THE WRITTEN DESCRIPTION REQUIREMENT TO A CLAIM FOR A GENUS CAN BE SATISFIED IF A SINGLE SPECIES OF THAT GENUS IS DISCLOSED AND OTHER MEMBERS OF THAT GENUS ARE WELL KNOWN IN THE ART
| April 20, 2018
Hologic, Inc. v. Smith & Nephew, Inc. and Covidien LP
March 14, 2018
Before Newman, Wallach, and Stoll. Opinion by Stoll.
Summary:
Hologic, Inc. initiated an inter partes reexamination of U.S. Patent No. 8,061,359 (’359 patent. The ’359 patent claims priority to an earlier-filed PCT application with a nearly identical specification. The PTAB found that S&N’s PCT application has sufficient written description so that it is a proper priority document and is not an invalidating obviousness reference. The CAFC held that since substantial evidence supports the PTAB’s finding that the PCT application provides sufficient written description disclosure of the claimed feature, the ’359 patent is entitled to claim priority to the PCT application.
要旨:
米国特許第8,061,359号の当事者系リイグザミネーションに関するものである。当該特許は先行PCT出願とほぼ同一の明細書を含んでおり、この先行PCT出願に対して優先権を主張していた。米国特許庁審判部は、当該PCT出願は優先権主張に対する十分なサポートを含んでおり、よって、優先権主張は有効であるので、当該PCT出願の国際公開が先行技術になることはないと判断した。連邦巡回控訴裁判所(CAFC)は、米国特許庁審判部の判断を支持した。
Details:
Hologic, Inc. initiated an inter partes reexamination of U.S. Patent No. 8,061,359 (’359 patent), which is owned by Smith & Nephew, Inc. and Covidien LP (“S&N”). The ’359 patent claims priority to an earlier-filed PCT application with a nearly identical specification. The PTAB found that S&N’s PCT application has sufficient written description so that it is a proper priority document and is not an invalidating obviousness reference.
The ’359 patent:
The ’359 patent is directed to an endoscope and a method for removing uterine tissue. Independent claim 1 (representative) recites a method of using an endoscope with a “permanently affixed” “light guide” in one of its two channels:
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 . . . .
After entering the national stage with the PCT application in a parent application, S&N filed a divisional application that later issued as the ’359 patent. The PCT application and the ’359 patent have nearly identical specifications and figures.
During the prosecution of the ’359 patent, the Examiner made an objection to the drawings for not showing the “light guide” recited in independent claim 1. After an interview with the Examiner, S&N amended the specification to traverse the objection as follows:
A connection 8 for a light source is also present, for connection to a light guide, such as a fibre optics bundle which provides for lighting at the end of lens 13.
Finally, the Examiner issued the application as the ’359 patent after the above amendment was made.
Inter Partes Reexamination:
The Examiner found that the ’359 patent could not claim priority to the PCT application because the PCT application did not provide sufficient written description for the ’359 patent claims. In particular, the Examiner asserted that the disclosure in the PCT application of only a “fibre optics bundles” did not provide sufficient written description for “light guides.” Therefore, the Examiner rejected claims of the ’359 patent as obvious over the PCT application (prior art to the ’359 patent claims under pre-AIA §102(b)).
The PTAB:
However, the PTAB found that the disclosure in the PCT application provides sufficient written description support for the claimed “light guide” after briefing and review of expert testimony.
The CAFC:
In re Katz Interactive Call Processing Patent Litig., 639 F.3d 1303, 1322 (Fed. Cir. 2011), the CAFC held that to be entitled to the priority date of the earlier-filed PCT application, “S&N must show that the PCT application discloses what the ’359 patent claims, according to the written description requirement of pre-AIA 35 U.S.C. § 112 ¶ 1”.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the CAFC held that “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.” The CAFC held that this standard is satisfied in this case.
The CAFC affirmed the PTAB’s reversal of the Examiner’s rejection because substantial evidence supports the PTAB’s finding that the PCT application “reasonably conveys to a person of ordinary skill that the inventor had possession of the “first channel having a light guide permanently affixed therein.””
First, the CAFC found that the PTAB properly relied on the fact that both parties do not dispute that a “fibre optic bundle” is a type of light guide, and that various types of light guides are well known in the art. Also, the CAFC found that the PTAB correctly found that Hologic’s own experts did not dispute both points.
Second, the CAFC found that the figures and the specification of the PCT application provide sufficient written description supports.
Therefore, the CAFC held that a person of ordinary skill in the art would have understood that the inventor had possession of a light guide affixed in the “first channel.”
With regard to Hologic’s argument that Figure 1a, which does not show illumination components, shows that the inventor was not in possession of a “first channel having a light guide permanently affixed therein,” the CAFC held that the written description “does not require that every claimed element be illustrated in the figures, particularly in predictable arts and where the element not depicted is conventional” and not “necessary for the understanding of the subject matter sought to be patented.” Therefore, the CAFC held that the lack of illumination components does not undermine the above evidence.
Finally, the CAFC held that prior patents showing the state of the art at the time of the invention and expert testimony regarding that evidence further support the PTAB’s findings. For example, two patents listed on the face of the ’359 patent describe endoscopes with permanently affixed light guides. In addition, S&N experts testified that figures in the PCT application are closer to the two patents describing endoscopes with permanently affixed light guides than other prior art patents directed to removable light guides.
Therefore, the CAFC held that substantial evidence supports the PTAB’s finding that the PCT application provides sufficient written description disclosure of the claimed “first channel having a light guide permanently affixed therein.” The CAFC affirmed the PTAB’s finding that the ’359 patent is entitled to claim priority to the PCT application.
Takeaway:
When amending the specification in response to the Examiner’s rejections, Applicant should be careful not to break a chain of priority.
The written description requirement to a claim for a genus (light guide) may be sufficient if there is a disclosure of a single species of that genus (fiber optics), and the fact that other members of that genus are well known in the art.
With regard to objection the drawings by the Examiner for requiring claimed elements being shown in the drawings, Applicant could traverse this objection by citing this case to argue that the written description “does not require that every claimed element be illustrated in the figures, particularly in predictable arts and where the element not depicted is conventional” and not “necessary for the understanding of the subject matter sought to be patented.”
Tags: drawings > expert declaration > Inter Partes Reexamination > PCT application > priority > written description
