter.  Overall, thirteen of the seventeen sectors tracked by the NVCA saw increases in dollars invested in 2011.

    Thomson Reuters

    Tracy Lefteroff, the global managing partner of the venture capital practice at PricewaterhouseCoopers noted that while "venture capital investing in 2011 exceeded 2010 levels and ranks in the top three years for VC investing in the past decade," venture capitalists "are acting prudently and not chasing excessive valuations."  She predicted that "despite the increase in investing, we're unlikely to see these sectors overheat like we saw in the 1999 to 2000 era."  NVCA president Mark Heesen pointed out that "[w]hile venture capital investment grew in 2011, it is important to note that deal volume growth did not keep pace with dollar growth."  He noted that in some industries, including life sciences, venture capitalists being forced "to fuel their existing portfolios longer and at greater investment levels than in the past," which explained the lower deal volume.

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

    • "Life Sciences Venture Funding Drops in Third Quarter," October 27, 2011
    • "Life Sciences Venture Funding up 37% in Second Quarter," August 1, 2011
    • "VentureSource Reports 35% Increase in 1Q Venture Funding," April 26, 2011
    • "NVCA Reports Modest Gains in First Quarter Venture Funding," April 19, 2011

    • "NVCA Reports 31% Drop in Venture Funding for Third Quarter," October 17, 2010

    • "NVCA Reports 34% Increase in Venture Funding for Second Quarter," July 22, 2010

    • "NVCA Report Shows First Quarter Drop in Venture Funding," April 20, 2010

    • "Biotech/Pharma Financing Improving, R&D Spending Up," August 31, 2009
    • "NVCA Study Shows Increase in Third Quarter Venture Funding," October 23, 2009

    • "First Quarter Venture Capital Funding at 12-Year Low," April 23, 2009

    • "NVCA Study Shows Decline in 2008 Investment; BIO Study Predicts Biotech Rebound in 2009," February 16, 2009

    • "NVCA Predicts Another Slow Year for Venture-backed Businesses in 2009," December 18, 2008

  • By Donald Zuhn —

    USPTO Seal

    On Monday, the U.S. Patent and Trademark Office issued a notice in the Federal Register (77 Fed. Reg. 4509) announcing that the Patent Public Advisory Committee (PPAC) will be holding two public hearings in February regarding proposed patent fees.  The public hearings are being held pursuant to § 10 of the Leahy-Smith America Invents Act, which concerns the Office's fee setting authority.  Under that section, the Director is permitted to set or adjust any fee established, authorized, or charged under Title 35 (but "only to recover the aggregate estimated costs to the Office for processing, activities, services, and materials relating to patents").

    AIA § 10 also outlines the process whereby the Director is allowed to set or adjust such fees.  In particular, the Director must submit a proposed fee change to the PPAC not less than 45 days before publishing the proposed fee in the Federal Register, after which the PPAC shall have 30 days to deliberate, consider, and comment on the proposal as well as hold a public hearing on the proposal.  The Director shall then consider and analyze the PPAC's comments, advice, or recommendations before setting or adjusting the fee.  AIA § 10 also requires that the Director provide the public with a 45-day period in which to comment on any fee change, and specifies that fee changes shall not become effective until 45 days after the final rule regarding such change is published in the Federal Register (in order to give Congress an opportunity to enact a law disapproving of the fee change).

    In Monday's notice, the Office indicated that it is planning to set or adjust fees pursuant to its § 10 fee setting authority.  In order to comply with the requirements of § 10, the Office will be holding two public hearings on proposed patent fees.  The hearings will take place on from 8:00 am to 3:00 pm (EST) on February 15 in the Madison Auditorium, 600 Dulany Street, Alexandria, Virginia 22314; and from 8:00 am to 3:00 pm (PST) on February 23, 2012 at the Sunnyvale Public Library, 665 W. Olive Avenue, Sunnyvale, California 94086.  Both public hearings will be made available via webcast (details forthcoming).

    The notice indicates that the Office will publish a proposed patent fee schedule and related supplementary information for public viewing on the USPTO's AIA webpage no later than February 7, 2012.  Following the public hearings, the Office intends to publish a notice of proposed rulemaking in the Federal Register setting forth the proposed patent fees, after which the public will be afforded an opportunity to comment on the fees again.

