Presentation on theme: "Indianapolis Bar Association: 2009-2010 Year in Review Patent Law and Practice Chuck Schmal Sponsored by the Intellectual Property Law Section."— Presentation transcript:
Indianapolis Bar Association: Year in Review Patent Law and Practice Chuck Schmal Sponsored by the Intellectual Property Law Section
Overview Patent Office Procedure Patent Term Adjustment Ownership Inequitable Conduct Ethics Rules Other Notable Cases Note: The following topics are just a small sample of recent cases and procedures.
Patent Office Practice
Bilski Most Important Change of the Year Appeals Rules Continuation & Claims Rules
Most Important Change of the Year August 13, David Kappos- New Director of the USPTO Bilski Appeals Rules Continuation & Claims Rules
Change in Attitude Launches a Blog and Increases Town Hall Meetings Claim and Con Rules Rescinded- October 8, 2009 Ombudsman Program- April 6, 2010 PKI Certificates- now can have multiple employees of your firm e-file or access private PAIR on your behalf (even at the same time) –FAQs published.
Change in Attitude On the subject of quality, there has been speculation in the IP community that examiners are being encouraged to reject applications because a lower allowance rate equals higher quality. Let's be clear: patent quality does not equal rejection. In some cases this requires us to reject all the claims when no patentable subject matter has been presented. It is our duty to be candid with the applicant and protect the interests of the public. In other cases this means granting broad claims when they present allowable subject matter. In all cases it means engaging with the applicant to get to the real issues efficientlywhat we all know as compact prosecution.-- August to Examiners
Rescinds Continuation and Claims Rules The USPTO should incentivize innovation, develop rules that are responsive to its applicants needs and help bring their products and services to market......These regulations have been highly unpopular from the outset and were not well received by the applicant community. In taking the actions we are announcing today, we hope to engage the applicant community more effectively on improvements that will help make the USPTO more efficient, responsive, and transparent to the public. --October 08, 2009 Press Release: USPTO Rescinds Controversial Patent Regulations Package Proposed by Previous Administration
Ombudsman Pilot Program Ombudsman- used when unable to resolve application-processing issue through USPTO's existing channels –Example, Examiner and SPE do not address new argument or amendment and not returning phone calls. –Recommended to contact the SPE first. –Has to concern a specific application.
Ombudsman Pilot Program Fill out electronic form at: When you first speak with Ombudsman, will be asked whether or not you want it to be confidential –Confidential- Ombudsman will simply log the complaint (log used to look for trends)
Compact Prosecution Expanded and Revised 1st Action Interview Pilot Program Accelerated Examination Revised Examiner Count System
1 st Action Interview Had two versions- Original and Enhanced Sadly, ended April 1, 2010, but likely implement a similar program in the future. Expanded to all art units but had differing filing date requirements
1 st Action Interview E-File the request for the 1 st Action Interview Program Restriction- must elect Examiner Conducts Prior Art Search and Sends a list of prior art citation to the applicant Afterwards, Applicant has to within 1 month or 30 days: File a request not to have a 1 st Action Interview Schedule Interview and file proposed amendments
1 st Action Interview
Accelerated Examination Green Technology- still available until December 10, 2010 Small Entity- still available until June 30, 2010
Accelerated Examination- Green Technology Green Technology Pilot Program Introduced just before United Nations Climate Change Conference in Copenhagen, Denmark 1 st 3,000 Green Technology Applications with petition receive accelerated examination
Accelerated Examination- Green Technology Petition Must be filed before Dec. 10, 2010 (12 Month Pilot Program) What is Green technology- application directed to: environmental quality, energy conservation, development of renewable energy resources or greenhouse gas emission reduction What you get- accelerated examination Advanced out of turn without all of the requirements of accelerated examination (e.g., ESD, etc.)
Accelerated Examination- Small Entity Program Apparently Extended to June 30, 2010 Requirements Small Entity with 2 or more applications Applications filed before October 1, 2009 Expressly abandon one of the applications File a petition for accelerated examination -($130 fee waived) What you got- accelerated examination Advanced out of turn without all of the requirements of accelerated examination (e.g., ESD, etc.)
