Patent Docs

Washington College of Law Post-Argument Discussion of SAS Institute Inc. v. Matal

November 18, 2017

As part of its ongoing Supreme Court series, the American University Washington College of Law Program on Information Justice & Intellectual Property will be hosting a post-argument discussion on the SAS Institute Inc. v. Matal case beginning at 4:00 pm (Eastern) on November 27, 2017 at the American University Washington College of Law in Washington, DC. The panel will include Counsel for Respondent Matthew Topic of Loevy & Loevy. The Federal Circuit Bar Association is co-sponsoring the panel discussion.

Additional information about the post-argument discussion, including registration/CLE information, can be found here.
Biotech Institute’s Growing Patent Portfolio — U.S. Patent No. 9,095,554 and the Path Forward

November 16, 2017

By Nicole Grimm, Brett Scott, and George "Trey" Lyons, III —

As with any billion dollar market, patents are an important consideration for the cannabis industry. Despite its current classification as a Schedule I drug under the Controlled Substances Act, however, the U.S. Patent and Trademark Office has issued hundreds of patents on cannabis to date. These patents cover a range of cannabis-related inventions, including methods of treatment with cannabinoids, cannabis-infused edible products, cannabis consumption methods and devices, and methods of growing Cannabis plants. Even the Cannabis plant itself is fair game for patenting via both utility and plant patents.[1]

However, one family of utility patents, in particular, entitled "Breeding, Production, Processing, and Use of Specialty Cannabis" (collectively, the "Biotech cannabis patents"), has many in the cannabis industry concerned. This patent family is owned by Biotech Institute LLC of Westlake, California, and provides, according to the abstract: "compositions and methods for the breeding, production, processing and use of specialty cannabis." The over-250-page specification (as filed) contains 43 examples directed to a host of embodiments including:

• chemical analysis of cannabinoids and terpenes of the Cannabis plants described in the specification (Examples 1, 7, 13, and 17);
• parental classes of Cannabis varieties (Example 2);
• Cannabis varieties with high THC content or non-THC content and terpene profiles to meet specific aroma/flavor or medicinal needs (Examples 3 and 4);
• breeding programs (Example 5);
• strains producing both THC and CBD or CBD alone (Example 6);
• tracking the Cannabis plants during production, processing, and use (Example 21);
• feedback-based cultivation systems (Example 23);
• packaging single-dose units in a bubble pack (Example 25);
• use as a vaporized expectorant (Example 26);
• use of specialty cannabis in edibles (Example 29);
• use of multiplexed cannabis mixtures to treat brachial plexus avulsion, arthritis, motion sickness, seizures, neuropathic pain, depression, irritable bowel syndrome, pain from cancer, psychosis-related diseases (g., schizophrenia) as well as to aid in weight loss and improve cholesterol levels (Examples 31-41); and
• zero-point delivery devices and doses (Examples 42 and 43).

Although the specification contains extensive tables showing cannabinoid and terpene profiles of the Cannabis varieties described in the specification, as well as actual data from volunteer trials using the Cannabis plants, many of the examples are prophetic and aspirational.

Claiming priority to U.S. provisional applications that were filed on March 15, 2013, and October 29, 2013, this family currently contains three granted U.S. patents and two pending continuation applications. The first patent in this family was granted as U.S. Patent No. 9,095,554 ("the '554 patent") on August 4, 2015.

Claim 1 of the '554 patent recites:

1. A hybrid cannabis plant, or an asexual clone of said hybrid cannabis plant, or a plant part, tissue, or cell thereof, which produces a female inflorescence, said inflorescence comprising:
    a) a B_T/B_Dgenotype;
    b) a terpene profile in which myrcene is not the dominant terpene;
    c) a terpene oil content greater than about 1.0% by weight; and
    d) a CBD content greater than 3%;
    wherein the terpene profile is defined as terpinolene, alpha phelladrene, beta ocimene, careen, limonene, gamma terpinene, alpha pinene, alpha terpinene, beta pinene, fenchol, camphene, alpha terpineol, alpha humulene, beta caryophyllene, linalool, cary oxide, and myrcene, and wherein the terpene oil content is determined by the additive content of the terpenes in the terpene profile; and wherein the terpene contents and CBD content are measured by gas chromatography-flame ionization detection (GC-FID) and calculated based on dry weight of the inflorescence; wherein a representative sample of seed producing said plants has been deposited under NCIMB Nos. 42246, 42247, 42248, 42249, 42250, and 42254.

The dependent claims of the '554 patent cover methods of breeding and producing chemotype II Cannabis plants with a non-myrcene dominant terpene profile, a cannabis extract, and an edible product using the Cannabis plant described in claim 1.

