Written Description Compliance Requires Lack of Different Inventions Achieved by Claimed and Disclosed Ranges
| April 19, 2024
RAI STRATEGIC HOLDINGS, INC. v. PHILIP MORRIS PRODUCTS S.A
Decided: February 9, 2024
Chen, Stoll, and Cunningham. Opinion by Stoll.
Summary
The CAFC addressed a question of written description compliance where a numerical range set forth in a patent claim is narrower than and encompassed by a disclosed range in the specification. The CAFC found that the written description requirement is met under fact-specific circumstances where substantial evidence indicates that a skilled artisan would see no different inventions resulting from the claimed range and the disclosed range.
Details
RAI appealed a final written decision by the Patent Trial and Appeal Board in a post-grant review (PGR) finding certain claims of RAI’s U.S. Patent No. 10,492,542 (“the ’542 patent”) unpatentable. RAI challenged, among other issues,[1] the Board’s finding that claims 10 and 27 of the ’542 patent lack adequate written description under 35 U.S.C. § 112.
The ’542 patent relates to electrically powered “smoking articles” which, as in e-cigarettes, use an electrical heating element to heat tobacco or like substance to form an inhalable vapor or aerosol. Claims 10 and 27—added by preliminary amendment in the underlying application which is a continuation from a former application having no such claims in the original filing—specify that the heating element has a certain range of length, which is not disclosed verbatim in the specification.
The written description requirement is a question of fact subject to substantial evidence review. The CAFC prefaced the written description analysis with the general threshold for compliance: the disclosure must “reasonably convey[ to a skilled artisan] that the inventor had possession of the claimed subject matter as of the filing date.” The CAFC then discussed precedents finding written description support, or lack thereof, for claimed ranges that are narrower than ranges described in specifications.
Courts finding adequate written description: Wertheim, Blaser, Kolmes[2]
In Wertheim, the parameter at issue was “solids content of the concentrated coffee extract.” The claimed range “between 35% and 60%” was found adequately supported by the specification disclosing a broader range of “25% to 60%” along with specific examples where the parameter was either “36% or 50%.” The Wertheim court held that presence of a clear indication that “the broad described range pertains to a different invention than the narrower (and subsumed) claimed range” (emphasis added) would negate adequacy of written description, whereas absence of such indication would support written description compliance.
Two subsequent courts followed Wertheim. InBlaser, the claimed range of temperature for heating a reaction blend for acylation, “80º to 200º C.” was found adequately supported by the disclosure of a broader range of “between 60º and 200º C.” In Kolmes, the claimed range of wrapping rate for cut-resistant yarn, “8–12 turns per inch,” was found adequately supported by the disclosure of a broader range of “4–12 turns per inch, with 8 turns per inch being preferred.”
Courts finding no adequate written description: Baird, Indivior[3]
Baird involved a patent application which included claims copied from an issued patent for an interference proceeding, i.e., the applicant was not the original author of the copied claims. The parameter at issue was a quench bath temperature in production of stretch-orienting polypropylene. The claimed range was “from about 40[º F] to … about 60 [º F].” While this range was explained in the issued patent as having certain criticality, the applicant’s specification disclosed a broader range of “between 32º F and 176º F,” while silent on the narrower range. Finding lack of adequate support, the Baird court reasoned that the copied claim pertained to a “different” invention from that disclosed in the specification.
In Indivior, the parameter at issue was a concentration of certain polymers in thin film formulation. Disputed claims recited two numerical ranges: (A) “about 40 wt % to about 60 wt %” and (B) “about 48.2 wt % to about 58.6 wt %.” The specification disclosed broader ranges—or lower bounds without express upper bounds—of “at least 25” and “at least 50,” as well as specific instances of “48.2” and “58.6” gleaned from data tables. The specification also stated that the parameter may be at “any desired level.” The claimed range (A) failed the written description requirement because the specification did not literally recite the range or the endpoints, while the “any desired level” statement obscured the scope of the invention. The claimed range (B) also failed the written description requirement because, although the endpoints were disclosed at least implicitly, it was unclear that the specification described the range bound by these endpoints.
