I previously wrote about Allergan USA, Inc. v. MSN Laboratories Private Ltd. (Sun Pharma), No. 24-1061 (Fed. Cir. Aug. 13, 2024), focusing on Federal Circuit’s about-face on obviousness-type double patenting. My original post skipped over an important aspect of the opinion: the court’s 2-1 decision favoring the patentee on the written description requirement of 35 U.S.C. § 112(a). This portion of the case focuses once again on when an element is “essential” to the invention and therefore required in the claims.
Four key takeaways:
We presume that no element is “essential.”
Courts should look for indications in the patent documents that the feature is critical, essential, etc.
The court here relied upon broad claims in the priority filing that were later deleted in order to show the inventor possessed embodiments that did not require the element.
The key focus for written description is comparing the specification with the claims. Although expert testimony may be relevant, it must be directly tied to the intrinsic record.
All of these elements point to the idea that it is the job of the patent drafter and prosecutor to ensure the written description is sufficient, and to avoid pitfalls that might indicate otherwise. (more…)
Ikorongo Technology has filed a petition for certiorari asking the Supreme Court to overturn the Federal Circuit’s heightened disclosure standard for the “same invention” requirement in reissue patents. The petitioner argues that the Federal Circuit’s test, established in Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354 (Fed. Cir. 2014), directly contradicts the Supreme Court’s decision in U.S. Industrial Chemicals, Inc. v. Carbide & Carbon Chemicals Corp., 315 U.S. 668 (1942). Petition for Writ of Certiorari, Ikorongo Tech. LLC v. Bumble Trading LLC, No. 23-1118 (U.S. Apr. 2024).
Reissue has long been a part of the U.S. Patent system, and today’s guiding statute (35 U.S.C. 251) looks substantially the same as that enacted back in 1836. The basic idea is that a defective patent can be “surrendered” and a new patent issued “for the same invention.” (more…)
Just in time for my early August floating trip down in the Ozarks, the Federal Circuit has affirmed the USPTO’s rejections of Float’N’Grill’s proposed reissue claims. The problem: the reissue claims omit an “essential element” of the original invention in violation of 35 U.S.C. 251. The case here is quite similar to the maligned essential elements test of Gentry Gallery, but relies upon the reissue statute rather than the written description requirement of Section 112(a).
Float’N’Grill’s US 9,771,132 covers a floating grill. In patent lingo, we call this a “floating apparatus with grill supports” to allow grilling while floating in water. The disclosed embodiment uses magnets to removably secure the grill to the grill supports, and the original claims required a plurality of magnets. After the patent issued, the patentee recognized that the magnet limitation was unduly narrow. The broadening reissue was filed within the two-year 112(d) deadline and replaced the magnet limitation with one requiring the portions to be “removably securable.”
This is a Shark Tank innovation that got investment (video below). Before getting an investor, these guys filed a low quality initial patent application that had unduly narrow claims that were exploited by knock-off versions and really just disclosed a single embodiment. They got a notice of allowance within a year and paid the issue fee without a continuation. In its decision, the Federal Circuit rejected their reissue patent claims on what is clearly a technicality and one that is extremely biased toward those who spend more on patent prosecution. Patent holders with more money would drafted a more “lawyerly” initial patent application that included wiggle room boilerplate statements and additional prophetic embodiments; and would have kept a continuation application alive. Either of those strategies would have saved the broader claims.
The Original Patent Requirement: Section 251 requires that the reissue claims be directed to “the invention disclosed in the original patent.” And here, the problem, according to the PTO and Federal Circuit, is that the magnets was essential to the invention as originally disclosed.
The key precedent on point is U.S. Industrial Chemicals, Inc. v. Carbide & Carbon Chemicals, Corp., 315 U.S. 668 (1942). In that case, the Supreme Court rejected a set of reissue claims on similar grounds. The original specification highlighted the inclusion of water to improve the efficiency of a reaction. Later, in the reissue, the patentee removed the water requirement. In its analysis, the Supreme Court concluded that water was “a necessary step” in the invented process “essential in the original patent.” As such, the claim omitting water was improperly added in the reissue.
In US Industrial Chemicals, the court also remarked that the original patent requirement goes beyond the ordinary limits of Section 112. The test is not passed simply by showing that the proposed invention “might have been claimed in the original patent because it was suggested or indicated in the specification.”