The next to issue in the Biotech cannabis patents was U.S. Patent No. 9,370,164 ("the '164 patent") on June 21, 2016. Like the '554 patent, the '164 patent covers Cannabis plants with particular cannabinoid content and terpene profile.

Claim 1 of the '164 patent recites:

1. A Cannabis plant, or an asexual clone of said Cannabis plant, or a plant part, tissue, or cell thereof, which produces a female inflorescence, said inflorescence comprising:
    a) a tetrahydrocannabinol (THC) content that is at least 3%;
    b) a cannabidiol (CBD) content that is at least 3%;
    c) a terpene profile in which myrcene is not the dominant terpene; and
    d) a terpene oil content greater than about 1%;
    wherein the contents of THC and CBD comprise acidic and decarboxylated cannabinoids as measured by high performance liquid chromatography (HPLC) and calculated based on dry weight of the inflorescence; wherein the terpene profile is defined as terpinolene, alpha phellandrene, beta ocimene, carene, limonene, gamma terpinene, alpha pinene, alpha terpinene, beta pinene, fenchol, camphene, alpha terpineol, alpha humulene, beta caryophyllene, linalool, caryophyllene oxide, and myrcene, and wherein the terpene oil content is the additive content of the terpenes in the terpene profile;
    wherein the terpene contents are measured by gas chromatography-flame ionization detection (GC-FID) and calculated based on dry weight of the inflorescence; wherein a representative sample of seed producing said plants has been deposited under NCIMB Nos. 42254, 42255, 42256, and 42258.

More recently, the third of the Biotech cannabis patents issued on May 9, 2017, as U.S. Patent No. 9,642,317 ("the '317 patent"). Like the '554 and '164 patents, the '317 patent has an independent claim directed to a Cannabis plant with particular cannabinoid and terpene characteristics, but further claims strains containing specific content ratios of THC:CBD (see claims 18 and 19).

Currently, there is one published pending continuation application in this family — U.S. Patent Application No. 15/400,277, which was filed on January 6, 2017, and published as US 2017/0202170 on July 20, 2017. This case has not yet been picked up for examination, but the pending claims appear to be directed to additional Cannabis varieties. Another application in this family was recently filed and assigned U.S. Patent Application No. 15/795,904; however, this application is currently unpublished. Thus, given the plethora of embodiments disclosed in the specification, Biotech Institute will almost certainly continue to file continuation applications to pursue additional subject matter and to keep an application in the family pending.

Additionally, Biotech Institute has also sought international protection of this family. International Application PCT/US2014/030267 was filed in parallel with the U.S. application that led to the '554 patent and has entered national stage in Mexico. Furthermore, International Application PCT/US2014/046694 was filed on July 15, 2014, and claims priority to the same family. This application entered national phase in Europe and Canada.

So, considering the reach of the Biotech cannabis patents so far, why has this family caused such a stir in the cannabis industry? At first glance, the independent claims of the '554, '164, and '317 patents seem limited in that they require that the Cannabis plants to contain certain percentages of THC and/or CBD and a terpene profile of more than 15 specific terpenes. Some of the independent claims additionally require that myrcene is not the dominant terpene. The independent claims also recite specific deposit numbers of seeds that are representative of the strains described by the independent claims.

However, despite these limitations, commentators have speculated that Biotech Institute's patents may cover anywhere from 50-70% of all Cannabis plants that are currently on the market, which could pose a serious threat to many Cannabis growers.[2] Unlike plant patents, which are narrow and cover a particular, well-defined new plant variety, utility patents directed to plants have the potential to claim a much broader range of varieties.

Further, the potential sweeping scope of these patents, specifically, highlights a couple of issues with prosecuting and challenging patents on Cannabis plants, generally. For example, there would seem to be a lack of prior art available showing the particular chemotypes of strains that are currently in use. Without this information, Examiners are unable to accurately determine whether a Cannabis plant with a particular chemotype is novel and nonobvious. Moreover, the lack of publications or information on the Cannabis varieties currently available to the public may pose similar challenges for third parties seeking to initiate certain post-grant review proceedings before the USPTO of patents covering Cannabis plants. Indeed, perhaps unsurprisingly, none of the patents in this family have yet been subjected to an IPR proceeding.

Regardless of this lack of post-grant challenges or proceedings for the Biotech cannabis patents, however, these concerns have become apparent by other market reactions in the industry. For example, in direct response to these issues and Biotech Institute's patents in particular, groups such as the Open Cannabis Project ("OCP")[3] are working to catalog and publish the chemotype data of cannabis strains that are currently in the public domain. OCP's mission, in part, is to prevent broad utility patent protection of Cannabis plants. Having such a database will help ensure that patents on Cannabis plants are properly limited in scope to cover novel and nonobvious varieties.

