Hologic, Inc. v. Smith & Nephew, Inc.

By Nathan Phares
Satisfying the Written Description Requirement for a Genus based on a Disclosure of a Species of the Genus

May 8, 2017 – Hologic, Inc. v. Smith & Nephew, Inc. is related generally to the written description requirement under 112 paragraph 1 (pre-AIA). The Court of Appeals for the Federal Circuit (CAFC) affirmed the Patent Trial and Appeals Board’s (PTAB’s) decision that a genus, claimed in a child application, was adequately disclosed by a species in the specification of a parent application in accordance with the written description requirement.

Smith & Nephew (appellees) secured U.S. Patent No. 8,061,359 on a surgical endoscopic cutting device and method for the cutting device’s use (the ‘359 patent, issued Nov. 22, 2011). The ‘359 patent claims priority to earlier-filed PCT International Publication WO 99/11184 by the same inventor (the Emanuel PCT, published March 11, 1999).

Claim 1 of the ‘359 patent recites a “light guide” that is “permanently affixed” to a “first channel” of the apparatus. This article focuses on the analysis surrounding the light guide. The Emanuel PCT specifies “a connection 8 for a light source . . . for connection to a fibre optics bundle which provides for lighting” (emphasis added). The Examiner of the ‘359 patent objected to the drawings for not showing the “light guide.” Smith & Nephew addressed this objection by amending the specification to state: “A connection 8 for a light source . . . for connection to a light guide, such as a fibre optics bundle which provides for lighting” (emphasis added). The Examiner issued the ‘359 patent thereafter.

Hologic (appellant) requested inter partes reexamination (IPR) of the ‘359 patent, and the PTO granted the reexamination. The IPR Examiner found that the ‘359 patent could not claim priority to the Emanuel PCT because the “fibre optics bundle” of the Emanuel PCT did not provide adequate written description for the “light guide” of the ‘359 patent’s claims. Thus, priority to the Emanuel PCT was severed, so the Emanuel PCT invalidated the ‘359 patent’s claims as obvious in view of a secondary reference.

Smith & Nephew appealed to the PTAB. The PTAB found that the disclosure in the Emanuel PCT provides sufficient written description for the “light guide” of the ‘359 patent, thereby preserving the priority claim of the ‘359 patent to the Emanuel PCT. Thus, the PTAB reversed the IPR Examiner’s rejection of the ‘359 patent’s claims. A more detailed description of the PTAB’s reasoning is provided below. Hologic appealed to the Federal Circuit and appeared before Judges NEWMAN, WALLACH, and STOLL. Judge STOLL authored the opinion.

Claim 1 of the ‘359 patent reads in relevant part:

1. A method for removal of tissue from a uterus, comprising: inserting a distal region of an endoscope into said uterus, the endoscope including a valve and an elongated member defining discrete first and second channels extending from a proximal region of the elongated member to the distal region, the second channel having a proximal end in communication with the valve such that fluid from the valve is able to flow into and through the second channel to the uterus, and the first channel having a light guide permanently affixed therein and being sealed from the second channel to prevent fluid from the valve from entering the uterus through the first channel. . . (emphasis added).

The specification of the ‘359 patent reads, as amended and in relevant part: “[a] connection 8 for a light source is also present, for connection to a light guide, such as a fibre optics bundles which provides for lighting at the end of lens 13.” Col. 3 ll 55-58.

The specification of the Emanuel PCT reads in relevant part:

“A connection 8 for a light source is also present, for connection to a fibre optics bundle which provides for lighting at the end of lens 13.” Emanuel PCT at 4:34-36. See also U.S. Patent No. 7,249,602, which issued from the Emanuel PCT and of which the ‘359 patent is a divisional, at para. [0030].

