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  • Conference & CLE Calendar

    CalendarSeptember 29, 2016 - IP & Diagnostics Symposium (Biotechnology Innovation Organization) – Alexandria, VA

    September 29, 2016 – "Patent Inventorship: Best Practices for Determination and Correction — Distinguishing Between Inventor and Contributor; Navigating Joint Inventorship, Disclosure of Ownership, and Real Party in Interest" (Strafford)

    September 29, 2016 – "Trade Secrets: Strategies for Understanding & Litigating a DTSA Cause of Action" (Wolters Kluwer) – 12:00 pm (ET)

    September 29, 2016 – "Second Medical Use Claims in South African Patent Law" (KISCH IP)

    September 29-30, 2016 – Advanced Patent Law Seminar (Chisum Patent Academy) – Washington, DC

    October 3-4, 2016 – Advanced Patent Law Seminar (Chisum Patent Academy) – Washington, DC

    October 13, 2016 – "Leveraging USPTO Examiner Count System: Efficiently Prosecuting Patents, Lowering Prosecution Costs" (Strafford) – 1:00 to 2:30 pm (EDT)

    October 19, 2016 – "To Patent or Not to Patent: When to Keep Your IP a Trade Secret" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

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

  • Webinar on Patent vs. Trade Secret Protection

    MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "To Patent or Not to Patent: When to Keep Your IP a Trade Secret" on October 19, 2016 from 10:00 am to 11:15 am (CT).  In this presentation, MBHB attorneys Grant Drutchas and Josh Rich will address key issues facing businesses and inventors in our post-AIA (America Invents Act) and DTSA (Defend Trade Secrets Act) world, and provide guidance on when you should consider maintaining technology as a trade secret rather than seeking patent protection.  Topics will include:

    • How best to approach the patent vs. trade secret issues, including the benefits and disadvantages of each form of protection;
    • When patent protection will best suit your business goals;
    • When it makes the most sense to maintain your IP as a trade secret;
    • What planning and precautions need to be in place to protect trade secrets;
    • The impact of the DTSA on your business, including the act's protections and obligations; and
    • How the courts have addressed the DTSA.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.

  • Webinar on Second Medical Use Claims in South Africa

    KischKISCH IP will be offering a webinar entitled "Second Medical Use Claims in South African Patent Law" on September 29, 2016.  The webinar, to be given by Ursula Baravalle, will provide a discussion of second medical use claims in South Africa and the positon of method of treatment claims and Swiss-type claims. The webinar will also include a discussion on the future transformation of South Africa's patent system from a depository system to a substantive examining system and the instruments that are currently in place to support South Africa's generic market whilst also respecting patented technology.  

    Additional information regarding the webinar can be found here.  Those wishing to register can do so here.

  • Webinar on Leveraging USPTO Examiner Count System

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Leveraging USPTO Examiner Count System: Efficiently Prosecuting Patents, Lowering Prosecution Costs" on October 13, 2016 from 1:00 to 2:30 pm (EDT).  Adriana L. Burgy, Kai Rajan, David C. Reese, and Stephanie Sanders of Finnegan Henderson Farabow Garrett & Dunner will provide guidance on leveraging the U.S. Patent & Trademark Office Examiner Count System to prosecute patents more effectively, and provide insight into the count system and offer strategies for interacting with patent examiners.  The webinar will review the following issues:

    • What impact will the number of claims in the application have on the quality of examination in the first office action?
    • How can patent counsel use the incentives of the count system to the client’s advantage?
    • How and when should patent counsel interact with examiners for effective and efficient prosecution?

    The registration fee for the webinar is $297.  Those interested in registering for the webinar, can do so here.

  • Yeda Research and Development Co. v. Abbott GmbH & Co. (Fed. Cir. 2016)

    By Kevin E. Noonan —

    YedaBefore the Supreme Court's recent forays into the topic of subject matter eligibility in patent law, the most contentious line of cases (from the Federal Circuit) concerned the written description requirement of Section 112.  Indeed, some (like former Chief Judge Rader) believed that the statute does not contain a separate written description requirement, an opinion firmly shut down by the Court's en banc decision in Ariad v. Eli Lilly & Co.  That case established not only the existence of a requirement separate from enablement that a specification provide an adequate written description, but affirmed the decision from Regents of the University of California v. Eli Lilly & Co. that the requirement was satisfied if the person of ordinary skill in the art would have understood the inventor to have possessed the invention throughout its full scope when the application was filed.