For now, it is uncertain whether Biotech Institute's patents are enforceable given the current federal climate. However, as this family of patents is not set to expire until March 2034, the cannabis industry will have to remain careful, diligent, and concerned over Biotech Institute's growing patent family.

[1] Importantly, the USPTO recently issued the first plant patent on December 20, 2016, PP27,475, entitled "Cannabis plant named 'Ecuadorian Sativa.'"
[2] See, e.g., https://hightimes.com/business/patented-pot-a-multimillion-dollar-battle-looms/.
[3] http://opencannabisproject.org/
Supreme Court Preview — Oil States Energy Services, LLC v. Greene’s Energy Group, LLC

November 15, 2017

By Andrew Williams —

On November 27, 2017, the Supreme Court will hear arguments in two cases that were ultimately appealed from IPR Final Written Decisions issued by the PTAB. The first of these, Oil States Energy Services, LLC v. Greene's Energy Group, LLC, will analyze whether IPRs (and presumably other post-issuance proceedings) are constitutional. Specifically, the sole question to be considered by the Court is:

1. Whether inter partes review––an adversarial process used by the Patent and Trademark Office (PTO) to analyze the validity of existing patents––violates the Constitution by extinguishing private property rights through a non-Article III forum without a jury.

This case was appealed from a Federal Circuit Rule 36 affirmance, so there is no appellate decision for the Supreme Court to reference. However, as we reported at the time, the Federal Circuit did previously consider this constitutional issue in MCM Portfolio LLC v. Hewlett-Packard Co. In that case, a three-judge panel concluded that because patents are public rights and "the grant of a patent is primarily a public concern," Congress was able to create administrative procedures for assessing their validity. The outcome was similar to that in the Patlex Corp. v. Mossinghoff case, in which the Court had determined that patents were primarily a public concern, and correspondingly ex parte reexaminations did not violate Article III of the constitution. Nevertheless, not everyone agrees that patents are public rights, and this case will likely turn on whether the Supreme Court instead determines that issued patents are private rights that can only be reviewed in Article III courts. And what will be the outcome? On the one hand, it is not often that the Supreme Court affirms the Federal Circuit, which would suggest the Court will find the proceedings unconstitutional. But it is also difficult imagining this Court taking a decidedly pro-patent position by dismantling the very post-issuance procedures that are responsible for invalidating large numbers of allegedly "bad" patents. Perhaps the oral argument will provide some clarity.

The MCM Portfolio case may have been the last time the Federal Circuit spoke on the constitutionality issue, but various judges expressed their opinions in concurrences and dissents to a denial of a petition for initial hearing en banc. In Cascades Projection LLC v. Epson America, Inc., the Appellant had sought initial en banc review on the constitutionality issue because it believed that the MCM Portfolio case would be controlling on any other panel. Judge Newman concurred because even though she believed that the issue should ultimately be decided by the en banc Court, it would benefit from full consideration by another panel. Judge Dyk, author of the MCM Portfolio opinion, joined by the other two members of the panel (Chief Judge Prost and Judge Hughes), wrote in support of the denial because he believed the prior case was correctly decided (naturally), and wrote to address issues raised by the dissents. Judge O'Malley dissented without expressing any definitive opinion on the merits. Instead, she thought it was far from certain that patent rights are public rights, and therefore this issue deserved the attention of the full court. Finally, Judge Reyna provided a well-reasoned dissent advocating strongly for unconstitutionality. First, he believed that the Supreme Court precedent was clear that only Article III courts had the authority to set aside or annul a patent right. Second, he found the MCM Portfolio and Patlex Corp. decisions to be inconsistent and irreconcilable. Finally, he believed that separation of powers needs to be addressed, adding that the Court "should consider the constraints Article III imposes on the adjudication of patent rights by administrative authority." Of course, all of these opinions will be moot once the Supreme Court decides the present case.

Ultimately, this case may come down to how the Court understands the 1898 case of McCormick Harvesting Machine v. Aultman. In that case, the patentee had sought the add claims via reissuance. However, the Examiner found that at least some of the issued claims were invalid and sought to revoke the patent right. The Supreme Court at the time determined that the Patent Office did not have the authority to do so:

It has been settled by repeated decisions of this court that when a patent has received the signature of the secretary of the interior, countersigned by the commissioner of patents, and has had affixed to it the seal of the patent office, it has passed beyond the control and jurisdiction of that office, and is not subject to be revoked or canceled by the president, or any other officer of the government. It has become the property of the patentee, and as such is entitled to the same legal protection as other property.

The only authority competent to set a patent aside, or to annul it, or to correct it for any reason whatever, is vested in the courts of the United States, and not in the department which issued the patent.