Revised Examiner Count System Old System New System February 18, 2010
Proposed Procedural Change- Comment Requested Deferred Examination (light) –PTO floating extension to provisional period through missing parts procedural change –After provisional, non-provisional filing receives notice with 12-month non-extendable deadline –Notice demands search/exam fees, surcharge –Ideally, provides applicant with 24 months to decide whether invention is commercially viable
Proposed Rules Non-provisional filing must –Include basic filing fee ($330; $165 small- entity) –Have executed oath/declaration (eventually) –Be without or rescind nonpublication request –Be in condition for publication (37 CFR 1.211(c)) No tolling of 12-month period under Paris Convention
Proposed Rules Asserted Advantages –More publications, i.e. provisionals that would not be filed otherwise, non-provisionals w/o nonpublication requests –Unneeded applications out of system, relieving applicants financial, PTOs workload burdens –Focus applicant resources on commercialization rather than non-provisional filing
Proposed Rules Potential Downsides –No tolling of 12-month period under Paris Convention –Can get a longer period by filing a PCT application –Search & Examination Fees are small in comparison to attorney costs
Appeals Controversial Appeals Rules- reopened for comment Streamlined Noncompliant Appeal Brief Review Process Claims- how to handle appealed and non-appealed rejections/claims
Appeals Controversial Proposed Appeals Rules- reopened comments Streamlined Appeal Brief Review Process Chief Judge of BPAI (or his designee) has now sole responsibility for determining whether appeal briefs comply with regulations, and will complete the Hopefully, it will reduce the number of non-compliant appeal briefs Use checklist at: ance_noncompliant_briefs.jsp ance_noncompliant_briefs.jsp
Appeals Claims Reviewed During Appeal Proposed rule to treat non-appealed rejected claims considered canceled. Ex Parte Frye: BPAIs Standard of Review of Examiners Rejections the Board reviews the particular finding(s) contested by an appellant anew in light of all the evidence and argument on that issue. [i]f an appellant fails to present arguments on a particular issue – or, more broadly, on a particular rejection – the Board will not, as a general matter, unilaterally review those uncontested aspects of the rejection, and such unasserted arguments may be deemed to have been waived.
Patent Term Adjustment
Quick Patent Term Adjustment Refresher 35 U.S.C. §154(b)(1) Periods (A) Guarantee of prompt USPTO responses- 14 months for USPTO to send an Office Action or Notice of Allowance (plus various 4 month periods)- Examination Delays (B) Guarantee of no more than 3-year application pendency- USPTO fails to issue patent 3 years after actual filing date No Double Counting When Periods Overlap § 154(b)(2)(A) "[t]o the extent that periods of delay attributable to grounds specified in paragraph (1) overlap, the period of any adjustment granted under this subsection shall not exceed the actual number of days the issuance of the patent was delayed."
Wyeth v. Kappos (Fed. Cir. 2009) Issue: When does the overlap occur? USPTO 37 CFR § 1.703(f)- B guarantee period starts at the time of the filing of the application, not 3 years after the filing date. You only get the greater of the A or B periods USPTO – 3 Years PTA Overlap Here Overlap Here Filing date 14 mo. date Office Action issued 3 year date Issue fee paid 4 mos. from issue fee payment, patent should issue Issue date A Delay B Delay A Delay
Wyeth v. Kappos (Fed. Cir. 2009) Issue: When does the overlap occur? Wyeth A & B Overlap only occurs after 3 years from the filing date. (A+B Formula) 1 Year USPTO – 3 Years PTA Filing date 14 mo. date 26 mo. Office Action issued 3 year date Issue fee paid 4 mos. from issue fee payment, patent should issue 6 years issue date A Delay B Delay A Delay Overlap Here
Wyeth v. Kappos (Fed. Cir. 2009) Federal Circuit Agrees with Wyeth "no 'overlap' happens unless the violations occur at the same time," … "[b]efore the three-year mark, no 'overlap' can transpire between the A delay and the B delay because the B delay has yet to begin or take any effect." However, "[u]nder the PTOs strained interpretation, B delay can occur anytime after the application is filed," which the Court determined "cannot be reconciled with the language of the statute" (emphasis by panel).