The Federal Circuit reaffirmed these principles in Forum US, Inc. v. Flow Valve, LLC, 926 F.3d 1346 (Fed. Cir. 2019). In that case, the original patent document disclosed several different machining implements, each having multiple arbors. The patent also described advantages of the multiple-arbor arrangement. In the reissue though the patentee attempted to remove the multiple-arbor requirement in favor of a more generic support. In its opinion, the Federal Circuit concluded the proposed claims were invalid for failure to satisfy the original patent requirement. The court noted that the patent document failed to suggest anywhere “that arbors are an optional feature of the invention.” See also Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354, 1358 (Fed. Cir. 2014).
Techtronic Indus. v. International Trade Commission and The Chamberlain Group (Fed. Cir. 2019) (TechtronicvITC)
Chamberlain’s patent at issue here claims a garage door opener motor drive unit with two microcontrollers — one of which is sited in a “wall console” and the other presumably in the head unit, although this second portion is unclaimed. U.S. patent No. 7,161,319.
1. An improved garage door opener comprising a motor drive unit for opening and closing a garage door,
said motor drive unit having a microcontroller and a wall console,
said wall console having a microcontroller,
said microcontroller of said motor drive unit being connected to the microcontroller of the wall console by means of a digital data bus.
The accused infringer is Hong-Kong based TTI. TTI owns Ryobi, and Ryobi makes the accused garage door opening system. hamberlain filed its case in the USITC which issued exclusion orders against the appellants. On appeal, the Federal Circuit has reversed and vacated on claim construction.
Infrared Detector: It is clear from the patent document that the inventor’s saw the main point of their invention as a passive infrared detector housed in a wall console.
SUMMARY OF THE INVENTION: A passive infrared detector for a garage door operator … contained in a wall control unit.
‘319 patent, invention summary. This focus on the passive infrared detector is found throughout the patent document. Consider the inventor’s statement of the problem to be solved by the invention:
What is needed then is a passive infrared detector for controlling illumination from a garage door operator which could be quickly and easily retrofitted to existing garage door operators with a minimum of trouble and without voiding the warranty.
‘319 patent, background. The easy retrofit solution was to create a wall-unit with an infrared detector. Further, the only described embodiment places the passive infrared detector in the wall console.
Now, look back up at claim 1 and notice that a passive infrared detector is not expressly claimed. That limitation was spelled out in claims of the parent patent, but Chamberlain’s patent attorney at Fitch Even removed it from this continuation patent.
USITC decisions are made by the six commissioners (currently only five), but the Commission tasks an Administrative Law Judge (ALJ) to conduct the trial. Here, the ALJ narrowly construed the “wall console” term — holding that “Chamberlain
… disavowed wall consoles lacking a passive infrared detector.” This construction is important because Ryobi’s wall console does not have a passive infrared detector — thus, the narrow construction meant no infringement.
The Commissioners then took-up the ALJ’s decision and disagreed — ultimately giving “wall console” its ordinary broad meaning that resulted in an easy infringement finding (and resulting exclusion order preventing importation of Ryobi products).
On appeal, the Federal Circuit reviewed the claim construction de novo and found that the ALJ’s original decision was correct. “Chamberlain disavowed coverage of wall consoles without a passive infrared detector.”
[W]here the inventor … has manifested that the invention does or does not include a particular aspect, that intention is regarded as dispositive.
Here, such statements regarding the invention fall into the disavowal category – and must be “clear” although not necessarily “explicit.”
We conclude that the ’319 patent disavows coverage of wall consoles lacking a passive infrared detector because the specification, in each of its sections, discloses as the invention a garage door opener improved by moving the passive infrared detector from the head unit to the wall console. It is axiomatic that, where the specification “describes ‘the present invention’ as having [a] feature,” that representation may disavow contrary embodiments. See Poly-America (“[A]n inventor may disavow claims lacking a particular feature when the specification describes ‘the present invention’ as having that feature.” The ’319 patent, by consistently representing the invention as the placement of the detector in the wall console, has thus effected a disavowal of alternative locations.