    Abbott AAlthough the principles seem to be settled (a dangerous assumption with this or perhaps any Supreme Court decision) the application of the law still leaves room for surprise.  One such surprise was enunciated by the Federal Circuit in its decision upholding a district court's finding that disclosure and possession can be satisfied inherently, in Yeda Research and Development Co. v. Abbott GmbH & Co.  The case came to the Court after two adverse decisions before the District Court (for the District of Columbia) and the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB).  Yeda and Abbott were in an interference involving Abbott's U.S. Patent No. 5,344,915 in which Yeda originally prevailed.  The basis for the initial PTAB decision was that the '915 patent was not entitled to an earlier priority date based on a German patent application.  Without that priority claim, it was undisputed that an intervening prior art reference (Engelmann) anticipated the claims.  The question was whether the original German patent, which disclosed isolation but not amino acid sequence characterization of a tumor necrosis factor binding protein, named TBP-II, inherently disclosed the amino acid sequence of the amino terminus, as recited in representative claim 1 of the '915 patent:

    A purified and isolated TNFα-binding protein which has a molecular weight of about 42,000 daltons and has at the N terminus the amino acid sequence
        Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Set Thr Cys Arg Leu Arg Glu
        where Xaa is hydrogen, a phenylalanine residue (Phe), or the amino acid sequences Ala Phe, Val Ala Phe, Gln Val Ala Phe, Ala Gln Val Ala Phe, Pro Ala Gln Val Ala Phe or Leu Pro Ala Gln Val Ala Phe.

    The disclosure of the priority applications was limited to "a partial N-terminus sequence, a protocol for obtaining the protein from its biological source, and additional properties of the protein, such as molecular weight, biological activity, and degradation characteristics when exposed to trypsin."  The parties also agreed, according to the Federal Circuit opinion, that the (partial) N-terminal amino acid sequence set out in the priority document(s) were only present in TBP-II, the same protein disclosed and claimed in the '915 patent.

    The PTAB found the '915 patent to be invalid for anticipation buy the Engelmann reference in original interference (No. 103,625) and Abbott brought suit in district court challenging that decision.  The District Court granted summary judgment for Abbott, agreeing that the priority application "inherently discloses the TBP-II protein and provides an adequate written description of the invention claimed in the '915 application" and remanded to the PTAB.  The PTAB found on remand that the '915 specification satisfied the written description requirement and Yeda filed its own district court action challenging that result.  Again, the District Court found that the '915 specification satisfied the written description requirement and granted summary judgment to Abbott.  This appeal followed.

    The Federal Circuit affirmed, in an opinion by Judge Reyna joined by Judges Wallach and Hughes.  Relevant to its decision, the panel noted that it was undisputed that the protein disclosed in the priority applications was the same protein disclosed in the '915 patent and in the Engelmann reference, and that this is the only protein having that amino acid sequence.  Under the doctrine of inherent disclosure," when a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention's inherent properties" according to the opinion, citing Kennecott Corp. v. Kyocera Int'l, Inc., 835 F.2d 1419, 1421 (Fed. Cir. 1987) (a pre-Ariad case now seeming to have the imprimatur of the Federal Circuit as remaining good law).  Here, under the circumstances of this case, the Federal Circuit held that the priority application inherently disclosed the N-terminal amino acid sequence of TBP-II.  Specifically, the Court said that "[i]t is not necessary for an application to disclose a protein's complete N-terminus sequence in order to provide an adequate written description of that protein."  In distinguishing this case from precedent cited by Yeda (Hyatt v. Boone, 146 F.3d 1348 (Fed. Cir. 1998) and In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004)), the importance of the circumstances is clear:  "[n]either Hyatt nor Wallach involved the situation present in this case, where it is undisputed that the invention described in an earlier application was the exact invention claimed by the later patent."

    The opinion also rejected Yeda's argument that inherent limitations cannot be relied upon in a priority determination if the limitations are material to patentability, citing Hitzeman v. Rutter, 243 F.3d 1345, 1355 (Fed. Cir. 2001).  Yeda supported its position that the specific amino acid sequences were material on the basis that Abbott had distinguished its claims from prior art "that disclosed a protein with the same source, weight, and function as the protein claimed in the '915 patent."  In the panel's view, the prosecution history did not corroborate Yeda's reading of the prior art disclosure, stating that "the cited art concerned only TBP-I, and that TBP-II includes a sequence of five amino acids not present in TBP-I that match the chain recited in the '915 patent claims."  And 3 of the 5 distinguishing amino acids disclosed in the Engelmann reference were also disclosed in the priority applications for the '915 patents and "were themselves sufficient to distinguish TBP-I from TBP-II."