Wyeth v. Kappos (Fed. Cir. 2009) Federal Circuit A & B overlap only occurs after 3 years from the filing date. (A+B Formula) 1 Year USPTO – 3 Years PTA Filing date 14 mo. date 26 mo. Office Action issued 3 year date Issue fee paid 6 years issue date A Delay B Delay A Delay Overlap Here 4 mos. from issue fee payment, patent should issue
Wyeth v. Kappos (Fed. Cir. 2009) USPTO Response USPTO will be processing recalculation requests under an interim procedure that is available to a patentee whose patent issues prior to March 2, 2010, and who requests it no later than 180 days after the issue date. This procedure is available only for alleged errors in calculation that are specifically identified in Wyeth. Information on requesting a recalculation of patent term is on the USPTO Web site at
Wyeth v. Kappos (Fed. Cir. 2009) USPTO Wyeth PTA Form PTO/SB/131
Japan Tobacco Petition USPTO Miscalculating Period B for PCT 371 National Stage Applications Originally, USPTO considered the B Period filing date= when an international applications fulfilled the requirements of 35 U.S.C. § 371 (e.g., filed signed Oath/Dec.). BUT, 37 C.F.R. § 1.702(b) states that "the term of an original patent shall be adjusted if the issuance of the patent was delayed due to the failure of the Office to issue a patent within three years after the date on which the application was filed under 35 U.S.C. 111(a) or the national stage commenced under 35 U.S.C. 371(b) or (f) in an international application. Section 371(b) states that subject to § 371(f), "the national stage shall commence with the expiration of the applicable time limit under article 22 (1) or (2), or under article 39 (1)(a) of the [PCT]. = 30 Month Chapter II Deadline So the B-Period filing date for 371 national stages should be the 30-Month Chapter II deadline (if filed under 371(b)-- more later)
Japan Tobacco Petition USPTO USPTO relents- B-delay should be calculated based on the date on which the national stage commenced, not the date on which the requirements of § 371(c) were fulfilled. Chap II Deadline (30 Months) File Signed Declaration- satisfy 371(c) 3-Year B-Period
Japan Tobacco Petition PCT Patent Term Landmines B-Period Delay Landmine- Early 371 Nationalization If Nationalize under 371 before 30-month chapter II deadline and satisfy 371(c) requirements (e.g., pay fees, signed Declaration, etc.), you still need to expressly request early processing under 371(f) to get the nationalization date for B-Delay filing date. If not, B-Delay filing date will be based on the Chapter II (30-month) deadline & not the earlier nationalization date. Contrast regular utility or bypass CON- B-Period filing date is the actual filing date of the application.
Japan Tobacco Petition B-Delay Period Landmine Nationalize PCT Application before the Chapter II Deadline -Satisfy 371(c)- file signed declaration, etc. -Expressly request early processing (check the box on form) Chap II Deadline (30 Months) 3-Year B-Period Nationalize B-Delay filing date starts before Chapter II Deadline
Japan Tobacco Petition B-Delay Period Landmine –Nationalize PCT Application before the Chapter II Deadline BUT Fail to satisfy 371(c) OR Fail to expressly request early examination Chap II Deadline (30 Months) File Signed Declaration- satisfy 371(c) 3-Year B-Period Nationalize B-Delay filing date starts on Chapter II Deadline
Japan Tobacco Petition B-Delay Period Landmine- COMPARE Instead file via the bypass CON route BUT -Fail to file signed declaration OR -Fail to expressly request early examination Chap II Deadline (30 Months) File Signed Declaration 3-Year B-Period Bypass CON Filing Date B-Delay filing date starts before Chapter II Deadline
Japan Tobacco Petition PCT Patent Term A-Delay Landmines A-Delay Date is still based on fulfillment of national requirements under 371(c). For example, if you do not file a signed declaration when the PCT application is nationalized, you lose A-term until you file the signed declaration. Contrast to a regular utility or bypass CON- where you do not lose A-term so long as you file the signed declaration within 3-months of Notice to File Missing Parts
A-Delay Period Landmine Nationalize PCT application under 371 -Fail to file signed declaration with nationalization Japan Tobacco Petition Chap II Deadline (30 Months) File Signed Declaration Nationalize A-Delay- lose term- until file signed Declaration Lose Term A-Period
Japan Tobacco Petition A-Delay Period Landmine- COMPARE Instead file via the bypass CON route Fail to file signed declaration when application filed File signed declaration 1-month after missing parts deadline Chap II Deadline (30 Months) File Signed Declaration w/ 1-Month EOT + surcharge Bypass CON Filing Date DO NOT LOSE ANY A-TERM! 2 Month Deadline For Missing Parts A-Period
PCT- 371 Nationalization or Bypass CON? What is the best way to nationalize a PCT ? Answer: Bypass CON!!! 371 Nationalization Bypass CON Simplicity PDX Patent Term US Restriction...