Application to Claims 10 and 27 of the ’542 patent
After summarizing the precedents, the CAFC turned to the claims at issue. Claims 10 and 27 both recite that a heating member used in the smoking device has “a length of about 75% to about 85% of a length of the disposable aerosol forming substance.” The specification describes four progressively narrow, nested ranges for the parameter: “about 75% to about 125%,” “about 80% to about 120%,” “about 85% to about 115%,” and “about 90% to about 110%.” The Board’s finding of no written description was driven by the fact that the upper endpoint “85%” of the claimed range does not have a corresponding upper endpoint in any of the disclosed ranges.
The CAFC found that the written description requirement is met. To reach the conclusion, the CAFC centered its analysis on “different invention” test set forth in Wertheim, restating that “[t]he specification need not expressly recite the claimed range to provide written description support.” The factual inquiry looked to specific factors, including:
- Express disclosure in the specification: Although the claimed range itself is not literally disclosed, both of its endpoints are identified as part of the disclosed ranges.
- Predictability and complexity of the invention: Since the smoking device invention relates to a relatively predictable, electro-mechanical field, and the claim language is simple, the level of clarity or details required to satisfy the written description requirement is low.
- Lack of indication that the claimed parameter affects the invention: The specification nowhere indicates that “operability, effectiveness, or any other parameter” of the invention is impacted by changing the claimed parameter.
Based thereon, the CAFC found no “different invention” arising from the claimed range than that disclosed in the specification.
The CAFC distinguished Indivior and Baird relied upon by the Board. Unlike Indivior, the ’542 patent discloses the endpoints and contains no inconsistent statements regarding the range (e.g., that “any desired level” may work); plus the predictability of the electro-mechanical invention is higher than the chemical invention set forth in the Indivior claims. Also, unlike Baird where the claimed range was shown to have criticality over the boarder disclosed range, no evidence was presented in the present case that the broader disclosed range operates differently than the claimed range.
Additionally, the CAFC dismissed an expert testimony offered by Phillip Morris pointing to different center points of the disclosed range (100%) and the claimed range (80%). The expert evidence was not enough to overcome the intrinsic evidence and the case law supporting adequacy of the written description.
Takeaways
This case exemplifies one way in which a court may apply case-by-case analysis of written description compliance. Where the claimed range is narrower than and subsumed in the disclosed range, the “different invention” test may not only examine the express disclosure and the nature of the technology, but also may consider whether varying the parameter inside and outside the claimed range would make any difference.
While the test could be useful in establishing written description support—given that a patent specification typically describes numerical ranges in connection with one general inventive concept—caution should be used in asserting lack of different inventions emanating from different numerical ranges; such admission might be used by an opponent to support obviousness of the claimed range. The dilemma may be avoided, for example, by drafting an original disclosure to describe both commonalities and differences across broad and narrow ranges as well as specific values of a key parameter.
[1] RAI’s other argument challenged the Board’s obviousness finding of other claims of the ’542 patent, which was affirmed by the CAFC on appeal.
[2] In re Wertheim,541 F.2d 257 (C.C.P.A. 1976), In re Blaser, 556 F.2d 534 (C.C.P.A. 1977), and Kolmes v. World Fibers Corp., 107 F.3d 1534 (Fed. Cir. 1997).
[3] In re Baird,348 F.2d 974 (C.C.P.A. 1965), and Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., 18 F.4th 1323 (Fed. Cir. 2021).
CAFC upheld ITC’s ruling under the ‘Infrequently Applied’ Anderson two-step test regarding the enablement of open-ended ranges
| June 8, 2023
FS.com Inc. v. ITC and Corning Optical Corp.
Decided: April 20, 2023
Before Moore, Prost and Hughes. Opinion by Moore.
