Patent Docs

Commil USA, LLC v. Cisco Systems, Inc. (2015)

May 26, 2015

By Kevin E. Noonan —

The Supreme Court handed down its decision in Commil USA, LLC v. Cisco Systems, Inc. today and in doing so reprised several themes that have emerged over the past decade of the Court's activist approach to patent law. The Court reversed the Federal Circuit (albeit technically that court's decision was vacated) and in the process chastised the Federal Circuit for misinterpreting both patent law and the Court's decision in Global-Tech Appliances, Inc. v. SEB S.A. (2014). The Court also reiterated its belief that patent law is replete with dichotomies (here, between infringement and invalidity), consistent with its "Goldilocks" views regarding the effects of too much versus too little patent protection. And, somewhat bizarrely the Court takes the time to venture into the policy issues surrounding abusive patent litigation seemingly unrelated to the issues before the Court. (To be fair, the Court "sides" with the patentee in its decision, which runs contrary to the general trend but this may be considered the exception that probes the rule rather than any great epiphany by the Court.)

To recap, the technology in this case relates to Commil's patents for implementing short-range wireless networks. "The technical details of Commil's patent are not at issue," according to the Court (which must be a relief — there is something endearingly quaint about how the Court describes the technology:

So it suffices to say, with much oversimplification, that the patent is for a method of implementing short-range wireless networks. Suppose an extensive business headquarters or a resort or a college campus wants a single, central wireless system (sometimes called a Wi-Fi network). In order to cover the large space, the system needs multiple base stations so a user can move around the area and still stay connected. Commil's patent relates to a method of providing faster and more reliable communications between devices and base stations.

And the opinion refers to the Federal Circuit opinion for a discussion of the claims. The case comes to the Court after the Federal Circuit reversed the District Court for ruling that Cisco's evidence that it had a "good faith belief" that Commil's claims were invalid was inadmissible for rebutting liability for inducing infringement. The question before the Court, whether a good-faith belief in invalidity is a defense to induced infringement, was taken for consideration after five of the twelve Federal Circuit judges framed that issue in their dissent to the en banc court's decision not to consider the question itself.

The Court's opinion was written by Justice Kennedy joined by all the Justices except the Chief Justice, who joined Justice Scalia's dissent, and Justice Breyer who did not participate in the decision. In addition, Justice Thomas joined the majority only with regard to the Court's decision on the question presented (Section II-B) and its foray into abusive patent litigation policy (Part III). The holding is simple: "A defendant's belief regarding patent validity is not a defense to an induced infringement claim." But of course the more interesting aspect of the decision is the Court's reasoning in arriving at its decision.

From the outset, the Court states that this conclusion is not limited to inducing infringement under 35 U.S.C. § 271(b) but extends to literal infringement under § 271(a) (a strict liability tort) and contributory infringement under § 271(c) (like inducement, a tort that requires knowledge of the existence of the patent). Before arriving at this question, however, the Court (in Part II-A) revisits its decision in Global Tech, motivated according to the opinion by Commil's argument, supported by the Department of Justice as amicus, that all that is required to satisfy the intent prong of the test for inducement is knowledge of the patent. In particular, Commil and the government argued that intent does not require that the accused infringer knew she was infringing, and the Court rejects this interpretation of its Global Tech decision. The opinion cites language in the Global Tech opinion to the effect that "liability for induced infringement can only attach if the defendant knew of the patent and knew as well that 'the induced acts constitute patent infringement.'" The Court illustrates this with a hypothetical: under the government's view, "even if the defendant reads the patent's claims differently from the plaintiff, and that reading is reasonable, he would still be liable because he knew the acts might infringe. Global-Tech requires more. It requires proof the defendant knew the acts were infringing" (emphasis added).

Turning to the question before the Court, the opinion asserts that "[t]he question the Court confronts today concerns whether a defendant's belief regarding patent validity is a defense to a claim of induced infringement. It is not. The scienter element for induced infringement concerns infringement; that is a different issue than validity." Moreover, "because infringement and validity are separate issues under the Act, belief regarding validity cannot negate the scienter required under §271(b)." The opinion cites Cardinal Chemical Co. v. Morton Int'l, Inc.: "A party seeking a declaratory judgment of invalidity presents a claim independent of the patentee's charge of infringement." 508 U. S. 83, 96 (1993). Invalidity doesn't make the acts non-infringing; it eliminates any liability for them according to the Court, and when infringement is the issue, the patent's validity is not the question to be confronted, the opinion citing Cardinal Chemical Co. The Court perceives a dichotomy at play in these questions: "in Deposit Guaranty Nat. Bank v. Roper, 445 U. S. 326 (1980), the Court explained that an accused infringer 'may prevail either by successfully attacking the validity of the patent or by successfully defending the charge of infringement'" and this choice (for this Court) makes questions of an accused infringer's subjective (albeit "good faith") belief in whether a patent claim is invalid irrelevant to the question of whether she intends to infringe.