Hologic appealed the PTAB’s decision that the ‘359 patent is entitled to priority to the Emanuel PCT.  Specifically, Hologic contended that the obviousness rejection should be reinstated based on the Emanuel PCT not satisfying the written description requirement of pre-AIA 35 U.S.C. 112 paragraph 1.  Hologic contends that the Emanuel PCT does not provide adequate description of the “light guide,” as well as the “permanent affix[ture]” of the light guide in a “first channel” claimed in the ‘359 patent. As stated above, this article focuses on the analysis of the written description of the light guide.

The CAFC affirmed the PTAB’s findings that the Emanuel PCT provides written description support for the claims of the ‘359 patent, and that the ‘359 patent is entitled to claim priority to the Emanuel PCT, using a substantial evidence standard. Thus, the Emanuel PCT is not prior art to the ‘359 patent and the obviousness rejection was reversed.

A summary of the relevant written description law follows. To support priority, the specification of a parent patent must disclose what the child patent claims according to the written description requirement of pre-AIA 112 Paragraph 1. Slip Op. at 6, citing In re Katz at 1322. Ariad Pharm. v. Eli Lilly provides the standard: “based on ‘an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art . . ., the specification must describe an
invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed . . . . In other words, the test for sufficiency is whether the disclosure of the [earlier] application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter’ as of that earlier filing date.” Slip Op. at 7, citing Ariad at 1351.

The PTAB reasoned (and the CAFC agreed) that field of the invention is a predictable art, meaning that a lower level of detail is required to satisfy the written description requirement than for unpredictable arts (e.g., pharmaceutical arts, biological arts, etc.). Slip Op. at 7, citing Ariad at
1351. The PTAB further found that the Emanuel PCT discloses a “light guide” based on the facts that the parties do not dispute that a “fibre optic bundle” is a type of light guide, and that various types of light guides were well-known in the art. Slip Op. at 8. Hologic’s experts did not dispute these points. Because the Emanuel PCT showed possession of a “fibre optic bundle,” because a “fibre optic bundle” is a type of light guide, and because various “light guides” were known in a predictable art, the PTAB concluded that the Emanuel PCT reasonably conveys to a skilled artisan that the inventor of the Emanuel PCT had possession of a “light guide.” The CAFC affirmed.

This decision provides a framework for arguing against a written description rejection of a claimed genus over a disclosed species, particularly in the case of a priority claim to an earlier application. For example, this decision could be used to go after a broader scope in a continuation application, a divisional application, or a utility that claims priority to a provisional. Seek to establish that the specification shows possession of a species of a genus, and that the various other species of the genus are known in the art. After this, you may assert that the genus is adequately described in the specification based on the species. This may be particularly useful in predictable arts, although the prosecutor may lower the bar for obviousness by arguing that the art is predictable or that other species of the genus are known in the art. For the patent drafter, this decision provides a cautionary tale to think in terms of the genus as well as the species – add value for your clients by ensuring that your specification covers reasonable alternatives where possible.

The PTAB also found that the “permanently affixed” element and the “first channel” elements were adequately disclosed in the Emanuel PCT, and the CAFC affirmed – this aspect of the decision is not discussed any further in this article, as it is not particularly instructive for prosecutors.

Download Hologic, Inc. v. Smith & Nephew, Inc.

Two-Way Media LTD v. Comcast Cable Communications, LLC, et al.

By William Gvoth

January 23, 2018 – In Two-Way Media LTD v. Comcast Cable Communications, LLC, et al., 2017 U.S. App. LEXIS 21706 (Fed. Cir. Nov. 1, 2017), the Court of Appeals for the Federal Circuit found that claims of various patents owned by Two-Way Media LTD were directed to ineligible subject matter under 35 U.S.C. § 101 (“101”).

This opinion provides insight into how claims may be construed and how this might impact an analysis of the claims under 101.

Four continuation patents were at issue: 5,778,187 (’187 patent), 5,983,005 (’005 patent), 6,434,622 (’622 patent), and 7,266,686 (’686 patent).  The patents relate generally to a system for streaming audio/visual data over a communications system like the Internet.  Claim 1 of the ’187 patent is representative of all the claims of the ’187 patent and the ’005 patent; claims 1 and 29 are representative of the ’622 patent; and claims 1, 22, 26, and 30 are representative of the ’686 patent.