    The apparent liberality applied by the Court in finding that the disclosure of the priority applications satisfied the written description requirement is in stark contrast to how stringently the requirement has been applied over the past twenty years in the USPTO, particularly in a variety of Guidances and Training Materials promulgated during that time.  But while certainly constrained by the particular facts set forth in the opinion, in some ways perhaps how the Court applied the requirement is consistent with Judge Lourie's formulation of how Section 112 should be interpreted in the Lilly case that in many ways was the beginning of modern written description jurisprudence:

    A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.

    Here, the "members of the genus" was in fact TBP-II itself, and the "structural features" comprised the partial amino acid sequence disclosed plus the protein itself from which the remaining amino acids comprising the N-terminus of the protein could be determined.  The situation here in many ways was the opposite of what Judge Lourie prescribed against:  not a broad genus defined purely by function, but a particular protein that inherently had an N-terminal amino acid sequence that need not be expressly recited in order to support a priority claim.

    Yeda Research and Development Co. v. Abbott GmbH & Co. (Fed. Cir. 2016)
    Panel: Circuit Judges Reyna, Wallach, and Hughes
    Opinion by Circuit Judge Reyna

  • Iron Gate Security, Inc. v. Lowe’s Companies, Inc. (S.D.N.Y. 2016)

    By Michael Borella —

    District Court for the Southern District of New YorkIron Gate, holder of U.S. Patent No. 7,203,693, sued Lowe's in the Southern District of New York, alleging infringement.  Lowe's moved to dismiss under Rule 12(b)(6), contending that the claims of the patent failed to meet the patent-eligibility requirements of 35 U.S.C. § 101.

    Claim 1 of the patent recites:

    A method for use in indexing, in a database, data associated with a domain-specific event, the method comprising the steps of:
        processing sensor data obtained in accordance with the event in real time, the sensor data comprising motion data of one or more objects or one or more people associated with the domain-specific event;
        obtaining pre-existing data associated with the domain specific event; and
        indexing data associated with the domain-specific event in the database, contemporaneous with capture of the data associated with the domain-specific event being indexed, based on at least a portion of the processed real time sensor data and at least a portion of the obtained pre-existing data, wherein the indexing step further comprises generating an index usable to retrieve at least a portion of the data associated with the domain-specific event by creating one or more cross-indexes between at least a portion of the processed real time sensor data and at least a portion of the obtained pre-existing data.

    According to the patent, "none of the existing multimedia data indexing techniques permit indexing to be accomplished substantially concurrently or contemporaneously with the capture of the multimedia data."  The claimed invention "introduces a new paradigm of converting a real world event in real time into a rich multimedia database by processing data from multiple sensors observing the event."  This results in purported improvements of "(i) immersion in a virtual environment where the viewer can choose to view any part of the event from any desired viewpoint at any desired speed; (ii) the ability to visualize statistics and implicit information that is hidden in media data; (iii) the ability to search for, retrieve, compare and analyze content including video sequences, virtual replays and a variety of new visualizations; and (iv) the ability to access this information in real time over diverse networks."  In an illustrative example, the patent describes video capture of a tennis match, through which sensor and pre-existing data may include "match-set-game hierarchy data, camera parameter data, player and tournament information, baseline, service line, net information, score / winner / ace information, and 3D environment models."

    In Alice Corp. v. CLS Bank, the Supreme Court stated that compliance with § 101 requires use of a two-prong test.  First, one must first determine whether the claim at hand is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then one must further 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.  But generic computer implementation of an otherwise abstract process does not qualify as "significantly more."  A goal of this test is to prevent one from patenting one of the judicial exclusions, and thereby preempting others from using this basic scientific tool.

    Lowe's contended that the invention was directed to the unpatentable abstract idea of "organizing data using an index so that newly obtained data can be associated with pre-existing data for purposes of subsequent retrieval."  According to Lowe's, such activity could be performed mentally, the claim did not include anything in addition to this concept other than generic computer components, and the invention did not improve over the prior art.

    Iron Gate rebutted by arguing that the patent involves "a specific methodology for real-time retrieval of data by processing motion data from a sensor in real time, indexing data from the sensor contemporaneously with its capture based on the processed real-time sensor data and pre-existing data, and generating an index by cross-indexing based on that data."  This, according to Iron Gate, was an improvement to data access and storage technology, and provides a solution to the problem of real-time retrieval of multimedia data.

    In discussing the Alice test, the Court distinguished between the eligibility requirements of § 101 and the novelty requirements of § 102.  Particularly, "that a true invention may not be novel is a question for § 102, not § 101," and that the judicial exclusions to patent-eligibility are "not intended to preclude protection for a genuine invention that teaches an improvement and is directed to solving a particular problem, even if the invention invokes or builds upon, for example, an abstract idea."