According to the background section, the prior art taught the use of passive infrared detectors in the head unit of the garage door opener to control the garage’s lighting, but that locating the detector in the head unit was expensive, complicated, and unreliable. The ’319 patent therefore sets out to solve the need for “a passive infrared detector for controlling illumination from a garage door operator which could be quickly and easily retrofitted to existing garage door operators with a minimum of trouble and without voiding the warranty.”
The remaining sections of the patent—even the abstract—disclose a straightforward solution: moving the detector to the wall console.
Chamberlain argued that the patent recites a separate relating to programming of the microcontrollers. However, the Court rejected that argument:
The suggestion that the patent recites another invention—related to programming the microcontroller—in no way undermines the conclusion that the infrared detector must be on the wall unit. . . . But the entire purpose of [the microcontroller programming] part of the description is to enable placement of the detector in the wall console, and it never discusses programming the microcontroller or applying digital signaling techniques for any purpose other than transmitting lighting commands from the wall console.
The court appears to note that one problem with this additional invention is that the specification was not very specific. The claimed “digital data bus”, for instance, is not expressly discussed in the specification other than an oblique reference to “lines carrying the normal wall control switch signals.”
Chamberlain also argues that disavowal is not clear because nothing in the specification suggests that it would be impossible or infeasible to put a passive infrared detector elsewhere. On appeal, the Federal Circuit found some merit to that argument, but concluded that the specification here “plainly represents the scope of the invention to the exclusion of some embodiments.”
Here, the entire specification focuses on enabling placement of the passive infrared detector in the wall console, which is both responsive to the prior art deficiency the ’319 patent identifies and repeatedly set forth as the objective of the invention. Thus, the ’319 patent disavows locating the detector elsewhere, even without an express concession to that effect.
Slip Op. Although not cited here, this case reminds me substantially of Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998) and its maligned “omitted elements” test.
After conducting an investigation, a divided majority of commissioners of the USITC found no-violation of Adrian Rivera’s U.S. Patent No. 8,720,320 directed toward a re-usable K-cup that work with coffee pods. Investigation No. 337-TA-929. In particular, the decision found all asserted claims invalid for lack of written description. On appeal, the Federal Circuit has affirmed — finding substantial evidence supported the Commission’s holding.
The original set of claims focused on a cup (brewing chamber) designed to hold a “pod” using a “pod adaptor assembly.” However, during prosecution, the patentee cancelled those original claims and replaced them with ones more broadly directed to a “container . . . adapted to hold brewing material.” The expansion captured within its scope competitors who created reusable K-cups that hold loose grounds (instead of pods) that include a filter integrated into the cup.
Section 112 of the Patent Act requires the patentee to submit “a written description of the invention.” Timing-wise, this Written Description Requirement is been interpreted require the full description at the time of filing of the application. The difficulty for many patent applicants is that the scope of the claimed invention can change significantly during prosecution through the amendment process. Problems arise both when patentees attempt to narrow claims to overcome prior art and also (as here) expand claim scope to capture market developments. During prosecution, a written description problem is usually identified as improper “new matter” and is correctable. During infringement litigation, however, a claimed invention lacking sufficient description in the specification will be found invalid and unenforceable.
The test for written description is an objective inquiry that considers whether the original specification “shows that the inventor actually invented the invention claimed.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The Federal Circuit considers written description a question of fact. This means that the appellate court gives deference to the lower court/agency determination on appeal.
Focus on the Infringement: At the litigation stage, courts (including the Federal Circuit) considering the written description requirement have a tendency to shift its gaze from the claims and instead also include the accused device in the analysis. Here, the court looked at the accused Solofill cups that include the particular differences from Rivera’s original disclosure: (1) Solofill cups use loose grounds rather than coffee-pods; and (2) Solofill cups include a filter integrated into the cup itself.
Taking this infringement-focused approach, the claimed “container . . . adapted to hold brewing material” can only work with loose grounds if the container includes a filter of its own. And, the patent specification does not indicate that configuration is part of the invention. As such, the claims fail the written description requirement and therefore are invalid.
The outcome here is similar to that of ICU Medical v. Alaris Medical System (Fed. Cir. 2009) and Liebel-Flarsheim v. Medrad(Fed. Cir. 2007) (though an enablement case).
Not Enablement: One of Rivera’s failed arguments is that a person of skill in the art could quite easily make the integrated filter since they were already known in the art. On appeal, the Federal Circuit rejected that argument — holding that this argument goes toward enablement, which is separate and distinct from written description. For its part, the purpose of the written description requirement is to prove that the inventor actually possessed the invention – and thus requires disclosure in the specification.