Summary:
Corning filed a complaint with the ITC alleging FS was violating §337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), (a.k.a ‘unfair import’) by importing high-density fiber optic equipment that infringed several of their patents – U.S. Patent Nos. 9,020,320; 10,444,456; 10,120,153; and 8,712,206. The patents relate to fiber optic technology commonly used in data centers.
The Commission ultimately determined that FS’ importation of the high-density fiber optic equipment violated §337 and issued a general exclusion order prohibiting the importation of infringing high-density fiber optic equipment and components thereof and a cease-and-desist order directed to FS.
Subsequently, FS appealed the Commission’s determination that the claims of the ’320 and ’456 patents are enabled and its claim construction of “a front opening” in the ’206 patent.
ISSUE 1: ENABLEMENT
FS challenges the Commission’s determination that claims 1 and 3 of the ’320 patent and claims 11, 12, 15, 16, and 21 of the ’456 patent are enabled. These claims recite, in part, “a fiber optic connection density of at least ninety-eight (98) fiber optic connections per U space” or “a fiber optic connection of at least one hundred forty-four (144) fiber optic connections per U space.” FS argued these open-ended density ranges are not enabled because the specification only enables up to 144 fiber optic connections per U space.
A patent’s specification must describe the invention and “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 . . . to make and use the same.” 35 U.S.C. § 112(a). To enable, “the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.”
In determining enablement, the Commission applied the two-part standard set forth in Anderson Corp. v. Fiber Composites, LLC, 474 F.3d 1361 (Fed. Cir. 2007):
[O]pen-ended claims are not inherently improper; as for all claims their appropriateness depends on the particular facts of the invention, the disclosure, and the prior art. They may be supported if there is an inherent, albeit not precisely known, upper limit and the specification enables one of skill in the art to approach that limit.
Although the CAFC acknowledged that the Anderson test is infrequently applied, both FS and Corning agreed that the test governed their legal dispute. In applying this standard, the Commission determined the challenged claims were enabled because skilled artisans would understand the claims to have an inherent upper limit and that the specification enables skilled artisans to approach that limit.
The CAFC agreed, understanding the Commission’s opinion as determining there is an inherent upper limit of about 144 connections per U space. See Appellant’s Opening Br. at 51 (“The only potential finding by the Commission of an inherent upper limit to the open-ended claims is approximately 144 connections per 1U space.”). Specifically, that determination was based on the Commission’s finding that skilled artisans would have understood, as of the ’320 and ’456 patent’s shared priority date (August 2008), that densities substantially above 144 connections per U space were technologically infeasible. This was supported by expert testimony.
ISSUE 2: CLAIM CONSTRUCTION
The Commission construed “a front opening” in claim 14 of the ’206 patent as encompassing one or more openings. FS argued the proper construction of “a front opening” is limited to a single front opening and therefore its modules, which contain multiple openings separated by material or dividers, do not infringe claims 22 and 23. The CAFC disagreed.
The CAFC held that, generally, the terms “a” or “an” in a patent claim mean “one or more,” unless the patentee evinces a clear intent to limit “a” or “an” to “one.” 01 Communique Lab’y, Inc. v. LogMeIn, Inc., 687 F.3d 1292, 1297 (Fed. Cir. 2012). The CAFC concluded here that the claim language and written description did not demonstrate a clear intent to depart from this general rule.
Comments:
- Open-end ranges are not automatically improper. If such a range is required/desired during prosecution, apply the two-part standard set forth in Anderson: (1) is there inherent, albeit not precisely known, support for an upper limit and (2) does the specification enables one of skill in the art to approach that limit.
- The terms “a” or “an” in a patent claim remain to mean “one or more,” unless the patentee evinces a clear intent to limit “a” or “an” to “one.”
When does the absence of evidence turn into evidence of absence? The CAFC vacate their prior decision to now hold that there must be evidence that a skilled artisan would understand silence regarding a limitation to necessarily exclude said limitation.
| September 9, 2022
Novartis Pharmaceuticals v. HEC Pharms Co, Ltd, & Accord Health Care et al.