The Court finds evidence of Congress's intent to raise this dichotomy in the structure of the Patent Act:

[T]he issues of infringement and validity appear in separate parts of the Patent Act. Part III of the Act deals with "Patents and Protection of Patent Rights," including the right to be free from infringement. §§251– 329. Part II, entitled "Patentability of Inventions and Grants of Patents," defines what constitutes a valid patent. §§100–212.

And in this regard, the Court also notes that non-infringement and invalidity are "two separate defenses" governed by separate sections of the statute and that they can be asserted separately as further evidence of this statutory dichotomy.

The Court then makes the strongest patent-affirming statement it has made in any case over the past decade, when the opinion voices concern with the presumption of validity, which is "a 'common core of thought and truth' reflected in this Court's precedents for a century," citing Radio Corp. of America v. Radio Engineering Laboratories, Inc., 293 U. S. 1, 8 (1934). "[I]f belief in invalidity were a defense to induced infringement," according to the opinion, "the force of that presumption would be lessened to a drastic degree, for a defendant could prevail if he proved he reasonably believed the patent was invalid." This would be a way to "circumvent the high bar Congress is presumed to have chosen: the clear and convincing standard," citing Microsoft Corp. v. i4i Ltd. Partnership, (2011).

In reference to Justice Scalia's arguments in dissent (without ever referencing that there is a dissent), the majority states that it does not dispute Scalia's logic that one cannot infringe an invalid patent, calling the rubric "a simple truth, both as a matter of logic and semantics." But that isn't the issue as the majority sees it:

[T]he questions courts must address when interpreting and implementing the statutory framework require a determination of the procedures and sequences that the parties must follow to prove the act of wrongful inducement and any related issues of patent validity.

The Court then quotes Judge Newman from her dissent: "[v]alidity and infringement are distinct issues, bearing different burdens, different presumptions, and different evidence." 720 F. 3d, at 1374 (opinion of Newman, J.).

The opinion also states that the "orderly administration of the patent system" requires that infringement and invalidity be considered separately, and thus the District Court was correct in ruling evidence of Cisco's belief that Commil's claims were invalid was inadmissible. The jurisprudential point: "invalidity is not a defense to infringement, it is a defense to liability" and thus "a belief as to invalidity cannot negate the scienter required for induced infringement."

The Court also considers the availability of other avenues to show invalidity — declaratory judgment actions, citing MedImmune, Inc. v. Genentech, Inc., 549 U. S. 118, 137 (2007), inter partes review under the AIA (§ 316) or ex parte reexamination (§ 302) (which is what Cisco actually did) as alternative ways for an accused infringer to raise challenges to invalidity, the majority agreeing that claims found to be invalid cannot be infringed (versus permitting mere good faith belief to be enough).

The Court finds an analogy between tortious interference with contract and whether the contract is invalid, which is irrelevant as a defense, or perhaps more aptly, trespass on property without knowledge that the trespasser had no legal right to enter a property not being sufficient to eliminate liability for the trespass.

Just when an opinion by this Court gives the impression that the Court has decided to cabin its role in patent law within its Constitutional boundaries of interpreting the Patent Act and deciding whether Congress has exceeded the limitations on its exercise of the patent power under Article I, along comes Part III of the opinion to shatter the illusion. Here, the Court takes on the issue of "patent trolls," citing Justice Kennedy's concurring opinion in eBay Inc. v. MercExchange, L.L.C., 547 U. S. 388, 396 (2006) (which if memory serves was not the question the Court addressed in eBay). Broaching this issue in this case shows the political nature of the Court's patenting opinions and its penchant for espousing policy. Here, this takes the guise of the castigating practice of pursuing "frivolous" lawsuits that "may assert vague claims of infringement, and may be designed to obtain payments that are based more on the costs of defending litigation than on the merit of the patent claims," citing testimony before Congress by the Federal Trade Commission. These questions have nothing to do with the question before the Court, which the Court admits:

No issue of frivolity has been raised by the parties in this case, nor does it arise on the facts presented to this Court. Nonetheless, it is still necessary and proper to stress that district courts have the authority and responsibility to ensure frivolous cases are dissuaded. If frivolous cases are filed in federal court, it is within the power of the court to sanction attorneys for bringing such suits. Fed. Rule Civ. Proc. 11.