Omitted Element: This case is similar to other omitted element cases. In his email, Prof Wegner writes: “The patented claims were broader than all disclosed embodiments: The claims omitted one of the features common to all embodiments of the patent application as filed.”
The vast majority of written description problems arise when the patentee amends or adds claims with limitations not found in the original claim set and using language that does not directly map to specification disclosure. In Cisco Systems v. Cirrex (Fed. Cir. 2017), the Federal Circuit provides an example of this in practice.
After the PTO initiated an inter partes reexamination, the patentee (Cirrex) dropped the original claims (1-34) and added new claims (35-124) of its ‘082 patent.[1] In its final decision, the PTAB affirmed the examiner’s decision that most of the added claims were invalid as lacking written description support. The Board did, however, find five of the claims patentable. On appeal, the Federal Circuit partially reversed – finding all of the claims invalid as lacking written description support.
35 U.S.C. § 112(a) serves as the statutory source for three patentability doctrines: Written Description, Enablement, and Best Mode.
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
In Ariad, the Federal Circuit wrote that the original written description filed by the patentee must “clearly allow persons of ordinary skill in the art to recognize that [he] invented what is claimed.”[2] Channeling the old fox-law case of Pierson v. Post, courts have held that the requirement is intended to show “possession” of the claimed invention at the time of filing. Whether the written description is sufficient is a question of fact – with the level of detail depending upon “the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Thus less description is necessary to show possession in simple technologies in predictable areas. More description is likely required to show possession of novel structures and arrangements as compared to elements found in the prior art.
Here, the added claims at issue here are related to either equalization or discrete attenuation of fiber optic signals inside a lightguide (PLC).
The problem for Cirrex, according to the court, is that the original specification “lacks any disclosure or suggestion of how placing attenuation material inside the PLC … would result in equalizing the intensities of different wavelengths traveling in the PLC, or discretely attenuating a particular wavelength in the PLC.” Rather, the disclosed embodiments teach equalizing to light energy outside the PLC and only collective (rather than discrete) attenuation within the PLC. As such, the Federal Circuit held the claims lacked sufficient written description.
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Alt: Essential Element Test: An interesting issue that the court avoided stems from an odd line of written description cases that center on what the Federal Circuit repeatedly denies is an “essential element” test. In Gentry Gallery, Inc. v. Berkline Corp.[3], the patentee amended claims to remove a previously recited limitation (placement of recliner controls between two recliners). In that case, the court held that the broader claim lacked written description since the specification indicated possession of only a much narrower invention. The basic conclusion is was that since the specification consistently described the invention as including “A, B, and C all connected together,” the patentee cannot broaden its claims to claim just A and B connected together (even if there would be no enablement problem). Whenever the court cites Gentry, it almost always restates the seemingly contrary statement that this test should not be seen as an ‘essential element’ test but rather merely an inquiry as to whether the inventor possessed the invention now claimed.
Here, the challenger argued, in the alternative, that if the claims should also be invalid if interpreted to be broad enough to include equalizing activity whether inside or outside the PLC. The problem is that all disclosed equalizing includes operating on signals outside the PLC, and the challenger argued that the disclosure does not then extend to the full scope of the claims. This argument roughly follows the LizardTech decision where the court held that a broadened claim lacked written description because there was no showing of possession of the “full breadth of the claim.”[4]
This alternative argument was avoided in the appellate decision because the court more narrowly interpreted the claims as discussed above.
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Broadest Reasonable Interpretation vs. Interpretation Most Likely to Invalidate: The court here did not discuss how BRI applies to its claim construction approach. The theory behind BRI is that a broader claim interpretation typically makes it more likely to invalidate claims, and that approach helps ensure that patents released by the PTO are more likely to be upheld as valid. The interpretation issue is typically the opposite for written description issues. Let me explain – since the standard written description problem involves adding new particular limitations into the claims that are absent from the specification, a more narrow interpretation of the claims is actually more likely to invalidate. (Here, I set aside the aforementioned LizardTech improper broadening issue.) The query here is whether the PTO should be applying the reasonable interpretation most likely to invalidate rather than broadest reasonable interpretation.
[2] Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991)).