Summary:
HEC petitioned for rehearing of a CAFC prior decision in this case, (21 F 4th 1362 – Fed. Cir. 2022) in which the CAFC affirmed a final judgement of the Delaware district court determining that claims 1 to 6 of US Patent 9,187,405 are not invalid and that HEC infringes them. The CAFC Panel in the prior case was Judges, Moore (dissent) with Linn and O’Malley. Here, Chief Judge Moore with Circuit Judge Hughes (majority herein after) vacate the CAFC’s prior decision holding that the Novartis claims are invalid for inadequate written description pertaining to a negative limitation.
- Background
Novartis owns the ‘405 patents and markets a drug for treating relapsing remitting multiple sclerosis that purportedly practices the patent. HEC filed an ANDA with the FDA seeking approval to market a generic version of the drug. Novartis sued. The Delaware district count found that the claims were not invalid either as anticipated or for inadequate written description of the no-loading-dose or daily dosage limitations. HEC appeals as to the written description issue of the no-loading dose.
Claim 1 at issue recites in part “a daily dosage of 0.5 mg, absent an immediately preceding loading dose regime.” The appeal at hand being related to the underlined negative limitation. A loading dose is a higher-than-normal daily dose.
The Majority go into detail regarding what is required to satisfy the written description, stating that “[F]or negative claim limitations…. there is adequate written description when., for example, “the specification described a reason to exclude the relevant [element]… A reason to exclude an element could be found in ‘statements in the specification expressly listing the disadvantages of using’ that element and alternatives to it…. Silence is generally not disclosure.” The Majority further noted that the negative limitation may not be recited verbatim in the specification, but there “generally must be something in the specification that conveys to a skilled artisan that the inventor intended the exclusion, such as a discussion of disadvantages or alternatives.” However, the Majority further noted that while “a written descriptions silence about a negative claim limitation is a useful and important clue and may often be dispositive, it is possible that the written description requirement may be satisfied when a skilled artisan would understand the specification as inherently disclaiming the negative limitation.”
The district count had found that the negative limitation was supported because the prophetic trial described therein states “initially” giving a daily dose, thus this would inform the skilled artisan that there was no loading dose. The Majority found this interpretation erroneous arguing that because the specification says “Initially patients receive treatment for 2 to 6 months” it is clear this sentence speaks to the initial length of treatment and not the dosage. The Majority believed that one of the two Novartis experts admitted this, and that the contrary testimony by the second Novartis experts was inconsistent with the plain text of the specification and therefore carried no weight.
Next, the Majority discussed the district courts finding that the specifications disclosure of a daily dosage combined with its silence regarding a loading dose would tell a person of skill that loading doses are excluded. However, the Majority countered that a patent is not presumed complete such that things not mentioned are necessarily excluded. The Majority noted that the applicants added the limitation during prosecution to address a prior art rejection arguing that the limitation was “to specify that the [daily dosage] cannot immediately follow a loading dose regiment” and “to further distinguish their claims.” The Majority argued that if reciting “daily dosage” without mentioning a loading dose necessarily excludes said loading dose, there would have been no reason for the applicants to add the limitation.
The Majority noted that the expert testimony focused on where in the specification the patentee would have mentioned a loading dose if they intended a loading dose to be included, but that is not the issue at hand, rather the question is whether the patentee precluded the use of a loading dose. The Majority concluded that there is no evidence that a skilled artisan would understand silence regarding a loading artisan to necessarily exclude a loading dose.
Thus, the Majority vacated their prior decision and reversed the distinct courts judgement that the claims of the ‘405 patent are not invalid.