Assignments and Ownership
Stanford v. Roche (Fed. Cir. 2009) Patented Technology o Method of quantifying HIV virus levels in human blood samples and correlating to the effectiveness of antiretroviral drugs. History o One of the named inventors (Holodniy) of the patents at issue signed a Copyright and Patent Agreement ("CPA") upon joining laboratory at Stanford. o Holodniy visited Cetus to learn the technology. Holodniy signed a Visitor's Confidentiality Agreement ("VCA"). o Research for the technology at Stanford was funded by the National Institutes of Health ("NIH"). o Stanford filed the applications for the patents at issue – the '730, '705 and '041 patents.
Stanford v. Roche (Fed. Cir. 2009)
Procedural History o Stanford sues Roche for patent infringement. o Roche: Stanford lacks standing - Roche owns, has a license for, and/or a shop right on the asserted patents. District Court o Roche's ownership was barred by California's statute of limitation and the Bayh-Dole Act. o Roche's license claims fail because Stanford never consented to Roche's acquisition of Cetus. o Roche lacked shop right to the patents.
Stanford v. Roche (Fed. Cir. 2009) Federal Circuit o Although Roche claiming ownership was barred by California's statute of limitation, under California law, "a defense may be raised at any time, even if the matter alleged would be barred by a statute of limitations if asserted as the basis for affirmative relief" (citation omitted). Similar reasoning applies to laches and equitable estoppel. o Thus, Roche can assert its ownership as a bar to Stanford's standing.
Stanford v. Roche (Fed. Cir. 2009) Federal Circuit o Which law to apply? Normally questions of ownership are state law issues. Exception: questions of whether a patent assignment clause creates an automatic assignment or merely an obligation to assign - Federal Circuit Law applies.
Stanford v. Roche (Fed. Cir. 2009)
Federal Circuit o Was Holodniy's CPA with Stanford an automatic assignment? Language: "I agree to assign and confirm in writing to Stanford..." is a mere promise to assign. Stanford's invention rights policy supports this conclusion: "Unlike industry and many other universities, Stanford's invention rights policy allows all rights to remain with the inventor if possible." Stanford did not immediately gain title to the inventions.
Stanford v. Roche (Fed. Cir. 2009)
Federal Circuit o Was Holodniy's VCA with Cetus an automatic assignment? Language: "I will assign and do hereby assign to CETUS..." is a present assignment of Holodniy's future inventions. Cetus immediately gained equitable title to Holodniy's inventions. Cetus's equitable title converted to legal title when the parent application was filed on May 14, This negated Holodniy's subsequently executed assignment to Stanford (May 4, 1995) because Holodniy no longer retained any rights.
Stanford v. Roche (Fed. Cir. 2009)
Federal Circuit o Was Stanford a Bona Fide Purchaser (BFP) under 35 USC § 261? "An assignment, grant or conveyance shall be void as against any subsequent purchaser or mortgagee for a valuable consideration, without notice, unless it is recorded in the Patent and Trademark Office within three months from its date or prior to the date of such subsequent purchase or mortgage." 35 USC § 261 o Stanford was charged with notice of its employees' assignments (the VCA). o Stanford was not a BFP.
Stanford v. Roche (Fed. Cir. 2009)
Bayh-Dole Act- 35 USC § 200+ o US Government to take title under certain conditions. o The "contractor" universities or inventors can retain ownership if US Government does not. Stanford (and District Court): Bayh-Dole allowed Stanford a "right of second refusal" after Government refrained to exercise its rights. o Holodniy could only keep title if Stanford did not elect to retain title. Federal Circuit o Bayh-Dole does not void prior contractual transfers of rights. o Thus, Bayh-Dole did not automatically void the patent rights Cetus received from Holodniy.
