Tag: USPTO

USPTO Freedom Of Information Act Inquiry

Whats Next, Question Marks, Freedom of Information Act, FOIAThe Freedom of Information Act (“FOIA”) can be a very powerful tool. It provides unqualified right to access certain public records. Patent attorney Gary Shuster used it to file a FOIA request (Request No. F-17-00099) with the USPTO on January 26, 2017, seeking the following:

1. Any document written by or on behalf of Michelle Lee constituting a resignation from office, a request to withdraw a resignation from office, or a request to refrain from her position.

2. The most current document identifying the Director of the USPTO or, if there is no director, the acting director of the USPTO.

3. Any written instructions received between January 20, 2017 and the date of this request regarding deletion of any data from web sites operated by or on behalf of the USPTO, including USPTO.com.

To spare the USPTO having to compile and produce all documents responsive to this request, Shuster offered: “In the alternative, you may satisfy this request by simply answering the following question: Who is the current director or acting director of the USPTO?”

On February 24, 2017, USPTO FOIA specialist Karon Seldon sent Shuster a letter stating that the agency was extending the time limit, citing FOIA provisions allowing extensions in “unusual circumstances.” This is a FOIA provision which provides an extension may be claimed in usual circumstances where there is a “need for consultation … with another Federal Agency having a substantial interest in the determination of the request.” This is likely to give a bit of breathing room to determine how the Trump administration will affect the decision.

The new deadline for response is March 10, 2017. Although it’s currently a bit of a mystery, we’ll see tomorrow who will be named to the Director role.

ARTICLE BY Annie Dike of IMS ExpertServices

© Copyright 2002-2017 IMS ExpertServices, All Rights Reserved.

Ariosa v. Sequenom: In Search of Yes After a Decade of No

The Federal Circuit this Wednesday declined to reconsider its June decision in Ariosa v. Sequenom, a closely watched medical diagnostics case involving patents on cell-free fetal DNA testing. Biotech companies, investors, and patent lawyers alike should expect a prompt petition for certiorari, and should hope that the Supreme Court grants it.  (Disclosure: I was one of twenty-three law professors who submitted an amicus brief urging the Federal Circuit to grant en banc rehearing.)

In the last decade, the Supreme Court has suggested in case after case that the inventions they were considering were not merely unworthy of patent protection because they were, say, not inventive enough or useful enough or disclosed in enough detail. Rather, the Court in these cases gave us information about the very boundaries of the patent system—by placing the disputed inventions outside those boundaries altogether. But they have not yet told us what is just inside those boundaries.

This legal uncertainty has a significant chilling effect on investment in innovation, one that we are increasingly able to quantify.  As USPTO Chief Economist Alan Marco and I explained in a 2013 paper in the Yale Journal of Law and Technology, when a court issues a decision resolving the legal uncertainty over whether a patent was valid, that newfound certainty actually moves the market as much as the initial patent grant does.  In other words, the unpredictability of courts forces the market to discount—by as much as half—how much trust to put in the legal rights that the Patent Office issues.

Patent holder Sequenom certainly experienced the downside of that uncertainty, as Wednesday’s rehearing denial sent its stock price tumbling over 14% in just two days.  Others have taken a hit as well, such as the large-cap DNA analysis firm Illumina, which has pursued Ariosa in a separate patent litigation and whose stock price fell 7% across the same two-day period.

The reason for this uncertainty is that we are effectively back in the late 1970s, when the Court was prominently rejecting inventions as patent-ineligible subject matter—Gottschalk v. Benson in 1972 and Parker v. Flook in 1978—without saying anything concrete about what was eligible.  Relief would come only after Diamond v. Chakrabarty in 1980 and Diamond v. Diehr in 1981, when the Court finally produced binding precedents going the other way.

The result is that today’s patentees can only try to run away from the settlement risk mitigation patent in Alice Corp. v. CLS Bank (2014), the breast cancer genetic diagnostic patent in AMP v. Myriad (2013), the thiopurine dosage monitoring patent in Mayo v. Prometheus (2012), the energy futures risk hedging patent application in Bilski v. Kappos (2010), and, although they were never definitively adjudicated, the vitamin deficiency diagnostic patents in LabCorp v. Metabolite (2006).  There is no case yet to run toward.

Ariosa v. Sequenom could have been that case and still can be, if the Court grants certiorari.  Certainly the Federal Circuit order has framed the issue well.  The per curiam order denying en banc rehearing was accompanied by three opinions that addressed in different combinations both the reach and the wisdom of the Supreme Court’s recent precedents.

Judge Dyk’s concurrence concluded that the precedents, particularly Mayo and Alice, do apply to the present facts and that those precedents are generally sound.  He invited “further illumination” from the Supreme Court only on whether the all-important inventive concept must come at the second step of the two-step Mayo test (application of the natural law or abstract idea) or may also come at the first step (discovery of the natural law).  Meanwhile, Judge Newman’s dissent concluded that the precedents, particularly Mayo and Myriad, do not apply here, for the facts “diverge significantly.”  She found the Sequenom patent’s subject matter to be eligible and would have proceeded to more specific patentability analysis under §§ 102, 103, 112, etc.