Moreover, the Court stated that "to attempt to cancel a patent upon an application for reissue when the first patent is considered invalid by the examiner would be to deprive the applicant of his property without due process of law, and would be in fact an invasion of the judicial branch of the government by the executive." The Petitioner in the present case, as well as others that believe IPRs are unconstitutional, has taken the position that the statements in McCormick suggest that Congress could not establish any statutory process capable of cancelling or revoking patents once issued by the Office. On the other hand, Respondent Greene's Energy and the Federal Respondent, as well many others arguing for the persistence of IPRs, point out that Congress had not provided the Patent Office with the ability to revoke patents. As a result, the holding in that case turned on a lack of statutory authority, not constitutional authority. In addition, due process can be satisfied (according to this position) by the administrative proceedings, especially because there is the opportunity for appellate review by an Article III court. Interestingly, the McCormick case does not mention or invoke the constitution per se. Nevertheless, it does invoke due process concerns, and many of the cases it cited dealt with the constitutionality of property rights. Cynically, it would seem that the Supreme Court could defensibly adopt either position. Indeed, there are commentators that have noted that this case might be more about the Court's desire to make a pronouncement about the administrative state rather than its desire to control abuses by the Patent Office.

There was significant amicus support for both parties, as well as briefs filed in support of neither party. In the days leading to the argument, we will highlight some of the arguments made. Below is a listing of the filed briefs in the case, as well as links to copies of the briefs (copies of most briefs made available by the American Bar Association)

Merits Briefs

Brief of Petitioner Oil States Energy Services, LLC

Brief of Respondent Greene's Energy Group, LLC

Brief of Federal Respondent

Amicus briefs in support of Petitioner

Brief of 27 Law Professors

Brief of AbbVie, Inc. et al.

Brief of Alliacense Limited LLC

Brief of Biotechnology Innovation Organization (BIO) et al.

Brief of Cato Institute and American Conservative Union Foundation

Brief of Eagle Forum Education & Legal Defense Fund

Brief of Evolutionary Intelligence LLC

Brief of Gary Lauder et al.

Brief of IEEE – USA

Brief of InterDigital, Inc. et al.

Brief of J. Kenneth Blackwell et al.

Brief of LiquidPower Specialty Products Inc.

Brief of Pacific Legal Foundation et al.

Brief of the Pharmaceutical Research and Manufacturers of America

Brief of Professor Dmitry Karshtedt

Brief of Professor James W. Ely, Jr. et al.

Brief of Security People, Inc.

Brief of Thirty-Nine Affected Patent Owners

Brief of Unisone Strategic IP, Inc.

Brief of University of New Mexico

Brief of US Inventor, Inc. et al.

Amicus briefs in support of Respondent

Brief of 72 Professors of Intellectual Property Law

Brief of AARP and AARP Foundation

Brief of Act I The App Association

Brief of Alliance of Automobile Manufacturers

Brief of America's Health Insurance Plans

Brief of Apple Inc.

Brief of Arris Group, Inc. et al.

Brief of Askeladden LLC

Brief of BSA I The Software Alliance

Brief of Dell Inc. et al.

Brief of General Electric Company

Brief of Initiative for Medicines, Access & Knowledge (I-MAK)

Brief of Intel et al.

Brief of Internet Association et al.

Brief of Knowledge Ecology International

Brief of Mylan Pharmaceuticals Inc.

Brief of Professors of Administrative Law et al.

Brief of Public Knowledge et al.

Brief of Professor Lee A. Hollaar

Brief of Retail Litigation Center, Inc. et al.

Brief of SAP America et al.

Brief of Taiwan Semiconductor Manufacturing Co., Ltd.

Brief of U.S. Golf Manufacturers Council

Brief of Unified Patents Inc.

Brief of Volkswagen Group of America

Amicus briefs in support of neither party

Brief of 3M Company et al.

Brief of American Intellectual Property Law Association

Brief of Association for Accessible Medicines

Brief of the Association of Amicus Counsel

Brief of Boston Patent Law Association (BPLA)

Brief of The Civil Jury Project at New York University School of Law

Brief of H. Tomás Gómez-Arostegui and Sean Bottomley

Brief of Houston Intellectual Property Law Association

Brief of Intellectual Property Law Association of Chicago

Brief of Intellectual Property Owners Association

Brief of The Patent Trial and Appeal Board Bar Association

Brief of Shire Pharmaceuticals, LLC
Intellectual Ventures I LLC v. Erie Indemnity Co. (Fed. Cir. 2017)

November 14, 2017

By Michael Borella —

Intellectual Ventures I (IV) brought an action against Erie Indemnity Company in the Western District of Pennsylvania, alleging infringement of U.S. Patent No. 7,757,298. Erie filed a motion to dismiss under Rule 12(b)(6), contending that the claims of the '298 patent did not meet the eligibility requirements of 35 U.S.C. § 101. The District Court granted the motion and IV appealed.