And:

It is also within the district court's discretion to award attorney's fees to prevailing parties in "exceptional cases." 35 U. S. C. §285; see also Octane Fitness, LLC v. ICON Health & Fitness, Inc., 572 U. S. ___, ___–___ (2014) (slip op., at 7–8).

The justification is that:

These safeguards, combined with the avenues that accused inducers have to obtain rulings on the validity of patents, militate in favor of maintaining the separation expressed throughout the Patent Act between infringement and validity.

Which seems a thin reed to support this frolic and detour from the question before the Court.

Justice Scalia dissents, in an opinion joined by Chief Justice Roberts (both of whom dissented in FTC v. Actavis on the question of the presumption of validity), making a very simple point: "[o]nly valid patents confer [a] right to exclusivity — invalid patents do not," citing FTC v. Actavis, Inc. (2013). Accordingly:

Because only valid patents can be infringed, anyone with a good-faith belief in a patent's invalidity necessarily believes the patent cannot be infringed. And it is impossible for anyone who believes that a patent cannot be infringed to induce actions that he knows will infringe it. A good-faith belief that a patent is invalid is therefore a defense to induced infringement of that patent.

Commil USA, LLC v. Cisco Systems, Inc. (2015)
Opinion of the Court by Justice Kennedy, joined by Justice Ginsburg, Alito, Sotomayor, and Kagan, and joined as to Parts II-B and III by Justice Thomas; dissenting opinion by Justice Scalia, joined by Chief Justice Roberts; Justice Breyer took no part in consideration or decision of the case.
Allvoice Developments US, LLC v. Microsoft Corp. (Fed. Cir. 2015)

May 25, 2015

By Michael Borella —

In August, 2009, Allvoice sued Microsoft in the Western District of Washington, alleging infringement of its U.S. Patent No. 5,799,273. In December, 2013, the District Court granted Microsoft's motion for summary judgment finding that Microsoft did not infringe the asserted claims, and that claims 60-68 of the patent were invalid under 35 U.S.C. § 101. Allvoice appealed. The Federal Circuit panel of judges Prost, Dyk, and O'Malley heard arguments, and affirmed the District Court.

Of particular interest is the reasoning behind the finding of invalidity in light of the claim language at issue. As a representative claim of those held invalid, claim 60 recites:

A universal speech-recognition interface that enables operative coupling of a speech-recognition engine to at least any one of a plurality of different computer-related applications, the universal speech-recognition interface comprising:
    input means for receiving speech-recognition data including recognised words;
    output means for outputting the recognised words into at least any one of the plurality of different computer-related applications to allow processing of the recognised words as input text; and
    audio playback means for playing audio data associated with the recognised words.

In other words, Allvoice's invention, as recited by claims 60-68, is directed to a form of application programming interface (API) that allows applications running on a computer to receive the output of a speech recognition program and "to link the relationship between the output data and the audio data to allow the audio data to be played back for any output data which has been dictated."

After discussing the parameters of § 101 in a broad sense, the Court focused in on the four statutory categories listed therein (machines, processes, articles of manufacture, and compositions of matter). Rather than analyzing whether the claims fell into one of the judicial exceptions to these categories (e.g., abstract ideas), the Court considered whether the claimed invention even fit into any of the categories at all.

Noting that "subject matter that falls outside the four statutory categories of § 101 . . . is not patent eligible," the Court explained that "except for process claims, the eligible subject matter must exist in some physical or tangible form." For instance, a machine must be "a concrete thing, consisting of parts, or of certain devices and combination of devices," an article of manufacture must be "a tangible article that is given a new form, quality, property, or combination through man-made or artificial means," and a composition of matter "requires the combination of two or more substances and includes all composite articles."

When before the Court, Allvoice explained that the interface recited by claim 60 consisted of software instructions. The Court did not find this point sufficient to result in the claims meeting the requirements of § 101, because while "[s]oftware may be patent eligible . . . when a claim is not directed towards a process, the subject matter must exist in tangible form." Claims 60-68, in the Court's view, were "software instructions without any hardware limitations" and therefore intangible. Allvoice's proposed construction of the claims' means-plus-function limitations did not involve a tangible form either.