Their midpoint and the best argument for certiorari was Judge Lourie’s concurrence, which agreed that Mayo controls, with “no principled basis to distinguish this case from Mayo”—but which also urged that Mayo and the Supreme Court’s other precedents from Bilski onward are an increasingly unsound basis for differentiating between natural laws and abstract ideas on the one hand, and applications of those laws and ideas on the other hand.  Echoing a previously expressed position of the Patent Office, he favored the “finer filter of § 112” for issues of indefiniteness or undue breadth (rather than what the agency’s post-Bilski Subject Matter Eligibility Guidelines called the “coarse filter” of § 101).

He also pushed back directly against a argument that the Supreme Court frequently invokes to express its preference for flexible standards that foster over predictable rules that can be manipulated: the draftsman’s art.  Decisions from Flook and Diehr to Mayo and Alice have rested in part on the suspicion that patent lawyers may at any time evade substantive doctrinal limitations through clever claim drafting.  To this Judge Lourie’s opinion aptly responded that “a process, composition of matter, article of manufacture, and machine are different implementations of ideas, and differentiating among them in claim drafting is a laudable professional skill, not necessarily a devious device for avoiding prohibitions.”

In these regards, Judge Lourie’s approach may well represent the “center” of the Federal Circuit on subject-matter eligibility.  He was in the en banc majority in Bilski and authored the panel opinion in Mayo.  He authored both panel majority opinions in Myriad (before and after the Supreme Court’s GVR order).  And he authored the five-judge en banc plurality opinion in Alice, whose analysis was ultimately consolidated and endorsed in the Supreme Court’s opinion in that case.

With the issues so well framed and the recent subject-matter eligibility precedents so well synthesized, then, there is reason to be optimistic that a decade of hearing “no” from the Supreme Court may finally give way to a “yes” and better orient us on the true boundaries of our patent system.

Article By Saurabh Vishnubhakat of Texas A&M University School of Law

© Copyright 2015 Texas A&M University School of Law

New Amendments to USPTO Post-Grant Regulations

OUS-PatentTrademarkOffice-Sealn May 19, 2015, the United States Patent and Trademark Office (USPTO) issued a final rule amending its regulations that apply to post-grant proceedings. These new rules deal with ministerial changes such as increasing page limits and making the regulations reflect the current practices used by the Patent Trial and Appeal Board (PTAB).

A second set of rule changes—to be issued later this year—will be more substantive and issued in proposed form first with an opportunity for public comment. We will issue an On the Subject when the second set of rules is issued, and we will be happy to assist with the submission of any comments. Below is a brief overview of the major provisions of this first amendment to the regulations.

  • Motions to Amend. The page limit for motions to amend, and oppositions to motions to amend, is increased from 15 pages to 25 pages. The required claim listing may now be made in an appendix accompanying the motion to amend, and the appendix is not counted toward the 25-page limit.

  • Petitioner’s Reply Brief. The page limit for the petitioner’s reply to patent owner’s response after institution is increased from 15 pages to 25 pages.

  • Font Style. All filings must be in 14-point, Times New Roman proportional font.

  • Back-Up Counsel. The rules are modified to make it clear that there can be more than one back-up counsel. There may be only one lead counsel.

  • Fees. The rules clarify that you must include in the number of claims in the petition when calculating the required fees each challenged claim as well as any claim from which a challenged claim depends, unless that claim is separately challenged. The USPTO explains that the claims from which the dependent claim depends must be construed along with the dependent claim.

  • Right to Depose. The rules make clear that routine or automatic discovery only includes affidavit testimony prepared for the post-grant proceeding. Consequently, if an affidavit is submitted from a district court proceeding, a motion must be filed to depose that affiant.

  • Objections to Evidence. The rule makes it clear that objections to evidence must be filed with the PTAB and served on opposing counsel.

  • Covered Business Method Proceedings. The rule explicitly provides that a covered business method proceeding may not be instituted where the petitioner filed a civil action challenging the validity of a claim of the patent before filing the petition. The change was made to track the statute.

ARTICLE BY Bernard Knight & Carey C. Jordan of McDermott Will & Emery
© 2015 McDermott Will & Emery

Understanding Post-AIA Power of Attorney Procedures –America Invents Act

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Applicants identified upon a U.S. patent application’s filing can impact the ownership rights to the patent application throughout prosecution.  Prior to implementation of relevant aspects of the America Invents Act (AIA) on September 16, 2012, patent application Applicants could only be Inventors.  Conversely, applications filed on or after September 16, 2012 can have Inventors or Assignees as Applicants.  The choice of Applicant – Inventors or Assignees – upon filing in post-AIA applications affects how Power of Attorney can be properly established before the U.S. Patent and Trademark Office (USPTO).

Pre-AIA patent applications filed before September 16, 2012 can have Power of Attorney granted by Inventors or Assignees under Rule 32, provided that the requirements of Rule 3.73 are satisfied.  In contrast, post-AIA applications filed on or after September 16, 2012 can be filed with Inventors or Assignees as the Applicant, with Rule 32 requiring a Power of Attorney to be signed by either the “Applicant” or “Patent Owner.”  However, an Assignee only becomes the patent owner after the application issues as a patent.  Thus, in order to take over prosecution in a post-AIA application, the Assignee must either initially be listed as or later formally established to be the Applicant for Power of Attorney to be granted on behalf of the Assignee.