The Supreme Court's Alice Corp. v. CLS Bank Int'l case set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under § 101. One must first decide 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 decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion. But generic computer implementation of an otherwise abstract process does not qualify as "significantly more." On the other hand, a claimed improvement to a computer or technological process is typically patent-eligible.

Claim 1 of the '298 patent recites:

A computer-implemented method for identifying and characterizing stored electronic files, said method comprising:
    under control of one or more configured computer systems:
        selecting a file from a plurality of files stored in a computer storage medium, wherein selecting the file is performed according to at least one of:
            selecting the file based on the size of the file by determining whether an aggregate size of plural identically-sized files exceeds a predetermined threshold;
            selecting the file based on whether content of the file matches a file type indicated by a name of the file; or
            selecting the file based on whether the file comprises data beyond an end of data marker for the file;
        generating an identification value associated with the selected file, wherein the identification value is representative of at least a portion of the content of the selected file;
        comparing the generated identification value to one or more identification values associated with one or more of a plurality of unauthorized files; and
        characterizing the file as an unauthorized file if the identification value matches one of the plurality of identification values associated with the unauthorized files.

According to the patent, the claimed invention "improve[s] upon the prior art by providing a method and apparatus to detect undesirable files stored on computer storage devices according to pre-set criteria." These detected files can be reviewed in order to reduce legal risk to a corporation. For instance, such an entity may be unknowingly or inadvertently storing files that contain copyrighted media or pornography. The patent purports to detect "various characteristics of files . . . that give away illegal, illicit, or offensive content . . . and in so doing, saves Web hosting services from criminal, copyright, or some other liability."

Notably, claim 1 includes three distinct file selection criteria claimed in the disjunctive: the size of the file matches the size of other files and their aggregate size exceeds a threshold (an indication that a potentially copyrighted media file has been broken into smaller chunks in order to hide its presence), the content of the file not matching the filename extension of the file (e.g., a *.jpg file should actually contain a JPEG image), and whether the file contains data beyond its end of file marker (an indication that this extra data may be illicit).

The District Court applied part one the Alice test and found that the '298 patent "merely claims a computerized solution to a longstanding problem that exists outside of computers: identifying and categorizing illicit files, the possession of which might subject an individual or organization to liability." The District Court further found the claimed invention analogous to "a librarian tasked with marking and removing books containing pornographic material from a library." IV asserted that the claims were not abstract because they "improve upon how computer systems detect unauthorized files by teaching a specific way of identifying unauthorized files using specific selection criteria that humans did not use." Indeed, the District Court's analogy is tortured at best, as each of the three selection criteria are specific to problems with computer files, and there are no clear or logical analogies to how a librarian would analyze books, CDs, or DVDs.

The Federal Circuit reviewed the claims and found them "directed to the identification of unwanted files in a particular field (i.e., a computer network) and otherwise concern data collection related to such identification." Based on previous Federal Circuit cases, such as Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat'l Ass'n and FairWarning IP, LLC v. Iatric Systems, Inc., the Court ruled the claims abstract. To back up this decision, the Court pointed to how the specification admits that "selection of errant files generally could be performed by humans" with respect to the first two selection criteria. Regarding the third criterion, the Court noted that it had "found the idea of performing a search to ferret out sources with unwanted material based on characteristics of the source to be directed to an abstract idea." Thus, the Court ruled that the third criterion was also abstract.

In an interesting exchange, IV argued that the claimed invention was similar to that of McRO, Inc. v. Bandai Namco Games America Inc., where a software invention using rules to map audio phonemes to facial characteristics was found to be not abstract under part one of Alice. The Court admitted that "[i]n McRO, we held that, although the processes were previously performed by humans, the traditional process and newly claimed method produced results in fundamentally different ways." But then it went on to state, in a conclusory fashion, that "the claims of the '298 patent merely implement an old practice in a new environment." Perhaps this decision was based on IV not arguing that its claimed method was different from the ones used by humans. The Court also found that, unlike those of Enfish v. Microsoft, the claims of the '298 patent "are not directed to an improvement in the way computers operate," and instead merely use a computer to perform a task faster and more accurately.

IV further argued that the claims were similar to a patent-eligible example claim in the USPTO's Subject Matter Eligibility Guidelines. But the Court rapidly dismissed this point, stating that it was not bound by the Guidelines.

Turning to part two of Alice, the Court set out to decide whether the claim elements, "when viewed individually and as an ordered combination — contain an inventive concept sufficient to transform the claimed abstract idea into a patent-eligible application." The District Court answered this inquiry in the negative, holding that the claims recite "generic functions, even if performed by a computer, that are not inventive because selecting files based on identifiers and matching different files/identifiers is just what computers do." Furthermore, the District Court opined that even though the claims were allowed under the pre-Alice machine or transformation test, this test is "not sufficient to render a claim patent-eligible, as not all transformations or machine implementations infuse an otherwise ineligible claim with an inventive concept."