Allvoice contended that "software must necessarily be in a machine readable, physical state in order to exist," and therefore is patent-eligible by its very nature. However, citing Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., the Court observed that "instructions, data, or information alone, absent a tangible medium, is not a manufacture," and thus refused to import a tangible medium into Allvoice's claim language.

The four categories of statutory subject matter cover most anything that one can imagine. For computer-implemented inventions, however, claims directed to pure signals or disembodied data are not within the ambit of § 101. This case serves are a reminder to claim drafters that claiming software as anything but a process can be a tricky endeavor. After all, software instructions are indeed just another form of data, and without a medium to be stored on, lack physical structure.

But, this case also begs the question of what Allvoice could have done in order to mitigate this problem. For instance, if the preamble to claim 60 had read "an article of manufacture including a universal speech-recognition interface . . . ," would the outcome be different? Or, would Allvoice's claims be valid if they had been written in Beauregard style, such as "a non-transitory computer readable medium including computer instructions that, when executed by a processor, cause the processor to perform operations of a universal speech-recognition interface . . . ." Deviation from well-known and well-accepted preambles remains risky.

Allvoice Developments US, LLC v. Microsoft Corp. (Fed. Cir. 2015)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Dyk nd O'Malley
Opinion by Circuit Judge O'Malley
Conference & CLE Calendar

May 25, 2015

May 26, 2015 – "Prosecuting Patents for Sales and Licensing" (American Bar Association (ABA) Center for Professional Development, Section of Intellectual Property Law, and Young Lawyers Division) – 1:00 to 2:30 pm (ET)

May 27, 2015 – "Patent Term Adjustment: 2015 Final Rules" (The Knowledge Group) – 3:00 to 5:00 pm (ET)

May 28, 2015 – "Patent Exhaustion and Its Impact on Patent Licensing" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

May 28, 2015 – "Hedge Fund IPR Challenges to Pharma Patents: Strategies to Strengthen Patents to Withstand Attack" (Strafford) – 1:00 to 2:30 pm (EDT)

May 28, 2015 – "The New EU Unitary Patent & Unified Patent Court: Strategic Considerations for US Applicants/Patentees" (American Bar Association (ABA) Center for Professional Development, Section of Intellectual Property Law, Section of International Law, and Young Lawyers Division) – 1:00 to 2:30 pm (ET)

May 28, 2015 – "Inter Partes Review Strategy and Trends in the Life Sciences Industry: Implications for Patent Prosecutors and Litigators" (Morrison & Foerster LLP) – 8:30 to 10:00 am (PDT)

May 28, 2015 – "Estoppel at the PTAB, with Judge Michael Tierney: Recent Decisions involving 325 (d) and 315 (e)1" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

June 1-2, 2015 – Biosimilars*** (American Conference Institute) – New York, NY

June 4, 2015 – "Navigating Section 112(a) Enablement and Written Description — Withstanding 112(a) Rejections and Attacks on Patent Validity and Patentability" (Strafford) – 1:00 to 2:30 pm (EDT)

June 9, 2015 – "Claim Construction Caselaw Update: Mechanical & Chemical Arts" (American Intellectual Property Law Association) – 12:30 to 2:00 pm (Eastern)

June 9-10, 2015 – Due Diligence Summit for Life Sciences*** (ExL Events) – Boston, MA

June 15-17, 2015 – Fundamentals of Patent Prosecution 2015: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – New York, NY

June 15-18, 2015 – BIO International Convention (Biotechnology Industry Organization) – Philadelphia, PA

June 23, 2015 – "Practical Patent Prosecution Strategies and Considerations" (American Bar Association (ABA) Center for Professional Development, Section of Intellectual Property Law, and Young Lawyers Division) – 1:00 to 2:30 pm (ET)

July 8-10, 2015 – Fundamentals of Patent Prosecution 2015: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

***Patent Docs is a media partner of this conference or CLE
Patent Litigation Report Raises Questions

May 24, 2015

By Grantland Drutchas —

A recent publication by PricewaterhouseCoopers announced that patent suit filings in 2014 had reduced by 13% from the prior year, and concluded that this "dramatic shift" was "[d]riven by Alice Corp. v. CLS Bank, which raised the bar for patentability and enforcement of software patents" (see "2015 Patent Litigation Study: A change in patentee fortunes"). This rather strong attribution has in turn driven a number of news outlets, such as IPLaw 360 and bloggers to pick up the story (see "Patent Lawsuits Took First Dive In Years, Report Says" and "Patent Litigation Study Should Cause Patent Reform Pause").