As an example, and at a high level, claim 1 of the ’187 patent is generally directed to a method for:

  • Converting a plurality of streams of data into a plurality of streams of addressed digital packets;
  • Controlling the routing of the stream of packets in response to selection signals; and
  • Monitoring receptions of packets by the users and accumulating records.

The other representative claims are directed to similar methods or to systems with means plus function claiming similar to the previously described claim.

The common specification describes the invention as a scalable architecture for delivering real-time information (e.g., a distribution architecture integrated with a control architecture).  Embedded in the architecture is a control mechanism that provides for the management and administration of users who are to receive real-time information.  The specification also describes monitoring network conditions and generating records about real-time streams.

The Federal Circuit first analyzed the ’187 and ’005 patents.  Under Step 1 of the Alice test – the district court found that the claims of these patents are directed to the abstract idea of 1) sending information, 2) directing the sent information, 3) monitoring the receipt of the sent information, and 4) accumulating records about receipt of the sent information.  In analyzing this determination, the Federal Circuit stated that “claim 1 recites a method for routing information using result-based functional language…but does not describe how to achieve these results in a non-abstract way.”  Further, the Federal Circuit rejected proposed claim constructions, offered by Two-Way Media, that the claims are tied to the network architecture described in the specification.  In rejecting the proposed claim constructions, the Federal Circuit stated that the “constructions recite only conventional computer components.”

After affirming the analysis of the district court under step 1 of the Alice test, the Federal Circuit analyzed these claims under step 2 of the Alice test.  Under step 2, the district court “found no saving inventive concept” in the claims.  Although the district court acknowledged that the specification describes “a system architecture as a technical innovation,” the claim is not tied to the described architecture.  The Federal Circuit rejected Two-Way Media’s assertions that the “claim solves various technical problems” because the claim recites generic functional language to solve these problems.  In addition, the Federal Circuit stated that the claim does not require anything other than conventional technology and that the claim merely recites a conventional ordering of steps.

After analyzing the ’187 and ’005 patents, the Federal Circuit analyzed the ’622 patent and ’686 patent under the Alice test.  For these patents, the district court concluded that the ’622 patent was directed to “the abstract idea of monitoring the delivery of real-time information to a user…and that the ’686 patent was directed to the abstract idea of measuring the delivery of the real-time information for commercial purposes.”  It is worth noting that the district court, in part, based its conclusion on the preamble of the claims at issue.  The Federal Circuit found no error in the district court citing the preamble in its review.  The Federal Circuit then concluded that the claims are “directed to monitoring the delivery of real-time information to user(s) or measuring such delivery for commercial purposes.”

Under step 2 of the Alice test, the Federal Circuit reviewed the district court’s finding that the claims of the ’622 and ’686 patents did not contain an inventive concept.  Similar to the claims discussed above, the Federal Circuit disagreed with the argument that the district court failed to account for the system architecture and failed to give weight the “nonconventional arrangement of components” of the system architecture.  The Federal Circuit agreed with the district court, stating that the claims do not include an inventive concept.  For example, the claims recite use of an “intermediate computer” and an “intermediate server.”  The Federal Circuit stated that these components are “conventional computer and network components operating according to their ordinary functions.”  Further, the Federal Circuit stated that the steps of the claims “are organized in a completely conventional way – data are first processed, sent, and once sent, information is recorded” and “fail to describe a ‘specific, discrete implementation of the abstract idea’ sufficient to qualify for eligibility under 101.”