IV asserted that the claims "recite novel file identification software that analyzes and identifies files in unconventional ways — applying three specific selection criteria and then performing a digital-signature-based lookup process." The Federal Circuit, however, took a different view, finding that the generic computer components of the claims did not amount to significantly more than the abstract idea therein. It is unclear from the opinion whether the Court considered the claims as an ordered combination under part two.

As a consequence, the claims failed both parts of the Alice test and were found ineligible.

Over the last year and a half, the Federal Circuit has effectively compressed the two parts of the Alice test into one. According to Enfish and McRO, one can establish the non-abstractness of a claim, or that the claim contains an inventive concept, by showing that it improves the operation of a computer or a technological process. Here, IV lost this case on the analogies made during the part one analysis. Once the Court settled on the claimed invention being analogous to previously-performed human activity, it essentially ignored any assertion that the claimed invention provides a technological improvement. (Or if the Court did consider such improvements, it did not explain its reasoning in this opinion.)

And the analogies made in this case are . . . not good. Especially with respect to determining "whether the file comprises data beyond an end of data marker for the file," it appears that Erie painted with an overly broad brush, and the Federal Circuit bought into it. When viewed as a whole, the claim is clearly directed to and limited to solving a problem that specifically arises in computing. Maybe the claim is obvious, but the process it describes is not any more abstract than the eligible claim at issue in DDR Holdings v. Hotels.com.

But even if the Court did carefully consider the analogies and did come up with reasoning for why the claim is abstract, an explicit rendition of that reasoning is missing from the opinion. As a result, this is likely to become yet another case, like last year's Electric Power Group v. Alstom, where the USPTO, the district courts, and even the Federal Circuit itself, read the holding so broadly that virtually any method claim can be made to look abstract.

Intellectual Ventures I LLC v. Erie Indemnity Co. (Fed. Cir. 2017)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Reyna and Wallach
Opinion by Circuit Judge Wallach
PTAB Life Sciences Report

November 12, 2017

By John Cravero —

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents.

Sawai USA, Inc. v. Astellas Pharma Inc.

PTAB Petition: IPR2018-00079; filed October 16, 2017.

Patent at Issue: U.S. Patent No. 6,346,532 ("Amide derivatives or salts thereof," issued February 12, 2002) claims amide derivatives represented by a general formula or salts thereof which are useful in the treatment of diabetes mellitus and obesity.

Petitioners Sawai USA Inc. and Sawai Pharmaceutical Co. Ltd are challenging the '532 patent on two grounds as obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '532 patent is the subject of the following patent infringement lawsuits: Astellas Pharma Inc., et al. v. Sawai USA, Inc., et al., No. 16-cv-954-SLR (D. Del. 2016) as consolidated with Astellas Pharma Inc., et al. v. Actavis Elizabeth LLC, et al., No. 16-cv-905- SLR (D. Del. 2016).

ThermiGen, LLC v. Viveve, Inc.

PTAB Petition: IPR2018-00088; filed October 20, 2017.

Patent at Issue: U.S. Patent No. 8,961,511 ("Vaginal remodeling device and methods," issued February 24, 2015) claims a method for remodeling a therapeutic zone within a target tissue, the target tissue comprising tissue underlying an epithelium of female genital tissue comprising at least one of vulva, introitus and vagina tissue, the method comprising: heating the target tissue, and remodeling the therapeutic zone of target tissue, wherein the heating includes heating a portion of the vagina extending from the introitus inwardly to a location from 1 cm to 3.5 cm in from the introitus.

Petitioners ThermiGen, LLC and ThermiAesthetics, LLC are challenging the '511 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (ground 2). View the petition here.

Related Matters: According to the petition, the '511 patent is presently the subject of patent infringement lawsuit: Viveve Inc. v. ThermiGen, LLC, ThermiAesthetics, LLC, and Red Alinsod, M.D., Case No. 16-cv-1189 (E.D. Tex.). Petitioner concurrently filed a second petition for inter partes review of claims 43-58 of the '511 patent (IPR2018-00089; filed 10/20/2017; pending).

ThermiGen, LLC v. Viveve, Inc.

PTAB Petition: IPR2018-00089; filed October 20, 2017.

Patent at Issue: U.S. Patent No. 8,961,511 ("Vaginal remodeling device and methods," issued February 24, 2015) claims a method for remodeling a therapeutic zone within a target tissue, the target tissue comprising tissue underlying an epithelium of female genital tissue comprising at least one of vulva, introitus and vagina tissue, the method comprising: heating the target tissue, and remodeling the therapeutic zone of target tissue, wherein the heating includes heating a portion of the vagina extending from the introitus inwardly to a location from 1 cm to 3.5 cm in from the introitus.