    Individuals wishing to present oral testimony at either hearing must request an opportunity to do so in writing no later than February 8, 2012.  Requests to testify must be submitted by e-mail to Jennifer Lo at Jennifer.Lo@uspto.gov, and should include:  (1) the name of the person wishing to testify; (2) the person's contact information (telephone number and e-mail address); (3) the organizations the person represents, if any; and (4) an indication of the amount of time needed for the testimony.

    Those wishing to submit written comments must do so on or before February 29, 2012.  Written comments can be sent by e-mail to fee.setting@uspto.gov or by regular mail addressed to:  United States Patent and Trademark Office, Mail Stop CFO, P.O. Box 1450, Alexandria, VA 22313–1450, ATTN: Michelle Picard.

  • By Kevin E. Noonan —

    Washington - Capitol #3

    The Leahy-Smith America Invents Act ("AIA") changes U.S. patent law in many ways, notably by converting our patent system to a "first inventor to file" system.  However, the language of the new statute is not always "pelucidly clear" in achieving this change; one of the areas of murkiness involves the meaning of "public use" and "on sale" under  § 102(a)(1):

    § 102. Conditions for Patentability; Novelty

    (a)  A person shall be entitled to a patent unless —

    (1)  the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention;

    (2)  the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.

    One issue with this statutory language is whether "public use" or "on sale" encompasses uses that are in fact secret but are involved in producing a commercial product.  Such a "secret" use has precluded patent eligibility since Metallizing Engineering Co. v. Kenyon Bearing and Auto Parts Co., 153 F.2d 516 (2d Cir. 1946) (Hand, J.), where the Court's opinion set forth the rationale for precluding patenting under these circumstances:

    [I]t is a condition upon an inventor's right to a patent that he shall not exploit his discovery competitively after it is ready for patenting; he must content himself with either secrecy, or legal monopoly.

    This reasoning has proven persuasive to the Federal Circuit, which has held that secret commercial exploitation of an invention begins the one-year deadline for filing an application under current § 102(b).  Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1382 (Fed. Cir. 2005).

    There are ways of parsing the statute that can construe the language of new § 102(a)(1) to eliminate this effect of secret commercial practice of products or processes:

    § 102. Conditions for Patentability; Novelty

    (a) A person shall be entitled to a patent unless —

    (1) the claimed invention was

    (i) patented,

    (ii) described in a printed publication, or

    (iii) in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; . . .

    Under this reading, the "public use" must be public, and the sale must also be something that is not kept as a trade secret (which would permit processes and intermediates that are not sold to be patented even after extensive commercial exploitation).  Alternatively, there are canons of statutory construction that support the countervailing position, that the statute does not eliminate forfeiture of patent-eligibility by secret commercial use, including the concept that when Congress intends such a dramatic shift in the law it does so explicitly (one of the grounds used by the Supreme Court in interpreting the metes and bounds of university's patent rights under the Bayh-Dole Act in Stanford v. Roche).

    The problem is that there is precious little in the record to support either view.  For example, Senator Leahy addressed the question in the Congressional Record as follows:

    One of the implications of the point we are making is that subsection 102(a) was drafted in part to do away with precedent under current law that private offers for sale or private uses or secret processes practiced in the United States that result in a product or service that is then made public may be deemed patent-defeating prior art.  That will no longer be the case.  In effect, the new paragraph 102(a)(1) imposes an overarching requirement for availability to the public, that is a public disclosure, which will limit paragraph 102(a)(1) prior art to subject matter meeting the public accessibility standard that is well-settled in current law, especially case law of the Federal Circuit.

    Unfortunately, these remarks were made one day after the enactment of S. 23, making it difficult to argue that the Senate intended the outcome advanced by Senator Leahy.  Senator Kyl is on record (on the date of enactment of the AIA) in supporting this position (albeit less clearly than Senator Leahy):

    When the committee included the words "or otherwise available to the public" in section 102(a), the word "otherwise" made clear that the preceding items are things that are of the same quality or nature.  As a result, the preceding events and things are limited to those that make the invention "available to the public."  The public use or sale of an invention remains prior art, thus making clear that an invention embodied in a product that has been sold to the public more than a year before an application was filed, for example, can no longer be patented . . . .  But public uses and sales are prior art only if they make the invention available to the public.