One of the main takeaways from this opinion is that even though the specification of the patents at issue arguably recited a novel concept (e.g., a novel system architecture), the claims were not tied sufficiently to that novel concept.  This opinion highlights the importance of the relationship between the claims and the specification with regard to a 101 analysis.  It shows that it may be difficult to argue that broad terms used in the claims are tied to novel concepts described in the specification, unless those broad terms are explicitly, or very clearly, tied to the novel concepts.  For example, for purposes of a 101 analysis and with regard to this opinion, reciting generic devices in the claims, such as an “intermediate server” or an “intermediate computer,” may not sufficiently tie the claims to a novel system architecture described in the specification unless the specification or the claims describe the relationship between the terms and the novel concepts.

Download Two-Way Media LTD v. Comcast Cable Communications, LLC, et al. 

Changes in Patent Language to Ensure Eligibility Under Alice

By Peter Glaser and William Gvoth

December 6, 2017- When a rule becomes a target, it ceases to be a good rule.  In the three years since the Supreme Court issued its opinion in Alice, there have been positive changes to patent applications, but there remains a long-term risk that patent practitioners will use tricks to beat the Alice test.  Here, we focus on the changes to patent applications by drafters, as well as changes to patent applications that have issued since Alice.

*Please note, citations were inadvertently omitted from the original publication of this article. Please contact the authors, directly, to obtain a version of this article including citations*

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Practice Insights in the Wake of Sonix Technology Co., LTD., v. Publications International, LTD

By Kris Rhu

October 30, 2017-  In Sonix Technology Co., LTD., v. Publications International, LTD (Fed. Cir. Jan. 5, 2017), the Federal Circuit found that the term at issue in U.S. Patent No. 7,328,845, i.e. “visually negligible,” did not render the asserted claims indefinite under 35. U.S.C. § 112, second paragraph.

The decision provides insight into how terms of degree in claims are treated and how the specification can be useful in providing an objective baseline in interpreting such terms.

The ‘845 patent of Sonix is directed to using a graphical indicator (e.g. a matrix of small dots) to encode information on the surface of an object, and an optical device that can read the graphical indicator and output additional information.  An example application is a children’s book with icons, where if one scans an icon (e.g. a horse) with the optical device, the book will output a sound (e.g. pronunciation of “horse”).  The patent admits that encoding graphical indicators is not new (e.g. barcode on a book cover), but the invention is an improvement over conventional methods because it renders the graphical indicators “visually negligible.”

The district court granted summary judgment against Sonix finding the patent invalid as being indefinite.  Particularly, the district court found the term “visually negligible” in the claim as indefinite under 35. U.S.C. § 112, second paragraph because the term was “purely subjective” and because the claim language provides no guidance on its meaning.  The court also determined that the specification does not provide a person of ordinary skill in the art “with a meaning that is reasonably certain and defines objective boundaries” of the claim scope.

On appeal, Sonix argued that the requirements and examples in the specification would have allowed a skilled artisan to know the scope of the claimed invention with reasonable certainty and establish that the term depends on human perception, not opinion.  They argued that this was consistent throughout the initial examination and reexamination processes.  Publications argued that there is no objective standard to determine whether something is “visually negligible” because it depends on the vagaries of a person’s opinion.

The Federal Circuit agreed with Sonix and reversed the district court, citing Enzo Biochem, Inc. v. Applera Corp., 599 F. 3d 1325, 1336 (Fed. Cir. 2010), where the court found that the clause “not interfering substantially” did not render a claim indefinite because the intrinsic evidence provided examples for non-interfering structures and criteria for their selection.  Thus, sufficient guidance was given to allow a skilled artisan to compare a potentially infringing product with examples from the specification to determine whether interference is “substantial.”

The court also cited Datamize, LLC v. Plumtree Software, Inc., 417 F. 3d 1342, 1348-1349 (Fed. Cir. 2005), where the court found the term “aesthetically pleasing,” with respect to a look and feel for interface screens, indefinite because the specification provided no guidance to a person making aesthetic choices.  Without any guidance, a determination of whether something is “aesthetically pleasing” was completely dependent on a person’s subjective opinion.