Petitioners ThermiGen, LLC and ThermiAesthetics, LLC are challenging the '511 patent on two grounds as obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '511 patent is presently the subject of the following patent infringement lawsuit: Viveve Inc. v. ThermiGen, LLC, ThermiAesthetics, LLC, and Red Alinsod, M.D., Case No. 16-cv-1189 (E.D. Tex.). Petitioner concurrently filed a second petition for inter partes review of claims 1-42 of the '511 patent (IPR2018-00088; filed 10/20/2017; pending).

Initiative for Medicines, Access & Knowledge, Inc. v. Gilead Pharmasset, Inc.

PTAB Petition: IPR2018-00103; filed October 25, 2017.

Patent at Issue: U.S. Patent No. 7,429,572 ("Modified fluorinated nucleoside analogues," issued September 30, 2008) claims a ((2'R)-2'-deoxy-2'-fluoro-2'-C-methyl nucleoside (β-D or β-L) or its pharmaceutically acceptable salt of the structure.

Petitioner Initiative for Medicines, Access & Knowledge, Inc. (I-MAK) is challenging the '572 patent on three grounds as being being anticipated under 35 U.S.C. § 102(b) (grounds 1 and 2) or as obvious under 35 U.S.C. § 103(a) (ground 3). View the petition here.

Related Matters: According to the petition, the '572 patent is not involved in any ongoing matters.

Initiative for Medicines, Access & Knowledge, Inc. v. Gilead Pharmasset, Inc.

PTAB Petition: IPR2018-00119; filed October 25, 2017.

Patent at Issue: U.S. Patent No. 7,964,580 ("Nucleoside phosphoramidate prodrugs," issued June 21, 2011) claims (S)-2-{[(2R,3R,4R,5R)-5-(2,4-Dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydro-furan-2-ylmethoxy]-phenoxy-phosphorylam- ino}-propionic acid isopropyl ester or a stereoisomer thereof and method for treating subject infected by a virus by administering an effective amount of the compound or a stereoisomer thereof as claimed in claim 1.

Petitioner Initiative for Medicines, Access & Knowledge, Inc (I-MAK) is challenging the '580 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3). View the petition here.

Related Matters: According to the petition, the Petitioner concurrently filed another petition for inter partes review of the '580 patent (IPR2018-00120; filed 10/25/2017; pending).

Initiative for Medicines, Access & Knowledge, Inc. v. Gilead Pharmasset, Inc.

PTAB Petition: IPR2018-00120; filed October 25, 2017.

Patent at Issue: U.S. Patent No. 7,964,580 ("Nucleoside phosphoramidate prodrugs," issued June 21, 2011) claims (S)-2-{[(2R,3R,4R,5R)-5-(2,4-Dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydro-furan-2-ylmethoxy]-phenoxy-phosphorylam- ino}-propionic acid isopropyl ester or a stereoisomer thereof and method for treating subject infected by a virus by administering an effective amount of the compound or a stereoisomer thereof as claimed in claim 1.

Petitioner Initiative for Medicines, Access & Knowledge, Inc (I-MAK) is challenging the '580 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the Petitioner concurrently filed another petition for inter partes review of the '580 patent (IPR2018-00119; filed 10/25/2017; pending).

Edwards Lifesciences Corp. v. Boston Scientific Scimed, Inc.

PTAB Petition: IPR2017-01295; filed April 19, 2017.

Institution of Inter Partes Review; entered October 25, 2017.

Patent at Issue: U.S. Patent No. 8,709,062 ("Stent delivery system having stent securement apparatus," issued April 29, 2014) claims a medical device and a system for delivering a medical device.

Petitioner Edwards Lifesciences Corp. is challenging the '062 patent on three grounds as obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges James A. Tartal, Robert L. Kinder, and Amanda F. Wieker (author) issued a decision instituting inter partes review of whether claims 1–7, 9–15, 17–21, and 23–26 are obvious under 35 U.S.C. § 103(a) over Rupp, Sugiyama, Jendersee, and the knowledge of a person of ordinary skill in the art.

Related Matters: According to the petition, the '062 patent is the subject of the following civil litigation: Boston Scientific Corp. & Boston Scientific SciMed Inc. v. Edwards Lifesciences Corp., No. 16-cv-730 (C.D. Cal.).

Initiative for Medicines, Access & Knowledge, Inc. v. Gilead Pharmasset, Inc.

PTAB Petition: IPR2018-00121; filed October 26, 2017.