[3]Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1479 (Fed. Cir. 1998).
The interesting and long-running Zoltek case has received another decision from the Federal Circuit – this time reversing the Court of Federal Claims ruling that Zoltek’s stealthy patent claims are invalid.
Zoltek is the owner of US Reissue Patent No. Re 34,162[1] issued January 19, 1993. In 1996, Zoltek sued the U.S. government for infringing the patent – in particular, the patentee argued that the B-2 Bomber and F-22 Fighter both used carbon fiber sheets that infringed the patent rights.
As a starting point for most claims against a government is with sovereign immunity. The U.S. Government claims sovereign immunity against suits except where waived. In the patent context, the U.S. government has waived its immunity, but limits the procedure and form of recovery. In particular, 28 U.S.C. § 1498(a) provides that “the owner’s remedy shall be by action against the United States in the United States Court of Federal Claims for the recovery of his reasonable and entire compensation for such use and manufacture.” The statute also provides cover for contractors or other non-government-entities who infringe the patent “with the authorization or consent of the Government” so that those actions must also be pursued against the U.S. Government. The Court of Federal Claims is located in the same Madison Place building as the Court of Appeals for the Federal Circuit.
In its prior en banc decision from the case, the Federal Circuit ruled that Section 1498(a)’s infringement statute should be broadly read to encompass Section 271(g) infringement.
Following that decision, the Court of Federal Claims held a trial on validity and found that the asserted claims were invalid as obvious and/or lacking written description. The court has reversed that holding and remanded.
Omitted Elements: During reissue prosecution of the manufacturing process claims, the applicant deleted the initial step of “oxidizing and stabilizing the carbonizable fiber starting material at an elevated temperature.” That deletion clearly broadened the patent claim – however, a broadening reissue was proper because it had been filed within two years of the grant of the original patent. The CFC found, however, that the new breadth went beyond the original written description and thus rendered the claim invalid – holding that “the preparation of the known starting material must be included in the claim” even if known in the prior art. On appeal, the US Government argued for affimance since “the specification does not state that these steps need not be performed by the same entity.”
On appeal, the Federal Circuit completely rejected this analysis: “The question of who performs steps of a fully described invention, including preparation of a known starting material, is not a matter of the written description requirement.”
The original specification plainly, and without dispute, describes that the starting material is an oxidized and stabilized fiber, cites references showing this known material, and describes its preparation. That a previously oxidized and stabilized starting material was known to a person of ordinary skill in the field was recognized [as well] . . . . The question of who performs steps of a fully described invention, including preparation of a known starting material, is not a matter of the written description requirement.
The purpose of the written description requirement is to assure that the public receives sufficient knowledge of the patented technology, and to demonstrate that the patentee is in possession of the invention claimed. . . . The written description need not include information that is already known and available to the experienced public. . . .
The CFC stated its concern that the reissue patent claims could be infringed by an entity that did not itself make the starting material, but purchased the known starting material from a commercial source. . . . A validly obtained reissue does not violate the written description requirement if the patentee can reach an enlarged scope of possible infringement. It is not an improper broadening amendment when a reissue applicant, with the considered agreement of the reissue Examiner, substitutes a preparatory step known to those skilled in the art at the time of the invention with a requirement to start with the product of that known preparatory step. The CFC’s emphasis on who might infringe the broadened reissue claims is an issue of infringement, not written description. We conclude that the CFC erred in holding reissue claims 1–22 and 33–38 invalid for failure to meet the written description requirement of section 112. That ruling is reversed.
The issue here is definitely interesting – in particular, I see the question of whether the starting-material is available as prior art to be a total red-herring since its manufacture was sufficiently described in the specification. The question is whether the patentee described an invention that began by “obtaining” rather than “making” the starting material. The Federal Circuit didn’t really answer that question. I will note that none of the parties cited Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998) ([not announcing] an omitted essential elements test).