A more careful analysis of the government's data, however, shows that PricewaterhouseCoopers' theory is almost certainly wrong.

First, the data that PricewaterhouseCoopers relied upon for its "[a]pproximately 5,700 cases" in 2014 statistic (Judicial Facts and Figures (US Courts)) is not for the calendar year 2014, but for the Federal Court's fiscal year, which ran from October 31, 2013 to September 30, 2014. Thus, the data is already pretty old (see "Judicial Business 2014 Tables" at Table C-7, citing 5686 total patent cases filed through September 30, 2014).

Second, the Supreme Court issued its Alice decision on June 19, 2014 (see "Supreme Court Issues Decision in Alice Corp. v. CLS Bank"), only a little over three months before the close of the Court's fiscal year. It is hard to imagine that Alice would have had such a significant effect on the filing of new complaints within just that period of time. In fact, if the 13% annual reduction occurred only in these last 3 1/3 months of the fiscal year, it would have required a 50% reduction of all new patent cases filed in that time period. An unlikely scenario.

A far more comprehensive analysis of new district court filings was performed by Lex Machina (see "Patent Case Trends and the Business of Litigation"), which looked at a monthly comparison for new filings in 2014 over 2013 (calendar year). It also looked at the effect of Alice on case termination, a more directly attributable result. As for new patent filings, however, the data cited by Lex Machina shows that new patent filings were down more than 8% in the first 5 months of 2014 over 2013 (2330 vs. 2537), i.e., even before the Alice Supreme Court decision came out. That downward trend simply continued the rest of the year.

Although Alice, together with the other § 101 decisions issued by the Supreme Court, are impacting and will continue to impact patent litigation, both new case filings and termination of proceedings, it is a little too simplistic to say that the trend in the data cited by PricewaterhouseCoopers was "driven" by Alice.
IPO Webinar on Estoppel at the PTAB

May 23, 2015

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Estoppel at the PTAB, with Judge Michael Tierney: Recent Decisions involving 325 (d) and 315 (e)1" on May 28, 2015 from 2:00 to 3:00 pm (ET). Herbert Hart, McAndrews of Held & Malloy, Ltd.; Stephen Kunin of Oblon; and Hon. Michael Tierney, Patent Trial and Appeal Board, U.S. Patent & Trademark Office will discuss how the Board's view of estoppel may change PTAB practice by, for instance, encouraging petitioners to include alternative claim interpretations in one petition, and by spurring new potential disputes about what constitutes a diligent search. The panel will also discuss the latest on real-party-in-interest/privity considerations that play an important role in estoppel.

The registration fee for the webinar is $130 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
Webinar on Patent Prosecution Strategies

May 23, 2015

The American Bar Association (ABA) Center for Professional Development, Section of Intellectual Property Law, and Young Lawyers Division will be offering a live webinar entitled "Practical Patent Prosecution Strategies and Considerations" on June 23, 2015 from 1:00 to 2:30 pm (ET). Ida Wahlquist-Ortiz (moderator); Jameson Ma of Bookoff McAndrews, PLLC; Richard Goldstein of Goldstein Patent Law; Michael Van Handel of Wilmer Hale; and Carlos Garcia, Counsel – Innovation, Proctor and Gamble, Cincinnati will take attendees through patent application prosecution from the first Office Action through Allowance. The panel will cite examples of common rejections; show participants how to identify the most important aspects of the Examiner's rejection in order to successfully distill that information to his or her client; address the most effective ways to address each issue, whether it is arguing, amending, conducting an interview with the examiner, appealing, or some combination thereof; show how to craft effective strategies that will result in issued patents able to withstand USPTO post- grant proceedings and litigation; and also address various claim strategies resulting from recent Supreme Court, Federal Circuit, and PTO guidance, with respect to joint infringement issues, business methods, and claim construction.