Patent at Issue: U.S. Patent No. 8,334,270 ("Nucleoside phosphoramidate prodrugs," issued December 18, 2012) claims a compound and method for treating subject infected by a virus by administering an effective amount of the compound or a stereoisomer thereof as claimed in claim 1.

Petitioner Initiative for Medicines, Access & Knowledge, Inc (I-MAK) is challenging the '270 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3). View the petition decision.

Related Matters: According to the petition, the Petitioner concurrently filed another petition for inter partes review of the '270 patent (IPR2018-00122; filed 10/26/2017; pending).

Initiative for Medicines, Access & Knowledge, Inc. v. Gilead Pharmasset, Inc.

PTAB Petition: IPR2018-00122; filed October 26, 2017.

Patent at Issue: U.S. Patent No. 8,334,270 ("Nucleoside phosphoramidate prodrugs," issued December 18, 2012) claims a compound and method for treating subject infected by a virus by administering an effective amount of the compound or a stereoisomer thereof as claimed in claim 1.

Petitioner Initiative for Medicines, Access & Knowledge, Inc (I-MAK) is challenging the '270 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the Petitioner concurrently filed another petition for inter partes review of the '270 patent (IPR2018-00121; filed 10/26/2017; pending).
Conference & CLE Calendar

November 12, 2017

November 14, 2017 – Patent Quality Chat – "How is an Examiner’s Work Product Reviewed?" (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET)

November 14, 2017 - European biotech patent law update (D Young & Co) – 4:00 am, 7:00 am, and 12:00 pm (ET)

November 14, 2017 – "CRISPR Confusion: A Legal and Practical Analysis for IP Professionals" (Technology Transfer Tactics) – 11:00 am to 12:00 pm (ET)

November 16, 2017 – "Overcoming §103 Rejections for Biotech and Chemical Patents: Recent Decisions and USPTO Guidance" (Strafford) – 1:00 to 2:30 pm (EST)

November 16, 2017 – "Outsourcing Patent Work: Avoiding Pitfalls (Ethics)" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

December 4, 2017 – "Aqua Products, Inc. v. Matal, Answers or More Questions?" – Part II (Federal Circuit Bar Association) – 1:00 to 2:00 pm

***Patent Docs is a media partner of this conference or CLE
USPTO Patent Quality Chat Webinar Series

November 11, 2017

The U.S. Patent and Trademark Office will be offering the next webinar in its Patent Quality Chat webinar series from 12:00 to 1:00 pm (ET) on November 14, 2017. The latest webinar, entitled "How is an Examiner’s Work Product Reviewed?" will be hosted by Sandie Spyrou, Supervisor, Office of Patent Quality Assurance, and Christyann Pulliam, Supervisor, Technology Center 2100, who will discuss how quality fits in to a patent examiner's performance appraisal plan and how the Office of Patent Quality Assurance (OPQA) reviews and provides feedback to examiners.

Instructions for viewing the webinar can be found here.

Additional information regarding the Patent Quality Chat webinar series can be found on the USPTO's Patent Quality Chat webpage.
European Biotech Patent Law Webinar

November 11, 2017

D Young & Co will be offering its next European biotech patent law update on November 14, 2017. The webinar will be offered at three times: 4:00 am, 7:00 am, and 12:00 pm (ET). D Young & Co European Patent Attorneys Simon O'Brien and Matthew Caines will provide an essential update and live Q&A on EPO biotechnology case law.

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here.
Webcast on Overcoming §103 Rejections for Biotech and Chemical Patents

November 11, 2017

Strafford will be offering a webcast entitled "Overcoming §103 Rejections for Biotech and Chemical Patents: Recent Decisions and USPTO Guidance" on November 16, 2017 from 1:00 to 2:30 pm (EST). Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner, Amelia Feulner Baur of McNeill Baur, and Amanda K. Murphy of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel for overcoming §103 rejections for biotech and chemical patents, and review recent judicial and PTAB case law and offer insights to address §103 rejections. The webinar will review the following issues:

• What evidentiary support should counsel provide to bolster its assertion of validity/patentability?
• What tactics should patent counsel implement to overcome §103 rejections for biotech and chemical patents?
• How can patent counsel guide applicants during patent application drafting to reduce the likelihood of rejection?

The registration fee for the webcast is $297. Those interested in registering for the webinar, can do so here.
IPO Webinar on Outsourcing Patent Work

November 11, 2017

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Outsourcing Patent Work: Avoiding Pitfalls (Ethics)" on November 16, 2017 from 2:00 to 3:00 pm (ET). Mukundan Chakrapani of Clairvolex, Michael Gnibus of General Electric, and Michael McCabe of IP Ethics Law will examine the possible hazards that can trip up customers of patent services, and what due diligence and supervision is required to do outsourcing correctly.

The registration fee for the webinar is $135 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.

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