    How this portion of the statute is interpreted will be particularly important to the biotechnology and pharmaceutical industries because the processes involved in making their products may not be patented (or at least not comprehensively so) and there are advantages in keeping some of these processes as trade secrets.  However, there is also the risk that another will file for patent protection for a method that will be infringed by such a process kept as a trade secret; indeed, fear of this outcome (in industries in addition to pharma and biotech) was a driving force behind the prior user rights provisions (Section 5 of the Act, codified as 35 U.S.C. § 273).  Recognition of the relationship between these two sections of the AIA, however, provides a clue for whether new § 102(a)(1) maintains or eliminates the traditional forfeiture of patent eligibility by secret use of a commercial process or product.

    The prior user rights provisions of the AIA reads (in relevant part) as follows:

    35 U.S.C. 273 Defense to infringement based on earlier inventor.

    (a)  IN GENERAL.–A person shall be entitled to a defense under section 282(b) with respect to subject matter consisting of a process, or consisting of a machine, manufacture, or composition of matter used in a manufacturing or other commercial process, that would otherwise infringe a claimed invention being asserted against the person if—

    (1)  such person, acting in good faith, commercially used the subject matter in the United States, either in connection with an internal commercial use or an actual arm's length sale or other arm's length commercial transfer of a useful end result of such commercial use; and

    (2)  such commercial use occurred at least 1 year before the earlier of either—

    (A)  the effective filing date of the claimed invention; or

    (B)  the date on which the claimed invention was disclosed to the public in a manner that qualified for the exception from prior art under section 102(b). . . .

    Thus, the prior user right cannot be asserted if the commercial use was less than one year prior to the effective filing date of the claimed invention.  This provision makes sense if "secret" use of a product or process has the same consequences under new § 102(a)(1) as it did under old § 102(b):  to create a bar against patenting such a process or use against the inventor who decides to keep the process or product as a trade secret rather than seeking patent protection.  Under this interpretation, the one-year limit is needed to prevent such an inventor from attempting to patent and thus defeat the rights of the second inventor who files, since after one year that right (as to the prior user) has been forfeited.  This implies that if the prior user files within one year the "secret" use may be deemed a public disclosure that would defeat a later filer (just as disclosure of an invention on a public website would be deemed a prior public disclosure that would bar a later filer provided that the first to disclose filed for patent protection within one year of the disclosure).  This construction comports with another canon of statutory construction, that the several provisions of the Act are intended to be consistent and to be read to produce consistent results.  This reading is also in line with statements in the recently published Report from the Patent and Trademark Office on the prior user rights defense that the changes in the AIA regarding the "first inventor to file" regime created an unfairness to prior users (see "USPTO Issues Report on Prior User Rights").  While the record is unclear and the expectation is that these questions must be decided in litigation (unless Congress passes technical amendments to expressly set forth their intent), the interpretation set forth here is at least a starting point for considering the consequences of deciding to keep commercially valuable processes or products as trade secrets rather than protecting them by patenting under the AIA.

    Hat tip to Steven Lendaris of Baker Botts.  Adapted from his talk, "The America Invents Act: Are Secret Uses/Sales Still Prior Art" given at ACI's Comprehensive Guide to Patent Reform for Life Sciences Companies, New York, January 31, 2012.

  • By Donald Zuhn —

    USPTO Seal

    Last November, officials from the U.S. Patent and Trademark Office indicated that ten notices of proposed rulemaking to implement various provisions of the Leahy-Smith America Invents Act were being drafted and vetted by the Office, and that the notices would be published in January 2012.  With January drawing to a close, the Office has thus far published five of these notices.  In previous posts, we have discussed three of the notices (concerning implementation of the AIA's miscellaneous post patent provisions, preissuance submissions provision, and provisions on disciplinary proceedings — see links below).  A subsequent post will address a recently published notice concerning the implementation of the AIA's supplemental examination provisions (77 Fed. Reg. 3666).  Today, we address the Office's notice on "Changes To Implement the Inventor’s Oath or Declaration Provisions of the Leahy-Smith America Invents Act " (77 Fed. Reg. 982).