The registration fee for the webcast is $150 for members, $95 for sponsor members, and $195 for the general public. Those interested in registering for the webinar, can do so here.
AIPLA Webinar on Claim Construction in Mechanical & Chemical Arts

May 23, 2015

The American Intellectual Property Law Association (AIPLA) will be offering a webinar on "Claim Construction Caselaw Update: Mechanical & Chemical Arts" on June 9, 2015 from 12:30 – 2:00 pm (Eastern). Elizabeth K. Gemmell of Berenato & White, LLC and Barry J. Herman of Womble Carlyle Sandridge & Rice, LLP will cover various aspects of claim construction, including the importance of providing multiple embodiments, preserving the single embodiment, over-limiting preambles, means-plus-function construction, claim differentiation, and manufacturing practices affecting claim language.

The registration fee for the program is $145 (AIPLA member rate) or $175 (non-member rate). Those interested in registering for the program, can do so here.
Webinar on Prosecuting Patents for Sales and Licensing

May 23, 2015

The American Bar Association (ABA) Center for Professional Development, Section of Intellectual Property Law, and Young Lawyers Division will be offering a live webinar entitled "Prosecuting Patents for Sales and Licensing" on May 26, 2015 from 1:00 to 2:30 pm (ET). Alexander Franco (moderator) of Patent GC; Christopher K. Agrawal of Bookoff McAndrews, PLLC; and Sabrina Chang, Patent Director of Brokerage Services, Epicenter IP Group will give a brief overview of today’s patent brokerage and licensing markets, along with basic valuation principles and metrics to show which aspects of patents are most sought after or avoided. The panel will also identify strategies for both drafting applications and prosecuting patent applications to maximize marketability of patent assets, both individually and collectively as a portfolio, and identify attack plans for positioning both small and large portfolios for sale, including how best to utilize the seller's potentially scarce resources before a sale.

The registration fee for the webcast is $150 for members, $95 for sponsor members, and $195 for the general public. Those interested in registering for the webinar, can do so here.
Patent Profile: DermTech Receives Patent for Method of Detecting Melanoma in Human Subjects

May 21, 2015

By Josh Bosman —

The U.S. Patent and Trademark Office recently issued a notice of allowance for U.S. Application No. 14/199,900, which is entitled "Diagnosis of Solar Lentigo by Nucleic Acid Analysis." The '900 application, which is assigned to the DermTech International, contains claims to a method of detecting melanoma in a human subject. DermTech is a San Diego-based biotechnology company developing and commercializing gene expression tests to facilitate the diagnosis of dermatologic conditions.

Melanoma is the most serious type of skin cancer, but can be treated successfully if it is detected early. Most melanoma deaths can be prevented by surgical excision if they are detected in their early stages. The methods of the '900 application help to enable physicians to determine the nature and extent of suspicious lesions of the skin by providing accurate, objective information to the physicians to improve care while reducing costs. More specifically, DermTech's technology allows the analysis of skin samples collected non-invasively using an adhesive patch.

The '900 application has two independent claims which recite:

Claim 1.    A method of detecting melanoma in a human subject comprising:
    (a) obtaining a sample of a skin lesion suspected of comprising melanoma from a human subject, wherein the skin lesion sample comprises or is suspected of comprising a nucleic acid molecule expressed from C6orf218;
    (b) detecting the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample, whereby the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample in an amount that is greater than the presence of C6orf218 in a non-melanoma sample is indicative of melanoma in the skin lesion sample, wherein detecting the presence of a nucleic acid molecule expressed from C6orf218 is by application of a detectably labeled probe that hybridizes to a nucleic acid molecule expressed from C6orf218; and
    (c) characterizing the skin lesion as having melanoma or not having.

Claim 15.    A method for diagnosing melanoma in a subject, comprising:
    (a) obtaining a sample of a skin lesion suspected of comprising melanoma from a subject, wherein the skin lesion sample comprises or is suspected of comprising a nucleic acid molecule expressed from C6orf218;
    (b) detecting the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample, wherein detecting the presence of a nucleic acid molecule expressed fromC6orf218 is by application of a detectably labeled probe that hybridizes to a nucleic acid molecule expressed from C6orf218; and
    (c) comparing the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample to the presence of C6orf218 in a non-melanoma sample, whereby the increased presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample as compared to the non-melanoma sample is indicative of melanoma, thereby diagnosing the skin lesion as having melanoma.

A review of the file history of the `900 application (examined under Track I) indicates a rejection under 35 U.S.C. § 101 was issued (along with rejections under §§ 112, 102, and 103) in the first Office Action, mailed December 10, 2014. The Action stated that the claimed invention was directed to patent ineligible subject matter. Specifically, the Action asserted that the claims were directed to a natural correlation or a natural principle (i.e., the claims reflect the natural correspondence between gene expression and melanoma). Furthermore, the Action asserted that the claimed methods failed to incorporate steps that amount to significantly more than the natural principles themselves because the steps merely incorporate conventional, routine techniques while failing to incorporate some other inventive concept.