Stanford v. Roche (Fed. Cir. 2009) Federal Circuit o Roche declaratory judgment of ownership barred by California's statutes of limitation. o Stanford lacks standing because it cannot establish ownership of Holodniy's interest.
Stanford v. Roche (Fed. Cir. 2009) Take Home Points: o Review the language in your assignments to make sure that it contains a present assignment of patent rights. "I do hereby assign" o When collaborating, make sure that employees do not sign anything unless it is reviewed.
Therasense v. Becton Dickinson (CAFC 2010) ' 551 Patent Allowed ' 551 Patent Membraneless Biosensor USPTO '382 Patent EPO Unrelated USPTO '636 Patent EPO Counterpart Anticipate/ Obvious Affidavit/Resp. '382 Patent Requires Membrane for Whole Blood Resp. in Revocation Proceeding Membrane is optional for Whole Blood Statements Never Cited to USPTO
Therasense v. Becton Dickinson (CAFC 2010) Federal Circuit- Failure to Cite EPO Statements was material- Inequitable Conduct –Applicants earlier statements about prior art, especially ones own prior art, are material to the PTO when those statements directly contradict the applicants position regarding that prior art in the PTO. 37 CFR 1.56(b)(2) In any event, the representations to the PTO were not merely lawyer argument; they were factual assertions…of those skilled in the art provided in affidavit form.
Therasense v. Becton Dickinson (CAFC 2010) Dissent (Judge Linn) – The question for purposes of materiality here is not whether Abbotts arguments to the PTO were meritorious (i.e., that the word preferably in the 382/636 patent would actually have been interpreted…to mean required); rather, the question is whether anything in Abbotts EPO submissions refutes, or is inconsistent with, its arguments to the PTO. Even if this information were material, however, the individuals who owed a duty of disclosure to the PTO produced a good faith explanation as to why they withheld the EPO submissions…Such an explanation will defeat a charge of inequitable conduct if it is plausible. The question, thus, is not whether it is plausible that the information is immaterial – a question asked under the objective materiality prong- but rather, whether it is plausible that the individuals subjectively believed that the reference was immaterial at the time they withheld it – a question presented under the subjective intent prong.
Therasense v. Becton Dickinson (CAFC 2010) New- Being reviewed en banc (April 26, 2010 order) Six questions to be briefed: 1. Should the materiality-intent-balancing framework for inequitable conduct be modified or replaced? 2. If so, how? In particular, should the standard be tied directly to fraud or unclean hands? [citations omitted] If so, what is the appropriate standard for fraud or unclean hands? 3. What is the proper standard for materiality? What role should the United States Patent and Trademark Offices rules play in defining materiality? Should a finding of materiality require that but for the alleged misconduct, one or more claims would not have issued?
Therasense v. Becton Dickinson (CAFC 2010) Six specific questions to be briefed: 4. Under what circumstances is it proper to infer intent from materiality? See Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) (en banc). 5. Should the balancing inquiry (balancing materiality and intent) be abandoned? 6. Whether the standards for materiality and intent in other federal agency contexts or at common law shed light on the appropriate standards to be applied in the patent context.
Indiana is Revising its Rules Regarding Attorney Advertising Not yet implemented Some Key Areas Clarifies the Specialty Language in Rule 7.4- e.g., Patent Attorney or Proctor in Admiralty Use of Trade Names with field of law, geographic location, and language proficiency will be allowed
Ethics- Old Rule 7.4 Communication of Specialty Practice When communication otherwise meets the requirements of Rules, 7.2, 7.3, and 7.5, a lawyer may: (a) communicate the fact that the lawyer does or does not practice in particular fields of law, but may not express or imply any particular expertise except as otherwise provided in Rule 7.4(b) (b) communicate that the lawyer is certified as a specialist in a field of practice when the certification and communication are authorized under Admission and Discipline Rule 30 [regarding Continuing Legal Education in Indiana]. (c) Notwithstanding subsection (b), a lawyer admitted to engage in patent practice before the United States Patent and Trademark Office may use the designation Patent Attorney or a substantially similar designation, and a lawyer engaged in Admiralty practice may use the designation Admiralty, Proctor in Admiralty or a substantially similar designation.