    The 22-page notice proposes changes that are intended to revise and clarify the rules of practice relating to the inventor's oath or declaration, assignments containing oath or declaration statements from inventors, and oaths or declarations signed by parties other than the inventors, as well as revise and clarify the rules of practice for powers of attorney and prosecution of an application by an assignee.  In particular, the notice proposes changes to the rules to implement AIA § 4, which amends 35 U.S.C. §§ 115 and 118 to change the practice regarding an inventor's oath or declaration, and AIA § 20, which amends, inter alia, 35 U.S.C. §§ 116, 184, 251, and 256 to remove the "without any deceptive intention" language.  A list of the specific changes to each of these sections can be found on pages 982-84 of the notice.

    Following the list of specific changes to Title 35, the notice provides a general discussion regarding the implementation of AIA §§ 4 and 20.  With regard to these changes, the notice indicates that amended § 115 permits the required inventor statements (i.e., that the application was made or was authorized to be made by the affiant or declarant, and that the individual believes himself or herself to be the original inventor or an original joint inventor of a claimed invention in the application) to be made in an oath or declaration under 35 U.S.C. § 115(a), a substitute statement under 35 U.S.C. § 115(d), or an assignment under 35 U.S.C. § 115(e).  Because amended § 115 no longer requires an inventor to identify his or her country of citizenship, the Office will no longer require this information to be included in the oath or declaration.

    The Office also proposes changes to the rules that will allow an assignee, a party to whom the inventor is legally obligated to assign the invention, or a party who otherwise has a sufficient proprietary interest to provide a substitute statement with respect to an inventor who is deceased, is legally incapacitated, cannot be found or reached after diligent effort, or refuses to sign the oath or declaration.  The Office further proposes changes to the rules to allow inventors to make the required statements in an assignment executed by the inventor and recorded in the Office (including a proposal to require that the assignment cover sheet identify the assignment as also being an oath or declaration).

    While the AIA permits the Office to delay requiring an oath or declaration until allowance, the Office determined that it would be "better for the examination process and patent pendency to continue to require the oath or declaration during preexamination."  For example, the Office noted that it "must know the identity of the inventors to determine what prior art may be applied against the claimed invention or whether to issue a double patenting rejection."  The notice indicates that the Office considered discontinuing the practice of charging a surcharge for late filing of an oath or declaration, but states that "the cost of the special processing required for such applications should be borne by those applicants who require special processing and not by applicants whose applications are complete on filing."

    With regard to powers of attorney, the Office proposes changes to the rules that will:

    • Provide for the carryover of a power of attorney in continuation and divisional applications, and in continuation-in-part applications where inventorship is the same as in the immediate prior application;
    • Permit practitioners who have acted only in a representative capacity in an application to change the correspondence address after a patent has issued;
    • Accept the signature of a practitioner of record on a statement under 37 C.F.R. § 3.73(b) on behalf of an assignee without requiring further evidence of the practitioner's authority to act on behalf of the assignee;
    • Provide a procedure for handling conflicts between different purported assignees attempting to control prosecution; and
    • Harmonize the practice regarding foreign and domestic priority claims by requiring both types of claims to be set forth in an application data sheet.

    A lengthy discussion of the specific changes to the rules to implement the above changes can be found on pages 985-96 of the notice.  Additional discussion of the rules changes, as well as revised versions of the affected rules (see pages 998-1003) can be found in the Office's Federal Register notice (77 Fed. Reg. 982).

    Comments regarding this notice can be submitted by e-mail to oath_declaration@uspto.gov; by regular mail addressed to:  Mail Stop Comments — Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Hiram H. Bernstein, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal.  The deadline for submitting comments is March 6, 2012.  Additional information regarding the submission of comments can be found in the Office's Federal Register notice (77 Fed. Reg. 982).

    For information regarding the Office's implementation of other AIA provisions, please see:

    • "USPTO Proposes Rules Changes for Implementing AIA Provisions — Statute of Limitations Provisions for Office Disciplinary Proceedings," January 16, 2012
    • "USPTO Proposes Rules Changes for Implementing AIA Provisions — Preissuance Submissions Provision," January 12, 2012
    • "USPTO Proposes Rules Changes for Implementing AIA Provisions — Miscellaneous Post Patent Provisions," January 11, 2012