    Reviewing prong one, the Court interpreted the main thrust behind Alice and its progeny as "determin[ing] whether the claim moves beyond a long-understood concept or simply seeks to monopolize one by masking it through the medium of technology."  To do this, a court must ask "whether the claims are directed to a specific implementation to a solution to a problem."  Importantly, "[t]he point is not to deem ineligible any task or concept that can possibly be envisioned or performed by the human mind."

    With respect to prong two, the Court stated that "the objective is to determine whether the claims provide a solution to a problem; it is not intended to replace the requirements for validity (e.g., utility, novelty, nonobviousness)."  Synthesizing the case law, the Court produced a list of questions relevant to the prong two inquiry:

    (1) Is there an improvement recited?
    (2) Is there a benefit recited?
    (3) Is something new recited?
    (4) Does the patent have one or more particular applications?
    (5) What are the steps and limits to be followed in applying the invention?

    Applying Alice, the Court found that Lowe's high-level description of the claims mischaracterized the invention therein.  According to the Court, Lowe's would "require the Court to read Alice in a way that essentially swallows all of patent law," which is not the objective of prong one.  Referring to the recent Enfish v. Microsoft decision, the Court noted that "a court should not construe a patent at too high a level of generality, nor should it broadly find all improvements in computer-related technology to be directed to abstract ideas."  Doing so would leave little opportunity for any claim to be patent-eligible.

    Particular elements of claim 1, such as "the limitations of processing motion data from a sensor in real time, indexing data from the sensor at the same time as its capture along with pre-existing data, and generating an index by cross-indexing the real-time data against the pre-existing data" led the Court to conclude that the patent is directed to "particular improvements over prior art multimedia data indexing techniques that render such data accessible in real time."  In the Court's view, this resulted in the invention being designed to solve a problem that exists within the technological realm, rather than just implement the abstract idea of indexing data.

    Further, the Court found that the patent was not directed to "the addition of conventional computer components to well-known business practices, computer implementation of a mathematical formula, generalized steps (existing outside of the realm of computers) to be performed through conventional computer activity, or other concepts that can be formulated and implemented entirely within the human mind."  Notably, the Court refused to make any factual findings regarding whether the claimed invention could be performed in the human mind at this early stage of the proceedings, but it left open the possibility that Lowe's could bring this challenge again at a later date.

    In addressing prong two, the Court reprimanded Lowe's for "asking the Court to compare the '693 Patent to prior art in the field of multimedia data indexing."  The Court declined to take this approach, noting that it "must accept the specification's assertions—at least with respect to the claimed invention's advantages over prior art—to be true on their face."  Further, even if "a patent claim adds little to prior art . . . does not mean that the claim lacks an inventive concept vis-à-vis an abstract idea."

    The Court also discussed the similarities between the prong one and prong two analyses post-Enfish.  Observing that "it is easier to separate the two steps in recitation than in application and that the two steps could arguably be collapsed into a single one," the Court found that "many of the same aspects that support the determination that the '693 Patent is not directed to an abstract idea at Alice step one also support the conclusion that, even if it were so directed, the claims nonetheless contain an inventive concept."  Thus, the claims were determined to be patent-eligible, and Lowe's motion was denied.

    With the rapidly evolving § 101 landscape, it is often difficult to determine whether a District Court's reasoning will be influential on other courts.  Here, the discussion of mental activities is in line with the recent Federal Circuit McRo v. Bandai decision (therein the inquiry was deemed to be not whether a claimed process can be carried out mentally, but whether it has been carried out mentally), and therefore is likely a sign of things to come.  Additionally, the Court is interpreting Enfish as requiring, when at the pleadings stage, that courts take as given any purported improvements that a patent's specification set forth.  As a consequence, including an elucidation of such improvements in a specification (as is now common practice) may effectively short circuit § 101 challenges in a motion to dismiss.  However, the door remains open for the challenger to dispute such assertions during and after discovery.

  • LifeNet Health v. LifeCell Corp. (Fed. Cir. 2016)

    By Kevin E. Noonan —

    USPTO SealThe complexities that can be attendant on defending against an infringement allegation, and the possibility that a straightforward path to non-infringement can be complicated by claim construction even for terms construed using their plain meaning, are illustrated in the Federal Circuit's opinion affirming a jury verdict of infringement in LifeNet Health v. LifeCell Corp.

    The suit involved LifeNet's ("Net") allegation that LifeCell's ("Cell") sales of "[p]lasticized soft tissue grafts for transplant" for "medical, orthopedic, dental, and cosmetic surgery applications" infringed its U.S. Patent No. 6,569,200.  These grafts provide an alternative to freeze drying the tissue for transplantation (which was conventional art practice); instead, the water in the tissue is replaced with "biocompatible plasticizers" including, inter alia, glycerol.  Using the claimed grafts avoids rehydration from a freeze-dried state that raised problems in the art.