In circumstances where a post-AIA application’s Applicant is identified upon filing as the Assignee, the Assignee may execute a Power of Attorney, and it can be filed without the need to file any separate papers to satisfy Rule 3.71 or Rule 3.73.

When a post-AIA patent application is filed without listing the Assignee as the Applicant (i.e., because the Inventors are listed as the Applicant) or when the Assignee changes during the course of prosecution, Rule 3.71 or Rule 3.73 must be satisfied for the Assignee to establish a Power of Attorney before the USPTO.  Namely, a statement under Rule 3.73(c) and a Power of Attorney must be filed.  However, the Assignee must first be identified as an Applicant.  Currently there are two ways for an Assignee to become an Applicant when not so listed upon initial application filing.  First, an Applicant can be added to the existing list of Applicants.  Alternately, all Inventors can be removed as the Applicant and be replaced with the Assignee as the Applicant.

A change in an Applicant can be accomplished by filing a supplemental Application Data Sheet (ADS), fulfilling the Rule 3.73(c) requirements including a showing of ownership.  A chain of title can be demonstrated through executed assignment(s) and a statement specifying where documents verifying the chain of title from the original owner to the assignee are recorded in the assignment records of the USPTO by reel and frame number.  After adding the Applicant, Rule 3.71 or Rule 3.73 can be satisfied by filing a statement under Rule 3.73(c) and filing a properly executed Power of Attorney, thereby appointing the designated patent practitioner.

Accordingly, administrative burdens on the USPTO, on Assignees, and on Assignee representatives can generally be reduced by filing post-AIA applications listing the Assignee as the Applicant, should the Assignee be known at the time of filing.

Colleen Witherell also contributed content for this article.

ARTICLE BY

Christina Sperry
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

The USPTO’s New Guidance Simplifies Prosecution by Clarifying Subject-Matter Eligibility of Patents

Armstrong Teasdale Law firm

The U.S. Patent and Trademark Office (PTO) issued new guidance on Dec. 8, 2015 that provides improved clarity to those prosecuting patent applications in the computer-implemented and biochemical arts. Although many questions remain on the issue of subject matter eligibility, this guidance will be a useful tool to move prosecution of such applications past rejections under 35 U.S.C. § 101. It is available here.

The Interim Guidance on Patent Subject Matter Eligibility (the “Guidance”) will be available to examiners for prosecution immediately. This long-awaited document aims to provide better clarity on the subject matter eligibility of computer-implemented patents and patents in the biological, chemical and biochemical arts. For the past several months, navigating the eligibility of such patent applications has been difficult, in part due to unclear PTO rules and procedures following the Supreme Court decisions of Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) and Mayo Collaborative Serv. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).

The Guidance primarily focuses on adding details to the two-step subject matter eligibility test of Alice Corp. and Mayo. The first step of this test is to “determine whether the claim is directed to a law of nature, a natural phenomenon, or an abstract idea.” Here, the Guidance affirms the PTO’s broad power to find claims pending before the office as being directed to such judicially created exceptions.

Although the Guidance provides several examples of abstract ideas and natural phenomenon, it is clear that these examples are non-limiting. As such, the Guidance confirms the substantial discretion that has been used by examiners, courts and the Patent Trial and Appeal Board (PTAB) to find that claims are directed to abstract ideas or laws of nature. In light of this broad discretion, applicants should avoid only arguing that their claims are not directed to such exceptions. Such arguments will likely fail, therefore applicants should not rely solely on this approach.

The second step is to “determine whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception.” The Guidance provides applicants with new methods of showing “significantly more” than previously provided.

First, the Guidance re-affirms the validity of the “machine or transformation” test. Specifically, “applying the judicial exception with, or by use of, a particular machine” and “effecting a transformation or reduction of a particular article to a different state or thing” both can constitute “significantly more” than the abstract idea, law of nature or natural phenomenon. Second, the Guidance states that “adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application” may also constitute “significantly more”.  This language appears to give PTO examiners significant latitude to overcome rejections under 35 U.S.C. § 101.

The Guidance also clarifies that “extrasolution activity” and “linking the use of the judicial exception to a particular technological environment or field of use” will not constitute “significantly more”, resolving an open question since Alice Corp. It also specifies that when a claim recites “a plurality of exceptions,” failing to find “significantly more” for any one of those exceptions will cause the claim to fail subject matter eligibility.

Additionally, the Guidance provides a new option for applicants with claims that “clearly do not seek to tie up any judicial exception such that others cannot practice it.” Though the meaning of this statement is unclear, the PTO has offered an option of “streamlined eligibility analysis” for such claims.

There are some notable limitations to the Guidance. First, the Guidance does not constitute substantive rulemaking and lacks the force of law. As a result, examiners are not formally required to follow it. (Practically, however, we anticipate it will be used by most examiners.) Second, the Guidance is not binding on or applicable to litigation proceedings or proceedings at the Patent Trial and Appeal Board (PTAB). Third, these are truly “interim” guidelines.