In response, with respect to the 101 rejection, the Applicant argued that the claims, as amended, are patent eligible because the amended claims do not seek to tie up the use of C6orf218, and others are not excluded from using C6orf218 or C6orf218 expression products in other ways that do not utilize the claimed methods for detecting or diagnosing melanoma. Furthermore, the Applicant argued that the claims as amended are not directed to a judicial exception because the claims are directed to methods of using "a detectably labeled probe that hybridizes to a nucleic acid molecule expressed from C6orf218" and to determine the presence of C6orf218 for "detecting melanoma in a human subject" or for "diagnosing melanoma in a subject".

Finally, the Applicant argued that the amended claims recite an inventive concept because claims 1 and 15, provide methods for "detecting melanoma in a human subject" or for "diagnosing melanoma in a subject," by "detecting the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample," which, according to the Applicant, is not taught, alone or in combination, by the art cited in the Action.

Claims 1 and 15 as amended recited:

Claim 1.    A method of detecting distinguishing melanoma from dysplastic nevi or normal pigmented skin in a human subject comprising:
    (a) obtaining a sample of a skin lesion suspected of comprising melanoma from a human subject, wherein the skin lesion sample comprises or is suspected of comprising a nucleic acid molecule expressed from C6orf218;
    (b) detecting the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample, whereby the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample in an amount that is greater than the presence of C6orf218 in a non-melanoma sample is indicative of melanoma in the skin lesion sample, wherein detecting the presence of a nucleic acid molecule expressed from C6orf218 is by application of a detectably labeled probe that hybridizes to a nucleic acid molecule expressed from C6orf218analyzing expression of a nucleic acid molecule encoded by C6orf218; and
    (c) characterizing the skin lesion as having being melanoma or not having ,dysplastic nevi, or normal pigmented skin, thereby distinguishing melanoma from dysplastic nevi or normal pigmented skin in a human subject.

Claim 15.    A method for diagnosing melanoma in a subject, comprising:
    (a) obtaining a sample of a skin lesion suspected of comprising melanoma from a subject, wherein the skin lesion sample comprises or is suspected of comprising a nucleic acid molecule expressed from C6orf218;
    (b) detecting the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample, wherein detecting the presence of a nucleic acid molecule expressed fromC6orf218 is by application of a detectably labeled probe that hybridizes to a nucleic acid molecule expressed from C6orf218; and
    (c) comparing the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample to the presence of C6orf218 in a non-melanoma sample, whereby the increased presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample as compared to the non-melanoma sample is indicative of melanoma, thereby diagnosising the skin lesion as having melanoma providing a gene expression profile of a target area suspected of being melanoma on the skin of the subject; and
(b) analyzing the subject's gene expression profile with respect to a reference gene expression profile obtained from a corresponding normal skin sample, wherein the reference gene expression profile comprises an expression value of a target gene that is C6orf218.

The file history indicates that a search was performed by the Examiner following the Applicant's response, but the notice of allowance mailed on March 30, 2015 provides no additional comments concerning the allowability of the claims other than noting that the application is in condition for allowance.
Final “Ministerial” Rule Amendments for Practice Before the PTAB

May 20, 2015

By Andrew Williams —

On May 19, 2015, the U.S. Patent and Trademark Office published its first "Final Rules" package of amendments to the Rule of Practice before the Patent Trial and Appeal Board ("PTAB"). Keeping with Director Lee's announcement on March 27, 2015 (see "USPTO Director Announces "Quick-Fix" and Anticipated Changes to PTAB Practice"), this set of rules was described as including more ministerial changes. The Office promised a second set of rules that will address more "involved" changes to the rules. These rules changes stemmed from a "nationwide listening tour" last year, which culminated in a request last June for public feedback about the AIA post-grant proceedings. This request was in the form of seventeen questions. According to the current Final Rules, thirty-seven comments were submitted from individuals, corporations, bar associations, and law firms. The Office promised to address all of these comments that do not involve changes to page limitations in the second rule package later this year. Please find below the changes made in the current rules package:

Patent Owner's Motion to Amend

In perhaps the most significant change of the current rules package, the Patent Office is increasing the page limit for Motions to Amend by ten pages (to a total of twenty-five pages), and removing the necessity of including the claim listing within this limit. Instead, the claim listing can now be provided in an appendix. In order to keep things equivalent, the Office also increased by a commensurate amount the number of pages for an opposition to the motion to amend. The Office had received a wide range of suggestions to deal with this issue, including creating a flexible page limit based on the number of substitute claims, or allowing the patent owner to allocate any unused pages from the Patent Owner's Response. However, these suggestions would have been difficult to administer.