On Obviousness, the Federal Circuit took the government to task as well – finding substantial errors in the Government’s expert testimony and noting the admitted novelty of the fiber sheets created by the inventors. “Instead, the government’s argument appears to be that since [its expert] Dr. Sullivan is a renowned scientist in this field, and since Dr. Sullivan was able to reproduce the Figure 4 graph, it was obvious to do so. This was error.”[2]
Section 101 – The government had also argued that the patented “method of manufacturing . . . carbon fiber sheets” lacked subject matter eligibility under Section 101 as effectively claiming a law of nature. From the CFC Decision rejecting the eligibility argument:
The Government argues that the claims are invalid because they embody nothing more than a law of nature. For example, the Government points to Figure 4 of the patent to support its contention. It argues that Figure 4, which charts a relationship between heat treatment temperature and surface resistance, demonstrates the ineligibility of the ‘162 Patent claims by showing that the claims embody nothing more than a natural law that links temperature to resistance. Relying upon the testimony of its expert, Dr. Brian Sullivan, the Government argues that the independent claims at issue (claims 1 and 33) consist of three parts: (1) the manufacture of carbon fibers using conventional carbonization equipment and techniques; (2) the manufacture of a sheet product using conventional techniques and processes; and (3) “the concept that if you control the fibers’ volume electrical resistivity it gives you the ability to control the sheet or surface resistivity of the final carbon mat productThe Government argues that these three parts render the ‘162 Patent’s claims similar to those found ineligible in Flook and Mayo. . . . The Court agrees with Zoltek [and disagrees with the Government]. The Government’s comparisons to the ineligible claims in Flook and Mayo are much less apt than comparison to Diehr.
The CFC did reject that argument and the Government did not appeal that issue.
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[1] The ‘162 Reissue Patent originally issued in 1988 as U.S. Patent No. 4,728,395 and then reissued in 1993. Zoltek obtained the patent rights when it bought Stackpole Fibers in 1988.
[2] See Uniroyal, Inc. v. Rudkin-Wiley Corp., 837 F.2d 1044, 1051 (Fed. Cir. 1988) (“[t]hat which may be made clear and thus ‘obvious’ to a court, with the invention fully diagrammed and aided . . . by experts in the field, may have been a break-through of substantial dimension when first unveiled.”); see also KSR (“A factfinder should be aware, of course, of the distortion caused by hindsight bias and must be cautious of arguments reliant upon ex post reasoning”); W.L. Gore, 721 F.2d at 1553 (“It is difficult but necessary that the decisionmaker forget what he or she has been taught at trial about the claimed invention and cast the mind back to the time the invention was made (often as here many years), to occupy the mind of one skilled in the art who is presented only with the references, and who is normally guided by the then-accepted wisdom in the art.”).
In discussing the recent ICU Medical case, I noted that Judge Moore’s decision did not rely on the “essential element” test or even cite Gentry Gallery. In Gentry Gallery, the patent covered a sectional recliner. During prosecution, the patentee had amended its claims to drop any reference to the location of the recliner controls. The Federal Circuit held those later-drafted claims invalid because the location of the controls was an “essential element” of the invention that must be included in the claims – otherwise, the claim scope would be unduly broad. Following Gentry Gallery, however, the Federal Circuit stepped-back from the essential element language– instead narrowing the case holding to the well trod notion that claims should be limited to the supporting disclosure. In both Johnson Worldwide, and Cooper Cameron, for instance, the Federal Circuit explicitly denied that Gentry Gallery created any new requirement.
“[W]e did not announce a new ‘essential element’ test mandating an inquiry into what an inventor considers to be essential to his invention and requiring that the claims incorporate those elements.” Cooper Cameron, 291 F.3d 1317 (Fed. Cir. 2002)
In parallel fashion to Gentry Gallery, ICU had included a “spike” in every embodiment and each original claim. During prosecution, and apparently after seeing competing products, ICU amended its claims to drop the “spike” limitation. This was important because the market had moved to a spikeless version of IV valves. This district court in ICU discussed Gentry Gallery and the essential element test, but found no need to base its ruling on that “disfavored” theory. Rather, the court based its analysis on the traditional notion that claims must be described in the specification.
“[T]he Court’s analysis employs the accepted rule that the claims may be no broader than the supporting disclosure, or, conversely, that claims are invalid when the entirety of the specification clearly indicates that the invention is of a much narrower scope. By focusing on the language of the Common Specification in a manner that highlights the function of the “spike” element, and the frequency and ubiquity with which it is referenced, the Court is only attempting to discern the breadth and substance of the invention ICU actually disclosed in the original 1992 Application.”