    Claim 1 of the '200 patent is representative:

    1.  A plasticized soft tissue graft suitable for transplantation into a human, comprising:
        a cleaned soft tissue graft having an internal matrix; and
        one or more plasticizers contained in said internal matrix;
        said one or more plasticizers are not removed from said internal matrix of said plasticized soft tissue graft prior to transplantation into a human.

    Relevant to the Court's decision, the italicized limitation in the claim was added during prosecution to overcome prior art (Cavallaro reference, U.S. Patent No. 5,718,012) that disclosed using plasticizers to strengthen collagen threads but required that the plasticizer be removed before use.

    The specification of the '200 patent states that while the glycerol or other plasticizer can be removed prior to implantation the removal step isn't required.  The physician has options:

    (1) "direct implantation of the grafts without further processing following removal from the packaging";

    (2) "implantation following a brief washing in sterile isotonic saline to remove any remaining traces of plasticizer associated with the immediate surfaces of the grafts"; or

    (3) "implantation following an extended (approximately 1 hour) washing with sterile isotonic saline to remove as much plasticizer as possible."

    Cell's accused infringing soft tissue grafts were preserved in a plasticizer ("Solution E") wherein the graft was soaked in saline for at least 2 minutes prior to use, a treatment that removes "significant amounts" of the plasticizers.

    The District Court's claim construction was directed to the limitation (added during prosecution) that the plasticizers were "not removed" from the graft prior to use.  Net argued that some, but not all, of the plasticizer could be removed, while Cell argued that none of the plasticizer could be removed if infringement would lie.  According to the opinion, Cell argued that the term required that "no processing steps are taken, before transplantation into a human that result in any amount of the one or more plasticizers being taken out of the internal matrix of the plasticized soft tissue graft," while Net argued that the term meant the grafts were used "without complete replacement of the plasticizer or plasticizers in the internal matrix of the tissue graft prior to direct implantation into a human."  The District Court construed the claim using the plain meaning of the term, that "not removed" means 'no plasticizers are removed prior to transplantation.'"  To a jury, Cell presented evidence that "as much as 50% of the plasticizer in [its] products is removed during the [] saline rinse" in arguing its products did not infringe.  Net countered that the graft comprises an internal matrix from which the plasticizer is not removed by Cell's rinse (as required by the claim and based on expert testimony) and thus the limitation is met and Cell's accused articles infringed.  A jury decided that Cell infringed the asserted claims of the '200 patent, found Cell had not established its invalidity defenses, and awarded Net almost $34 million.  Cell appealed.

    The Federal Circuit affirmed, in an opinion by Chief Judge Prost, joined by Judges Reyna and Chen.  Cell presented five arguments on appeal:  1) the jury (rather than the court) improperly resolved a dispute regarding the meaning of "not removed" in the claim; 2) no matter how the term is construed, Cell cannot be liable for direct infringement, because it is the physician or technician that prepares a graft for transplantation, not the company; 3) the claims are indefinite for reciting a "method of use" limitation in a claim to an apparatus, citing IPXL Holdings, LLC v. Amazon.com, Inc., 430 F.3d 1377 (Fed. Cir. 2005); 4) the District Court misconstrued the term "plasticized soft tissue graft" which, if properly construed, renders its products non-infringing; and 5) the claims are anticipated by U.S. Patent No. 4,357,274 or obvious over this reference and the knowledge of one having ordinary skill in the art.

    Cell's claim construction argument regarding the meaning of the term "not removed" was that the legal dispute about the term's meaning was wrongly presented to the jury (insofar as the jury was required to determine the plain meaning of this term), citing O2 Micro International Ltd. v. Beyond Innovation Technology Co., 521 F.3d 1351 (Fed. Cir. 2008).  The Federal Circuit held that Cell had not requested further construction at trial and thus had not properly raised an O2 Micro issue.  The panel recognized that this term related to two types of removal:  how much of the plasticizer was removed, and from where it was removed (i.e., the "degree" of removal versus the locus of removal at the "internal matrix" of the tissue).  The opinion further recognized that Cell's argument on appeal was that the internal matrix was the same as the tissue graft, so that removal of the plasticizer from the "gaps and voids" of the tissue was the same as removal from the internal matrix.  Unfortunately for Cell, the Federal Circuit found that Cell did not "timely request modification of the district court's claim construction" and, moreover, argued throughout that the issue was one of fact rather than being a claim construction question.  On the merits, the Court noted (in a footnote) that the term was properly construed according to its plain meaning in light of disclosure in the specification, including that the graft could be briefly rinsed or washed for one hour prior to transplantation; presumably, these treatments also resulted in no removal of the plasticizer from the internal matrix.  Finally, on this issue the Court rejected Cell's attacks on Net's experts' trial testimony and particularly purported contradictions contained therein.  Accordingly, the Court held that there was substantial evidence supporting the jury's finding of infringement.