We anticipate that final rules and laws are still in development and this area of law will continue to change over the coming months. More information on the Interim Guidance can be found here.

© Copyright 2014 Armstrong Teasdale LLP. All rights reserved

Post Holiday Trademark Sale!!!!!!!

Giordano Halleran Ciesla Logo

The USPTO announced that they are having a sale.  You can save $50 per class on all new trademark registration applications and $100 on all renewals.  The Final Rule issued on December 16, 2014 announced that trademark filing fees will be reduced.

Small Print:  Unfortunately, the discounts will not be effective in time for the holidays.  The new discounted fees don’t kick in until January 17, 2015.  In the good news department, the discounts will continue thereafter!

ARTICLE BY

Kurt E. Anderson
OF
Giordano, Halleran & Ciesla, P.C.

USPTO Issues New Subject Matter Eligibility Examination Interim Guidelines – Abstract Idea Guidance

Sterne Kessler Goldstein Fox

On December 15, 2014, the USPTO issued Interim Guidance for examination of subject matter eligibility under 35 U.S.C. § 101. These new guidelines largely follow the previous interim guidelines issued on June 25, 2014, in view of CLS v. Alice (2014), with some additional details. The new guidelines have also combined that earlier guidance for claims reciting abstract ideas with the March 4, 2014, guidance for claims reciting natural phenomena/laws of nature.

Under the new guidelines, the examiner will first determine whether the claim is directed to one of the four accepted statutory categories. If it does, examiners are instructed to apply the 2-part patent-eligibility analysis, as articulated by the Supreme Court in Alice. Examiners are instructed to apply the 2-part analysis to the broadest reasonable interpretation of the claims when analyzed as a whole. Importantly, the Guidance also confirms that “[e]very claim must be examined individually, based on the particular elements recited therein, and should not be judged to automatically stand or fall with similar claims in an application.”

Analysis for Software/Business Method Claims – Abstract Idea Guidance

To evaluate software and business method claims, the “abstract idea” analysis laid out in the Guidance will be the most relevant. To determine whether a claim recites an abstract idea, the 2-part Alice test is as follows: 1) determine whether the claims are directed to an abstract idea, and if they are, then 2) determine whether the claims recite additional elements that amount to significantly more than the abstract idea.

Part 1

In accordance with Alice, the Interim Guidance notes that fundamental economic practices, certain methods of organizing human activities, an idea ‘of itself,’ and mathematical relationships/ formulas are recognized as abstract ideas. Citing previous cases, the Interim Guidance provides examiners with specific examples of abstract ideas:

  • mitigating settlement risk (Alice);

  • hedging (Bilski);

  • creating a contractual relationship (buySAFE);

  • using advertising as an exchange of currency (Ultramercial);

  • processing information through a clearinghouse (Dealertrack);

  • comparing new and stored information and using rules to identify options (SmartGene);

  • using categories to organize, store and transmit information (Cyberfone);

  • organizing information through mathematical correlations (Digitech);

  • managing a game of bingo (Planet Bingo);

  • the Arrhenius equation for calculating the cure time of rubber (Diehr);

  • a formula for updating alarm limits (Flook);

  • a mathematical formula relating to standing wave phenomena (Mackay Radio); and

  • a mathematical procedure for converting one form of numerical representation to another

    (Benson).

Part 2

If no abstract idea is found in Part 1, then Part 2 need not be addressed. But if Part 1 identifies an abstract idea in the claims, Part 2 is considered. The Guidance stresses the importance of considering the claim as a whole, rather than addressing individual elements on their own.

The Guidance provides examples of limitations that may be enough to qualify as “significantly more” when recited in a claim. These examples include:

  • improvements to another technology or technical field;

  • improvements to the functioning of the computer itself;

  • applying the abstract idea with, or by use of, a particular machine;

  • effecting a transformation or reduction of a particular article to a different state or thing;

    • adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; and

    • other meaningful limitations beyond generally linking the use of the abstract idea to a particular technological environment.

      These examples are consistent with the recent Federal Circuit Decision in DDR Holdings, LLC. v. Hotels.com (DDR).

      Limitations that do not qualify as “significantly more” include:

    • adding the words “apply it” (or an equivalent) with the abstract idea, or mere instructions to implement an abstract idea on a computer;

    • simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the abstract idea, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry;

    • adding insignificant extrasolution activity to the abstract idea, e.g., mere data gathering in conjunction with the abstract idea; and

    • generally linking the use of the abstract idea to a particular technological environment or field of use.

      2-Part Analysis Not Always Necessary

      According to the Interim Guidance, examiners do not need to perform the complete 2-part analysis when eligibility is self-evident. A full analysis may not be needed where the claims clearly do not preempt the abstract idea in such a manner that others cannot practice it. For instance, the interim guidelines note that a claim directed to a complex manufactured industrial product or process that recites meaningful limitations along with an abstract idea may sufficiently limit its practical application so that a full eligibility analysis is not needed. As an example, a robotic arm assembly having a control system that operates using certain mathematical relationships is not an attempt to tie up use of the mathematical relationships and would not require the examiner to perform the full 2-part analysis to determine eligibility.