- Dissent:
Circuit Judge Linn dissented, her opinion being very reminiscent of her opinion in the prior judgment, for which she penned the Majority. CJ Linn stated that the “majority in its analysis employs the heightened standard of “necessary exclusion” against which to assess the district court’s fact findings in this case and uses that standard to conclude that the district court clearly erred.” CJ Linn argued that the central tenet of the written description jurisprudence is that the disclosure must be read from the perspective of a person of skill in the art. Here, CJ Lin argued that the district conducted an objective inquiry into the four corners of the specification and found sufficient written description, while also crediting the expert testimony. In particular, the testimony that one skilled in the art would understand the loading dose to be excluded, and that loading dose regiments have been used in the prior art for treating MS. CJ Linn concluded this is sufficient to show that claim language that precludes the administration of a loading dose is supported.
Take-away:
- When express support for a negative limitation is absent, look for evidence that a skilled artisan would understand the silence regarding the limitation to necessarily exclude said limitation.
- Be mindful of statements made during prosecution as to why an amendment is being made.
Satisfying Written Description When Therapeutic Effectiveness is Claimed
| June 26, 2019
Nuvo Pharmaceuticals v. Dr. Reddy’s Laboratories
Summary
The CAFC reversed and dismissed a holding by the District Court that the claims of the ‘907 and the ‘285 patents had adequate written description regarding the efficacy of an uncoated PPI. The CAFC states that it not necessary to prove that a claimed pharmaceutical compound actually achieves a certain result. However, if the claim recites said result, then there must be sufficient support in the specification. Herein, the claims were held invalid because the therapeutic effectiveness of uncoated PPI, which was recited in the claims, was not supported by the specification.
Details
The use of a non-steroidal anti-inflammatory drug (hereinafter “NSAID”), such as aspirin, can cause gastrointestinal problems, and thus, some patients are prescribed an acid inhibitor, such as proton pump inhibitor (PPI), to be taken with said NSAID. However, even this combination therapy may be problematic. That is, if the PPI has not taken affect before the administration of the NSAID then gastrointestinal problems may still occur.
The U.S. Patent Nos. 6,926,907 (hereinafter “the ‘907 patent”) and 8,557,285 (hereinafter “the ’285 patent”) are directed towards a coordinated release drug formulation comprising an acid inhibitor/PPI and a NSAID. The coordinated release drug allows for an acid inhibitor to work before the release of the NSAID and thereby minimizes potential gastrointestinal problems. The ‘285 patent is a related patent of the ‘907 patent and both share a specification. Claim 1 of the ‘907 patent and claim 1 of the ‘285 patent are presented below:
Claim 1 of the ’907 patent:
1. A pharmaceutical composition in unit dosage form suitable for oral administration to a patient, comprising:
(a) an acid inhibitor present in an amount effective to raise the gastric pH of said patient to at least 3.5 upon the administration of one or more of said unit dosage forms;
(b) a non-steroidal anti-inflammatory drug (NSAID) in an amount effective to reduce or eliminate pain or inflammation in said patient upon administration of one or more of said unit dosage forms;
and wherein said unit dosage form provides for coordinated release such that:
i) said NSAID is surrounded by a coating that, upon ingestion of said unit dosage form by said patient, prevents the release of essentially any NSAID from said dosage form unless the pH of the surrounding medium is 3.5 or higher;
ii) at least a portion of said acid inhibitor is not surrounded by an enteric coating and, upon ingestion of said unit dosage form by said patient, is released regardless of whether the pH of the surrounding medium is below 3.5 or above 3.5.
(emphasis added)
Claim 1 of the ’285 patent:
1. A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of:
(a) esomeprazole, wherein at least a portion of said esomeprazole is not surrounded by an enteric coating; and
(b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher;
wherein said unit dosage form provides for release of said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium.