    On the question of divided infringement or inducement of infringement, the panel held that "the non-removal limitation clarifies that the recited plasticizer has not been removed and, because the plasticizer is biocompatible, can remain in the internal matrix of the tissue graft during transplantation, i.e., it need not ever be removed."  As a limitation related to characterizing properties of the graft, rather than reciting a method step, the practice of this element required no action by a third party, and the Court affirmed the jury's finding of literal infringement liability on this basis (and the District Court's refusal to grant JMOL).

    With regard to the IPXL issue (that it is improper for a claim to recite "method of use" limitations in a claim to an apparatus), the Court's determination regarding the non-removal limitation on the divided infringement question (that it recited a property of the tissue graft and not an affirmative limitation regarding steps to remove the plasticizer from the graft) was dispositive:  under this reading of challenged claims 1-4 there was no mixing of apparatus and method claims and thus the claims were not indefinite.

    Cell's challenge to the District Court's construction of the term "plasticized soft tissue graft" was based on its assertion that in addition to interpreting the term to mean that the "water of hydration" in the tissue had been replaced by the plasticizer, the Court should have required that the graft was "'dehydrated' in the sense that the tissue can only have 'low residual moisture.'"  The Federal Circuit agreed with Net's position that the term "dehydration" "merely means that some of the water has been replaced with plasticizer," consistent with the District Court's construction and based on specific disclosure in the specification.

    Finally with regard to Cell's invalidity arguments, the panel found substantial evidence supporting the jury's finding that the '274 patent did not anticipate the '200 patent's claims.  Specifically, based on conflicting expert testimony, the Court was persuaded that while the '200 patent disclosed methods for avoiding "significantly altering" the mechanical properties of the tissue graft, the methods disclosed in the '274 patent resulted in significant alternation of the mechanical properties of the tissue.  "The ultimate issue on this record was a classic factual dispute that the jury was free to resolve in LifeNet's favor," according to the opinion, citing Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1361 (Fed. Cir. 2012).  Cell's obviousness arguments were similarly unpersuasive and the Federal Circuit upheld the District Court's denial of JMOL or a new trial on this issue.

    LifeNet Health v. LifeCell Corp. (Fed. Cir. 2016)
    Panel: Chief Judge Prost and Circuit Judges Reyna and Chen
    Opinion by Chief Judge Prost

  • Zak v. Facebook, Inc. (E.D. Mich. 2016)

    Software Patent Found to Be Directed to Abstract Idea, But Survives § 101 Challenge with Inventive Concept

    By Joseph Herndon —

    E.D. MichBruce Zak, an individual, sued Facebook, Inc. for patent infringement in the U.S. District Court for the Eastern District of Michigan on two of his software patents — United States Patent Nos. 8,713,134 and 9,141,720.  Facebook moved for summary judgment arguing that the subject matter of the two patents is not eligible for patent protection under § 101.  The District Court denied Facebook's motion for summary judgment even though the representative claim was found to be directed to an abstract idea, since the claim was further found to recite enough details to specify how a solution will be implemented that addresses a business challenge particular to the Internet.

    In the early 2000s, Plaintiff, a computer programmer, started a company called Everyware, Inc. that was focused primarily on a new software product called 7Ware.  The purpose of 7Ware was to allow users to maintain a dynamic website by giving users the ability to manage the content of a website without having to depend on a person skilled in HTML computer programming.  During creation of the software to enable users to post content without third party assistance, Plaintiff realized that the software would be more useful if users could control which other users could view content on the website and which other users could post content on certain web pages.  In order to achieve these functions, Plaintiff developed software that generated user-configurable links based upon user-configurable business rules to control the functionality of web pages with respect to permission to view and/or post certain content.

    Plaintiff filed a patent application for the invention from which the two patents in suit were granted.  The patents teach a system that permits users to input characteristics into configurable applications generated by the computer and to act as administrators for different sets of web pages within the same website.  The claims of these patents are directed to enabling users, without third-party assistance, to post content to a website and to control which users can view the posted content.  Claim 2 of the '720 patent is representative of the patent eligibility analysis, and is reproduced below.