    The Interim Guidance is effective on December 16, 2014 and is not legally binding. The USPTO is seeking public comments on this Interim Guidance along with additional suggestions on claim examples by March 15, 2015.

Federal Circuit’s Sandoz Decision Increases Importance of Post-Grant Proceedings to Biosimilar Developers

Sterne Kessler Goldstein Fox

On Friday, December 5, the U.S. Court of Appeals for the Federal Circuit rendered its decision in Sandoz v. Amgen, No. 2014-1693, a case with major implications for the emerging U.S. biosimilars industry. The decision addresses when and how a party seeking to launch a biosimilar product in the U.S. can initiate litigation to challenge the brand company’s potential blocking patents. This is the first instance in which the Federal Circuit has had the opportunity to address the scope and applicability of the Biologics Price Competition and Innovation Act (BPCIA), which established a formal pathway for biosimilar approval in the US.

Background

At issue in Sandoz is a litigation Sandoz, Inc. initiated against Amgen, Inc. and Hoffman-La Roche Inc. on June 24, 2013. Sandoz’s complaint seeks a declaratory judgment (DJ) that two patents owned by Roche and exclusively licensed to Amgen are invalid, unenforceable, and would not be infringed by the commercial marketing of Sandoz’s biosimilar version of Amgen’s blockbuster biologic product Enbrel® (etanercept). The patents at issue extend Amgen’s protection around etanercept an additional 15 years past the original patents. Sandoz filed its complaint against Amgen prior to filing any application with the FDA for approval to market its biosimilar etanercept product, which is currently in Phase III clinical trials. Sandoz will not file with the FDA until the Phase III trial is complete, and of course will not be able to market its version of etanercept in the US without FDA approval. At the time of suit, Amgen had not alleged Sandoz was currently doing anything that exposes it to liability for infringing Amgen’s patents rights around Enbrel®.

The District Court Decision

Amgen moved to dismiss Sandoz’s complaint, asserting that the court lacked jurisdiction to hear the case because no immediate and real controversy between the parties exists. In a brief order, the court granted Amgen’s motion to dismiss on two separate grounds. First, the court ruled that its discretion to enter a DJ in the case is subject to the provisions of the BPCIA, which sets specific limitations on the timing and conduct of any litigation arising from the filing of an application for approval to market a biosimilar. The court concluded that “neither a reference product sponsor, such as Amgen, nor [a biosimilar applicant] such as Sandoz, may file a lawsuit unless and until they have engaged in a series of statutorily–mandated exchanges of information” related to patents potentially in dispute. In this case, Sandoz had not complied with the exchanges as it had not even started the process by filing its application with the FDA.

Second, the court found that Sandoz had not established jurisdiction under traditional grounds because it had not established a real and immediate injury or threat of future injury caused by Amgen. The court noted that Amgen had never advised Sandoz that it intended to sue Sandoz, and that the mere allegation by Sandoz that it intended to file an application for FDA approval in the future was not sufficient to create a case on controversy. Sandoz appealed the district court order dismissing the action.

The Federal Circuit Decision

On appeal, Sandoz argued that the litigation provisions of the BPCIA only govern the statutory patent infringement litigation authorized by the Act after a biosimilar application is filed with the FDA, and do not apply to DJ actions in general. Sandoz further argued that nothing in the BPCIA can be construed to bar or limit in any way the ability to bring DJ actions to resolve patent disputes prior to filing a biosimilar application. Finally, Sandoz argued that the district court erred in concluding that Sandoz had not adequately demonstrated a sufficient actual case or controversy sufficient to allow the DJ action to proceed.

The Federal Circuit panel affirmed the district court’s dismissal of Sandoz’s complaint, concluding that Sandoz had not alleged an injury of sufficient immediacy and reality to create subject matter jurisdiction. The Federal Circuit noted that “a case of actual controversy” is a prerequisite to exercising declaratory judgment jurisdiction. The test for determining whether a case or controversy exists is whether “ there is a substantial controversy . . . of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.” The Federal Circuit, however, declined to address the lower court’s interpretation of the BPCIA as barring a lawsuit by either the reference product sponsor or the biosimilar applicant unless and until the parties have engaged in the statutorily-mandated patent information exchanges.

In concluding that Sandoz’s complaint does not present a case or controversy, the Federal Circuit panel noted that there was no prior decision in which the Federal Circuit had found a case or controversy to exist when the only activity that would create exposure to potential infringement liability was a future activity requiring FDA approval that had not yet been sought. The court found the immediacy requirement lacking where the conclusion of Sandoz’s Phase III trial, which was a prerequisite for filing for FDA approval, was still several years away when Sandoz filed suit. The court refused to assume that the Phase III trial would be successful, and noted that the trial could in fact uncover issues with Sandoz’s product that could push the application filing date back even further. Alternatively, the clinical trial could fail resulting in Sandoz never seeking FDA approval, or Sandoz could modify its proposed product and file for approval on the modified product. The court also noted that Sandoz’s complaint lacked specificity as to how Amgen’s patents read or don’t read on Sandoz’s product; and instead relies on prior general assertions by Amgen that the patents at issue cover Enbrel, that Amgen will assert the patents against products that compete with Enbrel, and that Sandoz intends to market a competing product at some point in the future. Ultimately, the court concluded that the events allegedly exposing Sandoz to infringement liability may not occur as anticipated or may not occur at all. The court found that Sandoz also had not shown that it would suffer any “immediate and substantial adverse impact” from not being able to seek or secure a patent adjudication before filing its application for FDA approval.