(emphasis added)
Nuvo, who owns the ‘907 and ‘285 patents, make and sells Vimovo, which is the commercial embodiment of the patents. The patented drug achieves a coordinated release of the acid inhibitor and the NSAID in a single tablet. The core of the tablet is NSAID, which is coated so as to prevent its release before the pH has increased to a desired level, and an acid inhibitor, like PPI, on the outside of the coating, that actively works to increase the pH to said desired level. The PPI is uncoated. The specifications discloses methods for preparing and making the claimed drug formulations and provides examples of the structure and ingredients of the drug formulations but does not disclose any experimental data demonstrating the therapeutic effectiveness of any amount of uncoated PPI and coated NSAID in a single dosage form. Id. at 6. The specification discloses that coated PPIs avoid destruction by stomach acid but may not work quickly enough and the specification does not have any disclosure regarding the effectiveness of uncoated PPIs being able to raise pH. The inventor of the ‘907 and ‘285 patents recognized that an uncoated PPI is at greater risk of being destroyed by stomach acid, which would undermine the effectiveness of the PPI, but contemplated that uncoated PPI would allow for immediate release into a patient’s stomach and achieve an increase in pH level.
Dr. Reddy’s Laboratories, Inc., Mylan Pharmaceuticals, and Lupin Pharmaceuticals (hereinafter “the Generics”) submitted an Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration seeking approval to sell a generic version of Vimovo. Dr. Reddy’s submitted a second ANDA wherein the product would contain a small amount of uncoated NSAID on the outermost layer of the tablet, which is separate from the coated-core-NSAID.
Nuvo sued the Generics in the U.S. District Court for the District of New Jersey, in order to prevent the Generics from entering the market upon approval of the ANDAs, alleging all ANDAs products would infringe the ‘907 and ‘285 patents. The Generics stipulated to infringement, except for Dr. Reddy’s second ANDA product, and then countered that the ‘907 and ‘285 patents were invalid for obviousness, lack of enablement and inadequate written description.
The District Court granted Dr. Reddy’s motion for summary judgment of noninfringment of the ‘907 patent with regards to the second ANDA product. A bench trail was held regarding the validity of the ‘907 patent, the ‘285 patent, and whether the second ANDA product by Dr. Reddy infringed the ‘285 patent. It was concluded that the claims were not obvious over the prior art “because it was nonobvious to use a PPI to prevent NSAID-related gastric injury, and persons of ordinary skill in the art were discouraged by the prior art from using uncoated PPI and would not have reasonably expected it to work.” Id. at 8. It was also held that the claims of both patents were enabled and there was sufficient written description. The District Court held that the second ANDA by Dr. Reddy infringes the claims of the ‘285 patent.
At the District Court, the Generics argued that, “if they lose on their obviousness contention, then the claims lack written description support for the claimed effectiveness of uncoated PPI because ordinarily skilled artisans would not have expected it to work and the specification provides no experimental data or analytical reasoning showing the inventor possessed an effective uncoated PPI.” Id. at 9. Nuvo countered that “experimental data and an explanation of why an invention works are not required, the specification adequately describes using uncoated PPI, and its effectiveness is necessarily inherent in the described formulation.” Id. at 9. The District Court rejected Nuvo’s argument that effectiveness does not need to be described because effectiveness is inherent. The District Court acknowledged that the specification of the ‘907 and ‘285 patents did not describe efficacy of uncoated PPI. However, the District Court did conclude that there was sufficient written description because “the specification described the immediate release of uncoated PPI and the potential disadvantages of coated PPI, namely that enteric-coated PPI sometimes works too slowly to raise the intragastric pH. The district court did not explain why the mere disclosure of immediate release uncoated PPI, coupled with the known disadvantages of coated PPI, is relevant to the therapeutic effectiveness of uncoated PPI, which the patent itself recognized as problematic for efficacy due to its potential for destruction by stomach acid.” Id. at 10. The Generics appeal the written description ruling and Nuvo cross-appeals the District Court grant of summary judgment of noninfringement. Based solely on the written description issue regarding the claim language of “efficacy”, the CAFC reversed the appeal and dismissed the cross-appeal.