    2.  A system, including a computer and a web site, for managing content displayable on the web site to multiple users of the system who have profiles stored on the system, comprising:
        at least a first configurable application and a second configurable application, wherein each of the first and second configurable applications includes content that is stored on the computer and that is displayable to the users of the web site, and wherein one of the applications is a biography application that is managed by the computer and that displays biographical information that is received from and that is about one of the users of the system;
        wherein at least one of the configurable applications is generated by the computer at least in part based on inputs received from multiple users of the system, the inputs including at least one of text, graphics, sounds, documents, and multi-media content;
        an administrator portal through which users of the system are permitted to act in the role of an administrator of certain web pages, wherein a user acting in the role of an administrator may manage business rules that utilize profiles of the users of the system to control interaction of the users with the certain web pages, wherein each user of the system is permitted to act in the role of an administrator at least with respect to a subset of web pages on the web site; and
        at least one configurable link on the web site that points to at least one of the plurality of configurable applications,
        wherein the at least one configurable link is generated by the computer based at least in part on a profile attributed to at least one user of the system and at least one rule that is configurable by a user acting in the role of an administrator and which applies user profiles to select what content stored on the computer can be viewed by which of the users of the system.

    The '720 patent describes its invention as providing non-technical users control over the content of a website without the need for more technical personnel to assist and as also providing users the ability to create, modify, or delete content automatically.  The claimed invention allows users to customize not only who can view the content but also who can post content.  In these systems, users have stored profiles that consist of at least a first configurable application and a second configurable application, one of which is a biography application.

    To summarize the '720 patent, the users of the system create profiles containing biographical information, and the user can control the interaction other users have with her web page by altering business rules that utilize the biographical information from other users' profiles.  The system receives a request to view and/or post content to a website and uses the configured rule to determine whether the user can view or post content.

    Defendant claims that the patents relate to "techniques for group collaboration and targeted communication," and are not patent-eligible because the claim is directed to abstract ideas with no inventive concept.

    The District Court followed the two step test for determining patent-eligibility.  Step one of the Mayo/Alice test "determin[es] whether the computer-implemented claims at issue here are 'directed to' a patent-ineligible abstract idea."  If the court concludes at step one that the claims are directed to an abstract idea, the court must then ask at step two whether the elements of each claim, both individually and "as an ordered combination," include an inventive concept such that it transforms the nature of the claim into a patent-eligible application.

    1.  Evaluating Claims Under Step One

    The District Court noted that determining whether a patent's claims are "directed" to an abstract idea can be difficult because the Supreme Court and the Federal Circuit have not defined precisely what an abstract idea entails.  The following categories have been recognized by either the Supreme Court or the Federal Circuit as abstract ideas: (1) something that could "be performed in the human mind, or by a human using a pen and paper," (2) "fundamental economic practices long prevalent," (3) methods of organizing human activity, or (4) mathematical formulas.  Courts also look to whether the representative claim is directed to the improvement of the functioning of the computer itself.

    Claim 2 is directed to allowing non-technical individuals to control who is able to (1) post content and (2) view content on a number of websites.  In applying step one of the Mayo/Alice test, the District Court looked to whether claim 2 is directed to the improvement of the functioning of the computer itself rather than to an abstract idea.  The claim in the present case, in consideration of its limitations, does not unambiguously purport to increase speed, improve storage, or improve functionality of the computer itself.

    Plaintiff argued that the claim improves the functioning of the computer due to the user-configured business rules and configurable/application links.  However, the District Court found that the claim language of the patent does not clearly state how these features improve the functioning of the computer itself.  The claims describe a method to manage and control posting content and viewing content; they do not suggest that a computer's functioning would be improved, but rather that a user's ability to harness that functionality would be improved.  Since the claim language is less than completely clear, the District Court could not conclude with any certainty that the claim and its limitations improve the functioning of the computer itself.

    The District Court determined that Plaintiff's patents are directed to group collaboration with targeted communication and restricting public access, which — like filtering data in the BASCOM case — are arguably methods of organizing human behavior.  Consequently, the Court concluded that the representative claim of the '134 and '720 patents is directed to the abstract idea of organizing human behavior and does not clearly improve the functioning of a computer.

    2.  Evaluating Claims Under Step Two

    If the claims at issue do not improve the function of a computer itself but instead are directed to a patent-ineligible abstract idea, courts look to step two of the Mayo/Alice test.  Step two of the Mayo/Alice test searches for an "inventive concept," which is "an element or combination of elements that is 'sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.'"

    The District Court likened the present claims to those in BASCOM, where the Federal Circuit explained that some inventions' basic thrust might more easily be understood as directed to an abstract idea, but under step two of the Alice analysis, it might become clear that the specific improvements in the recited computer technology go beyond well-understood, routine, conventional activities and render the invention patent-eligible.