Unanswered Questions

The Federal Circuit specifically stated that its decision was limited to the particular facts before it, and does not address whether Sandoz would be able to seek declaratory judgment jurisdiction once it files its FDA application, or whether the BPCIA forecloses declaratory judgment actions outside of the statutorily-mandated patent information exchange once the application is accepted by the FDA. The decision also did not clarify the additional issue disputed by the parties concerning what constitutes sufficient “notice of commercial marketing,” which the BPCIA states must be provided by the biosimilar applicant prior to launch.

Increased Important of Post-Grant Proceedings before the USPTO

Although the Sandoz court made a point to limit the scope of its decision to the facts before it, the decision casts substantial doubt on the ability of any biosimilar developer to bring a district court action challenging the reference product sponsor’s patents prior to filing a biosimilar application with the FDA and triggering the patent information exchange provisions of the BPCIA. At the same time, the decision elevates the importance to biosimilar developers of post-grant challenges before the U.S. Patent and Trademark Office, such as inter partes review (IPR) and post-grant review (PGR), as means for obtaining some degree of early patent certainty before initiating the FDA approval process. IPRs in particular have proven to be a potent weapon for generic drug manufacturers in the context of ANDA litigation. The lower standard of proof required to show invalidity, the expedited pace of the proceedings, and the decreased cost in comparison to district court litigation coupled with the extremely high rate in which patent claims are being invalidated provide generic manufacturers with tremendous leverage to obtain favorable settlements with brand companies. We expect that the Sandoz decision should only increase the speed with which post-grant proceedings are adopted in the biosimilar arena.

ARTICLE BY

Timothy J. Shea, Jr., PhD.
Paul A. Calvo
OF
Sterne, Kessler, Goldstein & Fox P.L.L.C.

They Know It When They See It: Patentable Subject Matter After Alice

VedderPriceLogo

To those with even a casual interest in the preparation and prosecution of patents in the United States, the holding in the Supreme Court’s June 2014 decision in Alice Corp. v. CLS Bank International is well known: claims directed to intermediated settlement encompass an abstract idea, and generic recitation of a computer implementation in such claims fails to transform the abstract idea into patent-eligible subject matter. Predictably, numerous articles have since been published extolling the virtues (or lack thereof, as the case may be) of theAlice decision. While the patent eligibility debate is good and necessary, it leaves open the question of many would-be patentees: may I get a patent on my software-based innovation?

While the Court provided virtually no “bright line” rules in answer to this question, the decision nevertheless suggests various approaches that may be employed going forward to best ensure your patent application embraces patent-eligible subject matter.

Background

Alice Corporation obtained various patents directed to, as the Court put it, “a computerized scheme for mitigating ‘settlement risk’—i.e., the risk that only one party to an agreed-upon financial exchange will satisfy its obligation.” In a highly fractured opinion, the Court of Appeals for the Federal Circuit concluded that all of Alice’s claims were directed to patent-ineligible subject matter.

On further appeal, the Court cited its recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., in which the Court laid out its two-step process for separating patents directed to patent ineligible concepts from “those that claim patent-eligible applications of those concepts.” First, one must “determine whether the claims at issue are directed to . . . patent ineligible concepts.” If so, in the second step, one must then ask what else is in the claims that may be sufficient to “transform” the ineligible concept into a patent-eligible application thereof.

Unfortunately, the Court provides no guidance how one goes about determining whether claims are directed to ineligible concepts in the first step. In fact, the Court expressly takes a pass on the issue, stating that it “need not labor to delimit the precise contours” of what constitutes a patent-ineligible concept. Instead, the Court noted that it’s Bilski decision concerned claims directed to “hedging,” which “all members of the Court agreed” constituted an abstract idea. Without further reference to the actual language of the claims, the Court stated that Alice’s “claims . . . are drawn to the concept of intermediated settlement.” With this setup, the Court quickly concluded that “[l]ike the risk hedging in Bilski, the concept of intermediated settlement is a ‘fundamental economic practice long prevalent in our system of commerce.'”

Turning to the second step, the Court had little trouble in determining that various other recitations in the claim beyond the abstract idea failed to “do more than simply instruct the practitioner to implement the abstract idea of intermediated settlement on a generic computer.” Looking at “the claim elements separately,” the Court stated that “each step does no more than require a generic computer to perform generic computer functions.” Further, considering the claimed computer elements “as an ordered combination” did not add anything “that is not already present when the steps are considered separately.”

Going Forward

So, you are now considering patent protection for your new, software-implemented invention, but the Court’s “guidance” in Alice has left you unsure whether it makes sense to proceed. Despite the outcome in Alice, patents based on software-implemented innovations have not been knocked out entirely, though they did take a pretty good punch to the gut. Going forward, would-be patentees must take greater care to ensure that they claim and present their inventions in a manner that minimizes the likelihood of being interpreted as an “abstract idea.” The following observations should help you avoid that pitfall.