Petitioner's Reply

This Office is also increasing the page limit for the Petitioner's reply brief from fifteen pages to twenty five. The problem was that fifteen page was believed to not be commensurate with the Patent Owner's response. This was especially problematic for the petitioner when the Patent Owner raised new issues in the response. One suggestion was to increase the number of pages by a flexible amount, to be set by the amount of space addressing new issues. However, this too would have been difficult to administer.

Required Font

The new rules will require the use of 14-point Times New Roman proportional font, with normal spacing. Originally, the Office only required a proportional or monospaced font, 14-point or larger (with the additional requirement that monospaced font not contain more than ten characters per inch. However, because parties have used overly narrow fonts that met the letter of the rule, but proved difficult to read, the Board is now going to require uniformity in font type to ensure readability.

Counsel

The Office is clarifying that more than one back-up counsel can be designated. This will be accomplished with an amendment to 37 C.F.R. § 42.10(a), changing "a" to "at least one."

Fees

The Office is requiring that fees due under 37 C.F.R. § 42.15 be based on not only the number challenged claims, but also on the claims from which they depend (unless already included). The reason given was that, in order to understand the scope of a dependent claim, it is necessary to also construe the claims from which it depends.

Oppositions and Replies and Page Limits for Petitions, Motions, Oppositions, and Replies

The Office is clarifying that a statement of material fact in an opposition or reply is optional. 37 C.F.R. §§ 42.23 and 42.24 are amended to make this clear.

Discovery

The Office is also clarifying that routine discovery includes only the cross-examination of affidavit testimony. Nothing more.

Taking Testimony

37 C.F.R. § 42.53(c)(2) is being amended to clarify that uncompelled direct testimony must be in the form of an affidavit.

Motions in Limine

The rules do not provide for motions in limine, but the term was include at 37 C.F.R. § 42.64. This reference is being deleted.

Oppositions

37 C.F.R. § 42.64(b)(1) is being amended to require the filing of objections to the admissibility of evidence, rather than just service as originally required. The problem stemmed from the fact that motions to exclude evidence require identification in the record when the objection was first made. However, when they were only served and not filed, the objections did not become part of the record. This amendment solves that problem.

Decision on Petition or Motion

The Office is clarifying that a party may only file one request for rehearing as a matter of right.

The Office also made a couple of changes to the transitional program for covered business method patent review. First, it was clarified that the pendency of the review can be extended. Second, the Office clarified that a petitioner is barred from challenging the validity of patent if it already filed a civil action challenging the validity of a claim.

As mentioned, there will be a second rules package that will hopefully come out later this year. According to Director Lee's announcement of about two months ago, we can expect to see in this second package, modifications to the motion to amend process; adjustments to the evidence a patent owner can provide in a preliminary response; and clarification of the claim construction standard as applied to expired patents in AIA proceedings. We will, of course, report the new rules package once they are published.

And finally, we do wish to acknowledge that on the same day as this rules package, PTAB Chief Judge James Smith announced that he will be stepping down from that position later this year (according to a report from Law360). Judge Smith was appointed to the position in 2011, when it was known as the Board of Patent Appeals and Interferences. In addition, Judge Smith has been the only Chief Judge of the PTAB, which was created by the America Invents Act ("AIA") in 2012. Not only was Judge Smith required to oversee the implementation of the new post-grant proceedings introduced by the AIA, but he was responsible for handling the backlog of appeals in other cases, such as prosecution appeals and reexaminations. Nevertheless, Judge Smith in generally thought to have performed admirably in his tenure at that position. We wish Judge Smith success in his future endeavors, and thank him for a job well done over the past four years.

For those interested in these topics, and would like to get (or share) more recent happening at the PTAB, we would like to remind everyone of the PTAB TRIALS group on LinkedIn, which provides up-to-date information on IPR, PGR and CBM Info. That group will continue to cover the roll-out of the new AIA post-issuance proceeding rule packages. And, of course, we will continue to cover any significant updates here on Patent Docs.

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