Although the district court denied its application of any “essential element” test, it went on to hold that any valid claims must include a spike:
“The pervasiveness of the “spike” element in the invention description clearly informs the Court, and would inform any reasonable juror, that what was disclosed and claimed as the invention in the 1992 Application was a needleless medical valve with at a minimum, a “body,” a “seal” and a “spike.””
Likewise, the Federal Circuit’s version denies an omitted element test, but held that any valid claim must include a spike limitation because “a person of skill in the art would not understand the inventor … to have invented a spikeless medical valve.”
ICU Medical v. Alaris Medical System (Fed. Cir. 2009)
This is the second post on the ICU case. Part I discusses the $4.6 million award of attorney fees to the accused infringer based on the patentee’s litigation misconduct.
The district court found several of ICU’s claims invalid for lack of written description under 35 U.S.C. § 112, ¶ 1. On appeal, the Federal Circuit affirmed. (Judges Michel (CJ), Prost, and Moore; Opinion by Moore). Although similar to enablement, the written description requirement pushes an applicant to “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.” Most often, written description arises in cases where new matter is added to the claims during prosecution. That is also the case here – during prosecution ICU amended its claims to include “spikeless” claims — directed to a valve mechanism for adding drugs to an IV without using needles.
To be clear – the original claims included the “spike.” That element was removed during prosecution – seemingly broadening the claims. As the court stated “we refer to these claims as spikeless not because they exclude the preferred embodiment of a valve with a spike but rather because these claims do not include a spike limitation—i.e., they do not require a spike.” It is that failure to include any discussion of a spike in the claim that lead to the claim being held invalid for lack of written description.
The Federal Circuit does not cite Gentry Gallery or the infamous “omitted element” or “essential element” theories. However, the court does rely heavily on LizardTech. In that case, the court did not point to any claim limitation that was not sufficiently described. Rather, the court found the claim invalid because an embodiment arguably covered by the claim was not sufficiently disclosed.
We addressed a similar issue in LizardTech . . . We explained that “the specification provides only one method for creating a seamless DWT, which is to ‘maintain updated sums’ of DWT coefficients. That is the procedure recited by claim 1. Yet claim 21 is broader than claim 1 because it lacks the ‘maintain updated sums’ limitation.” We determined, however, that “[a]fter reading the patent, a person of skill in the art would not understand how to make a seamless DWT generically and would not understand LizardTech to have invented a method for making a seamless DWT, except by ‘maintaining updat[ed] sums of DWT coefficients.'” We therefore concluded that claim 21 was invalid under the written description requirement of § 112, ¶ 1.
In LizardTech, the court explicitly rejected the argument that the written description requirement “requires only that each individual step in a claimed process be described adequately.”
In this case, ICU’s original disclosure focused on spiked embodiments, but the more generic claims are not so limited.
ICU’s asserted spikeless claims are broader than its asserted spike claims because they do not include a spike limitation; these spikeless claims thus refer to medical valves generically—covering those valves that operate with a spike and those that operate without a spike. But the specification describes only medical valves with spikes.
Since all the embodiments included the “spike,” the court concluded that “Based on this disclosure, a person of skill in the art would not understand the inventor … to have invented a spikeless medical valve.”
Invalidity affirmed
Notes:
This case also includes an important discussion of claim differentiation that will be dissected in a later post.
Of course, this case suggests the best patent drafting practice of providing multiple embodiments of each claim element, and considering whether each and every limitation in the broadest original claims are necessary.
ICU broadened its claim by dropping a limitation — did ICU introduce new matter?
In a powerful rhetorical approach, Judge Moore chose to refer to the broad claims as “spikeless claims.” As mentioned, those claims do not include a “spikeless” limitation. Rather, they simply omit a “spike” element. As it turns out more than 99.9% all patent claims issued in 2008 are silent about “spikes,” and under the traditional interpretation of the “comprising” transition – all those claims would literally cover embodiments without spikes. The holding here cannot be that all those claims are invalid. I believe that the holding here is largely a result of the fact that the accused device was in-fact spikeless. Unfortunately, this decision does not provide helpful guidance as to when it will apply. Rather, it appears to simply be an additional vague tool available to defense attorneys.
The court did not mention enablement – since it was easy to remove the needle from a syringe and the disclosure includes a preslit seal that could arguably work with a spikeless syringe. That modification would have been enabled based on the original disclosure.