1. Stay As Far Away From Bilski and Alice As You Can

As noted, the closest the Court came to providing concrete guidance for identifying patent-ineligible abstract ideas was to measure how close the underlying “inventive concept” of an invention comes to the abstract ideas found in Bilski and, in the future, Alice. That is, if the subject matter of your claims is reasonably analogous to the risk hedging claimed in Bilski or the intermediated settlement in Alice, it’s almost certainly going to be viewed as embracing an abstract idea. Instead, try to find a way to describe the subject matter of your invention as something other than a concept that is related to these concepts.

Even more so than before, for software-implemented ideas, application drafting will require a careful balancing of what you say in the specification and in the claims. That is, the difference between whatever abstract idea is arguably discussed in the specification versus the limitations in your claims (∆abst) should be as large as possible.

For example, assume an invention concerns a new technique for completing payments for goods and services via mobile, wireless devices, which method facilitates a more rapid exchange of certain types of data. Having a method claim that begins “A method for completing payments via mobile, wireless devices” strongly suggests that the “inventive concept” is directed to the mere idea of completing financial transactions, which starts to sound awfully similar to the intermediated settlement of Alice. Rather than focusing the claim on the novelty of the financial transaction itself, attempt to focus the claim on the effect the method has on the underlying mobile device, e.g., “A method for communicating transactional data by a mobile, wireless device.”

2. Get “Technical”

Perhaps more importantly, even if you can strongly contrast your claims to the underlying abstract idea, you may still be on shaky grounds if your application doesn’t somehow discuss how it leads to a technological improvement. In Alice, when rejecting the sufficiency of a generic computer implementation to rescue claims otherwise directed to an abstract idea, the Court specifically noted that the claim did not “purport to improve the functioning of the computer itself . . . [or] effect an improvement in any other technology or technical field.” Stated another way, rather than directing your specification and claims as teaching improvements to a traditionally human-implemented field of endeavor (e.g., hedging risk, mediating settlement risk), they should clearly establish how the innovation improves the operation of a machine (i.e., the computer implementing the software-driven method) or an overarching “technology or technical field” in which the computer-implemented method is employed.

The graph below illustrates the apparent “sliding scale” nature of the abstract idea and technology aspects of the Alice decision. As shown, the connection of the claimed subject matter to improvement to a particular technology is shown along one axis, and the distinction of the claims over an encompassed abstract idea (∆abst) is shown along the other. For claimed subject matter that demonstrates little distinction from the alleged abstract idea and that demonstrates a weak connection to a technological improvement, there is little likelihood (“No Chance”) of demonstrating subject-matter eligibility. Oppositely, for claimed subject matter that is strongly distinguished from the alleged abstract idea and that clearly concerns a technological improvement, there is a much greater likelihood (“No Problem”) of demonstrating subject-matter eligibility. It is to be expected, however, that the relative areas of the illustrated outcomes will be different according to the particular realm of abstract ideas at hand, i.e., the “No Chance” area is likely to be much larger when dealing with finance-related inventions versus inventions concerning, say, telecommunications.

 

For example, assume an invention concerns a new process applicable to trading platforms for various financial instruments, e.g., stocks, commodities, etc. Where possible, one should not stress how the claimed process makes trading markets more efficient or enables different types of financial instruments to be traded. Instead, it may be better to acknowledge in the specification that electronic trading is well-known and that the invention leads to better operation of the underlying machines (e.g., where the claimed process enables the machine to complete more trades per unit of time, complete the trades more accurately, in a manner less consuming of resources, etc.) or broadens the capabilities of such machines (e.g., where the process provides a function that was previously unavailable). In drafting the specification, carefully ascribe certain steps to humans versus machines where possible and then make sure the claims don’t include any of the human-performed steps.

3. Get to Know a European Patent Attorney

It has been observed by many commentators that the Alice decision is yet another nudge of U.S. practice in the direction of European practice, i.e., focused on a “technical problem” for which your invention must provide a “technical solution.” European patent attorneys have been dealing with such issues for many years and may be able to offer valuable insights how to best position your invention in an application.

4. Be Prepared to Make Decision Makers Prove “Abstractness”

A concern with the Court’s lack of guidance when assessing whether a claim embraces excluded subject matter is that, not unlike those seeking to obtain patents, the examiners at the U.S. Patent & Trademark Office (USPTO) and federal district court judges will be equally in the dark. Unfettered from concrete guidance, it may be anticipated that examiners and judges will be more apt to make unsubstantiated assertions that claims encompass abstract ideas. Having drafted your claims and specification as noted above, i.e., emphasizing less how the invention helps achieve a business goal or perform human tasks better and instead illustrating how it improves/extends operation of an underlying machine or overarching technology, you will at least have a stronger foundation for arguing against the alleged abstract idea.