Ethics- New Rule 7.4 Communication of Specialty Practice (a) A lawyer may communicate that the lawyer does or does not practice in particular fields of law. (b) A lawyer admitted to engage in practice before the United States Patent and Trademark Office may use the designation Patent Attorney or a substantially similar, non-misleading, designation. (c) A lawyer engaged in Admiralty practice may use the designation Admiralty, Proctor in Admiralty or a substantially similar, non- misleading, designation. (d) A lawyer shall not state or imply that the lawyer is certified as a specialist in a particular field of law, unless: (1) The lawyer has been certified as a specialist by an Independent Certifying Organization accredited by the Indiana Commission for Continuing Legal Education pursuant to Admission and Discipline Rule 30 [regarding Continuing Legal Education in Indiana]; and, (2) The certifying organization is identified in the communication. (e) [ Indiana Commission for CLE vested with authority to accredit Independent Certifying Organizations mentioned in (d)(1) ]
Ethics- Old Rule 7.5 Professional Notices, Letterheads, Offices, and Law Lists (a) A lawyer or law firm shall not use or participate in the use of professional cards, professional announcement cards, office signs, letterheads, telephone directory listing, law lists, legal directory listings, or a similar professional notice or device if it includes a statement or claim that is false, fraudulent, misleading, deceptive, selflaudatory or unfair within the meaning of or that violates the regulations contained in Rule 7.2. (b) A lawyer shall not practice under a name that is misleading as to the identity, responsibility, or status of those practicing thereunder, or is otherwise false, fraudulent, misleading, deceptive, self-laudatory or unfair within the meaning of Rule 7.2, or is contrary to law. In that it is inherently misleading, a lawyer in private practice shall not practice under a trade name. However, the name of a professional corporation or professional association may contain P.C. or P.A or similar symbols indicating the nature of the organization, and if otherwise lawful a firm may use as, or continue to include in, its name, the name or names of one or more deceased or retired members of the firm or of a predecessor firm in a continuing line of succession.
Ethics- New Rule 7.5 Firm Names and Letterheads (a) A lawyer shall not use a firm name, letterhead or other professional designation that violates Rule 7.2. A trade name may be used by a lawyer in private practice if it does not imply a connection with a government agency or with a public or charitable legal services organization and if it is not otherwise in violation of Rule 7.2 Trade names are subject to the following requirements:... (3) Words that identify the field of law in which the firm concentrates its work, words that describe the geographic location of its offices, and words that indicate a language fluency may be used, so long as the firm name includes the name of a lawyer, or the name of a deceased or retired member of the firm, or of a predecessor firm in a continuing line of succession, as set forth in subparagraph (2) above.
Ethics- New Rule Comment:  A firm may be designated by the names of all or some of its members, or of deceased members where there has been a continuing succession in the firms identity. A trade name may also include words identifying the field of law in which the firm concentrates it work, the geographic location of its offices and words that indicate a language fluency. Examples would be De la Mirada Employment Law Firm of Greenwood written in Spanish, or Andersons Auto Accident Law, P.C., assuming that De la Mirada and Anderson are or have been members of these respective firms. A lawyer or law firm may also be designated by a distinctive website address or comparable professional designation. Although the United States Supreme Court has held that legislation may prohibit the use of trade names in professional practice, use of such [trade] names in law practice is acceptable so long as it is not misleading. If a private firm uses a trade name that includes a geographical location such as Springfield Legal Clinic, an express disclaimer that it is not a public legal aid agency may be required to avoid a misleading implication, furthermore the name of the firm must also include the name of at least one of its members or deceased members....
Ethics- New Rule Potential New Law Firm Name Under Proposed Rules: Doll and Schmal Patent and Trademark Law Firm of Indianapolis, LLP
Other Notable Cases Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. (Fed. Cir. 2010, en banc) Written Description and Enablement are Separate Requirements European Patent Office Rules Bilski- TBD
Want to know more? Chuck Schmal Patent Attorney Woodard, Emhardt, Moriarty, McNett & Henry LLP Chase Tower 111 Monument Circle, Suite 3700 Indianapolis, IN