    The District Court found that claim 2 in this case specifies how the websites may be manipulated to achieve a desired result.  Representative claim 2 states that the system stores profiles from multiple users.  The users input text, graphics, sounds, and more to create at least one configurable application that displays biographical information about the users.  Each user can act as an administrator to manage business rules that permit the user to control the interaction of other users with his or her web page(s), creating a configurable link.  The link will utilize user profiles to determine what content can be viewed by which users.

    In the present case, the claim does not merely permit a known business practice to be performed on the Internet.  Instead, the claim here specifies how a solution will be implemented that addresses a business challenge particular to the Internet, namely allowing ordinary users to maintain dynamic websites by managing the content of websites and controlling users' interactions with web pages.

    The District Court further supported this decision by indicating that, similar to the claims in BASCOM, although the limitations to the claim in this case are not inventive alone, the ordered combination of these limitations is inventive because, taken together, the limitations are not routine and conventional.  The claim does not simply dictate that communication must be targeted and access restricted.  Instead, the claim states that users themselves will be able to control interactions on their web pages by managing business rules that will utilize profiles of other users to generate configurable links to determine how other users may interact with his or her web page.  The claim and its limitations recite a specific, discrete implementation of the abstract idea.

    Thus, the District Court found that this claim includes a sufficiently inventive concept to allow the conclusion that the patent is not directed to an ineligible subject matter under the Mayo/Alice test.

    The District Court summarized that regardless of whether the subject matter of the patent is characterized as group collaboration with targeted communication or as restrictions on public access, the claim contains enough inventive elements to be aimed at more than a patent on the abstract idea itself.

    As seen here, the District Court relied heavily on comparing the disputed claims to those of prior cases to develop support for the ultimate decision of patent-eligible subject matter.  Claim 2 was found to be sufficiently directed to a specific application of group collaboration, in contrast to being directed to group collaboration generically.  The Federal Circuit has helped the patent owner with the Enfish, BASCOM, and recently decided McRO cases, which together provide the patent owner with a greater chance to survive a § 101 challenge.  Successful comparison of disputed claims to those in any of these three Federal Circuit cases will provide the patent owner with the best chances to survive the § 101 challenge. 

    Zak v. Facebook, Inc. (E.D. Mich. 2016)
    Opinion and Order Denying Defendant's Motion for Summary Judgment by Judge Terrence G. Berg

  • FDA Approves Release of Genetically Engineered Mosquitoes

    By Donald Zuhn –-

    FDALost among reports of the first locally transmitted cases of the Zika virus in the continental United States in late July (as well as concern over Zika transmission at the 2016 Summer Olympics in Rio de Janeiro, Brazil in August), was an announcement last month regarding the U.S. Food and Drug Administration's completion of an environmental review for a proposed field trial of genetically engineered mosquitoes.  The field study will be conducted to determine whether the release of genetically engineered (GE) mosquitoes made by Oxitec Ltd., a British biotechnology company that develops genetically modified insects to assist in insect control, will suppress the local Aedes aegypti mosquito population in the release area at Key Haven, Florida.  The GE mosquitoes carry a self-limiting gene, so when male GE mosquitoes are released into the wild and mate with wild females, their offspring inherit the self-limiting trait.  The resulting offspring will die before reaching adulthood, and the local mosquito population will decline.

    The FDA noted that after considering thousands of public comments submitted in response to the agency's draft environmental impact study, the FDA was able to publish a final environmental assessment, entitled "Environmental Assessment for Investigational Use of Aedes aegypti OX513A," and "Finding of No Significant Impact".  The FDA indicated that the latter report agrees with environmental assessment that the proposed field trial will not have significant impacts on the environment.

    In making the announcement, the FDA also noted that the release of the environmental assessment and report of no significant impact did not mean that Oxitec's GE mosquitos are approved for commercial use.  Instead, Oxitec will still be responsible for ensuring that all other local, state, and federal requirements are met before conducting the proposed field trial.  Oxitec is partnering with the Florida Keys Mosquito Control District in conducting the proposed field trial.

    As of last week, the Centers for Disease Control and Prevention reports that there have been 43 cases of locally acquired mosquito-borne Zika virus in the United States and 17,629 cases of locally acquired mosquito-borne Zika virus in U.S. territories.  All of the U.S. cases to date have been in Florida.

  • Webinar on Federal Circuit Trends in a Post-Alice World

    CPA GlobalCPA Global will offer a one-hour webinar entitled "Federal Circuit Trends in a Post-Alice World" on September 20, 2016 from 1:00 to 2:00 pm (ET).  Gene Quinn of IPWatchdog, Inc., and Robert Schaffer and Joseph Robinson of Troutman Sanders will discuss recent patent eligibility cases in the Federal Circuit that have come down in favor of eligibility, giving a glimpse into the future of patent eligibility in a post-Alice world.

    Those interested in registering for the webinar can do so here.