ARTICLE BY

Christopher P. Moreno
OF
Vedder Price

PTO Litigation Center Report – April 11, 2014

Sterne Kessler Goldstein Fox

Listed below are all new filings before PTAB of requests for inter partes review (IPR) and covered business methods review (CBM).  Also listed are any newly-posted requests for ex parte reexamination at the USPTO.  This listing is current as of 9:45 AM on Friday, April 11, 2014.

New IPR Requests

Trial Number – IPR2014-00604
Filing Date – 4/10/2014
Patent # – 6,896,775
Title – HIGH-POWER PULSED MAGNETICALLY ENHANCED PLASMA PROCESSING
Assignee –  ZOND, INC.
Petitioner – THE GILLETTE COMPANY
Status – Pending
Tech Center – 1700

Trial Number – IPR2014-00605
Filing Date – 4/10/2014
Patent # – 7,348,723
Title – EMISSION DEVICE, SURFACE LIGHT SOURCE DEVICE, DISPLAY AND LIGHT FLUX CONTROL MEMBER
Assignee –  ENPLAS CORPORATION
Petitioner – Seoul Semiconductor Co., Ltd.
Status – Pending
Tech Center – 2800

Trial Number – IPR2014-00606
Filing Date – 4/10/2014
Patent # – 6,833,404
Title – HOT MELTS UTILIZING A HIGH GLASS TRANSITION TEMPERATURE SUBSTANTIALLY ALIPHATIC TACKIFYING RESIN
Assignee –  H.B. FULLER COMPANY
Petitioner – HENKEL CORPORATION
Status – Pending
Tech Center – 1700

Trial Number – IPR2014-00607
Filing Date – 4/10/2014
Patent # – 7,870,249
Title – NETWORKED SYSTEM FOR INTERACTIVE COMMUNICATION AND REMOTE MONITORING OF INDIVIDUALS
Assignee –  ROBERT BOSCH HEALTHCARE SYSTEMS, INC.
Petitioner – Medtronic, Inc.
Status – Pending
Tech Center – 2400

Trial Number – IPR2014-00610
Filing Date – 4/10/2014
Patent # – 7,490,151
Title – ESTABLISHMENT OF A SECURE COMMUNICATION LINK BASED ON A DOMAIN NAME SERVICE (DNS) REQUEST
Assignee –  VIRNETX INC.
Petitioner – Microsoft Corporation
Status – Pending
Tech Center – 2100

New CBM Review Requests

Trial Number – CBM2014-00115
Filing Date – 4/10/2014
Patent # – 7,970,674
Title – AUTOMATICALLY DETERMINING A CURRENT VALUE FOR A REAL ESTATE PROPERTY, SUCH AS A HOME, THAT IS TAILORED TO INPUT FROM A HUMAN USER, SUCH AS ITS OWNER
Assignee –  ZILLOW, INC.
Petitioner – TRULIA, INC.
Status – Pending
Tech Center – 3600

Newly-Posted Reexam Requests

Control # – 90/013,207
Date – 4/10/2014
Patent # – 7,489,423
Inventor –  Nachman, Marvin J. et al.
Assignee –  INFINITY COMPUTER PRODUCTS, INC.
Title – INTERFACE CIRCUIT FOR UTILIZING A FACSIMILE MACHINE COUPLED TO A PC AS A SCANNER OR PRINTER
Co-pending Litigation – Infinity Computer Products, Inc. v. Toshiba America Business Solutions, Inc., No. 2:12-cv-06796-LDD (E.D. Pa.) and 11 other litigations.

Control # – 90/013,208
Date – 4/10/2014
Patent # – 6,894,811
Inventor –  Nachman, Bruce G. et al.
Assignee –  INFINITY COMPUTER PRODUCTS, INC.
Title – INTERFACE CIRCUIT FOR UTILIZING A FACSIMILE COUPLED TO A PC AS A SCANNER OR PRINTER
Co-pending Litigation – Infinity Computer Products, Inc. v. Toshiba America Business Solutions, Inc., No. 2:12-cv-06796-LDD (E.D. Pa.) and 11 other litigations.

Control # – 90/013,209
Date – 4/10/2014
Patent # – 8,040,574
Inventor –  Nachman, Bruce G. et al.
Assignee –  INFINITY COMPUTER PRODUCTS, INC.
Title – INTERFACE CIRCUIT FOR UTILIZING A FACSIMILE MACHINE TO A PC AS A SCANNER OR PRINTER
Co-pending Litigation – Infinity Computer Products, Inc. v. Toshiba America Business Solutions, Inc., No. 2:12-cv-06796-LDD (E.D. Pa.) and 11 other litigations.

Control # – 90/013,210
Date – 4/10/2014
Patent # – 8,294,915
Inventor –  Nachman, Bruce G. et al.
Assignee –  INFINITY COMPUTER PRODUCTS, INC.
Title – INTERFACE CIRCUIT FOR UTILIZING A FACSIMILE MACHINE COUPLED TO A PC AS A SCANNER OR PRINTER
Co-pending Litigation – Infinity Computer Products, Inc. v. Toshiba America Business Solutions, Inc., No. 2:12-cv-06796-LDD (E.D. Pa.) and 11 other litigations.

Article By:

PTO Litigation Center
Of:
Sterne, Kessler, Goldstein & Fox P.L.L.C.