The court further cited Interval Licensing, LLC v. AOL, Inc., 766 F .3d, 1364, 1368 (Fed. Cir. 2014), where the court found displaying content “in an unobtrusive manner that does not distract a user” indefinite because the single example in the specification without more information leaves the skilled artisan to wonder what other forms of display are unobtrusive and non-distracting.  This leaves the skilled artisan to consult the “unpredictable vagaries of any one person’s opinion.”

Here, the Federal Circuit found that the term “visually negligible” does not depend on a person’s taste or opinion, but rather depends on whether something can be seen by the normal human eye.  The court found that this provides an “objective baseline” to interpret the claim, and thus, is not “purely subjective” even though it may be a term of degree.  When turning to the specification to determine whether there is some standard for measuring visual negligibility, the court found that the specification 1) has a general exemplary design for a visually-negligible indicator, 2) states “requirements for the graphical indicators [to be] negligible to human eyes”, and 3) contains two specific examples of visually negligible indicators.  Thus, the court found the existence of examples in the specification distinguishes this case from Datamize, and the existence of an additional example and specific requirements distinguishes the case from Interval Licensing.  The court also found the level of detail in the specification to be closer to that provided in Enzo because it provided guidance on how to create visually negligible indicators and specific examples that provide points of comparison for the result.  Further, the court found that Publications had not provided evidence that human perception varies so significantly that reliance on it as a standard renders the claim indefinite, noting that no one involved in the first or second reexamination had any difficulty in determining the scope of the term “visually negligible.”

The Federal Circuit made one final point about how their holding in this case does not necessarily mean that “the existence of examples in the written description will always render a claim definite, or that listing requirements always provide sufficient certainty.”  The court indicated that they simply held that “visually negligible” is not purely a subjective term and that the written description and prosecution history provided sufficient support to inform with reasonable certainty those skilled in the art of the scope of the invention.

Going forward, the decision provides some instruction regarding potential patent drafting strategies with regard to terms of degree.  For example, the decision highlights the importance of providing sufficient requirements and examples in the written description so that sufficient guidance is provided to those skilled in the art for interpreting such terms.

Download Practice Insights in the Wake of Sonix Technology Co., LTD., v. Publications International, LTD.

Analysis of December 2016 USPTO Subject Matter Eligibility Examples

By Kris Rhu & Paul Gurzo

March 20, 2017- On December 15, 2016, the USPTO published three subject matter eligibility examples focusing on business method claims, which can be found here.  The purpose of these examples is to give guidance on how claims should be analyzed using the 2014 Interim Guidance on Subject Matter Eligibility, recent Supreme Court and Federal Circuit decisions, and recent Memorandums published by the USPTO.  These examples seem to indicate that the power of §101 to restrict patentability has been whittled down since Alice and that the USPTO would like to reduce the number of §101 rejections for technological claims in light of court decisions post-Alice.  Below, we describe each example provided by the USPTO, explain the USPTO guidance for each example, and provide practical practice tips that practitioners can use to help reduce or overcome §101 rejections.

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Drafting Software Patents Amidst the Heightened Standard: The Alice v. CLS Bank Aftershock

September 28, 2016 – Nathan Phares was part of a panel of speakers that discussed software patents in the aftermath of Alice v. CLS Bank. He provided insights and recommendations regarding post-Alice case law, drafting strategies in view of recent software eligibility decisions, and winning prosecution techniques for software patents.

For over 10 years, The Knowledge Group has produced thousands of best in class educational webcasts for a variety of industries and professions including legal, tax, accounting, finance, human resources, risk/compliance, and many others.

Click HERE to order recording of the webinar.

Nathan Phares

Harrity Ranked as Top Firm in Cybersecurity by Juristat

September 21, 2016 – Harrity is ranked in the top 3 of firms prosecuting patent applications in the cybersecurity technology area, as ranked by Juristat.

All firms on the list have had at least 100 disposed applications in the relevant art units during the 10-year period between 2006 to 2015 and are ranked by allowance rate.

Click HERE to read the complete article by Juristat.