Before the CAFC, the Generics argued that the patents claim uncoated PPI that raises the gastric pH to at least 3.5, but that in view of the District Court’s holding, as part of the obviousness analysis, a skilled artisan would not have expected uncoated PPI to be effective to raise gastric pH, and that the specification of the patents fails to disclose the effectiveness of uncoated PPI. Id. at 12. Nuvo argued that “the claims do not require any particular degree of efficacy of the uncoated PPI itself, it is enough that the specification discloses making and using drug formulations containing effective amounts of PPI and NSAID, and experimental data and additional explanations demonstrating the invention works are unnecessary.” Id. at 12. The CAFC held that the District Court’s analysis does not support its conclusion of adequate written description and gave a review of the record to establish that the clear error standard has been met. “A written description finding is review for a clear error.” Id. at 11.
First, the CACF rejected Nuvo’s argument that the claims do not recite an efficacy requirement for uncoated PPI. As noted above, claim 1 of the ‘907 patent discloses “an acid inhibitor present in an amount effective to raise the gastric pH of said patient to at least 3.5” and claim 1 of the ‘285 patent discloses “therapeutically effective amounts of (a) esomeprazole….” The CAFC held that the claims of both patents require an amount of uncoated PPI effective to raise the gastric pH to at least 3.5. Id. at 14. Further, the CAFC noted that Nuvo’s argument, which is an attempt to “either recharacterizing the written description dispute or rewriting the claim language”, is being presented for the first time on appeal and is thus forfeited. The CAFC held that, before the District Court, the parties characterized that “claims require a therapeutically effective amount of uncoated PPI that would raise the gastric pH to at least 3.5”, that this understanding was “a fair reading of the claim language” and this understanding will not be altered in the appeal. Id. at 16.
Next, Nuvo argued that the expert testimony of Dr. Williams identified four portions of the specification that provided written description support. The Generics argued that the noted portions only disclose typical dosage amounts of uncoated PPI, the use of uncoated PPI in a drug formulation and did not discuss or explain efficacy of uncoated PPI. The CAFC agreed with the Generics. “We have expressly rejected the “argument that the written description requirement … is necessarily met as a matter of law because the claim language appears in ipsis verbis in the specification.” Enzo Biochem, Inc. v. GenProbe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002).” Id. at 18. The CAFC noted that the case law does not requirement experimental data to establish effectiveness or an explanation of how or why a claimed composition will be effective. Id. at 18. Nevertheless, the CAFC held that the “record evidence demonstrates that a person of ordinary skill in the art would not have known or understood that uncoated PPI is effective.” Id. at 18. The CAFC held that the specification is fatally flawed since the “the specification provides nothing more than the mere claim that uncoated PPI might work, even though persons of ordinary skill in the art would not have thought it would work…. It does not demonstrate that the inventor possessed more than a mere wish or hope that uncoated PPI would work, and thus it does not demonstrate that he actually invented what he claimed: an amount of uncoated PPI that is effective to raise the gastric pH to at least 3.5” Id. at 19. The inventor’s own testimony confirms this holding. At trial, the inventor admitted “that he only had a ‘general concept of coordinated delivery with acid inhibition’ using uncoated PPI at the time he filed his first patent application.” Id. at 19.
Lastly, Nuvo argued that the written description requirement was satisfied due to the disclosure of how to make and use the claimed invention and accept that therapeutic effectiveness of uncoated PPI is a matter of inherency. Id. at 20 and 21. The Generics argued that Nuvo’s assertion did not satisfy written description but would only satisfy the enablement requirement, which is a separate and distinct requirement. Nuvo cited Alcon Research Ltd. v. Barr Laboratories, Inc., 745 F.3d 1180 (Fed. Cir. 2014) for support but the CAFC quickly dismissed this and noted that the factual circumstances of Alcon were “markedly different”. Id. at 22. In Alcon, the patent reference presented example formulations and disclosed data showing stability testing of the claimed invention. Further, the CAFC stated that only “under a narrow set circumstance” would inherency satisfy the written description requirement. Nuvo cited Allergan to support their argument that the claimed efficacy of uncoated PPI is necessarily inherent in the specification’s explicit disclosure of methods for making and using drug formulations containing uncoated PPI. The CAFC agreed with the Generics that the factual circumstances of Allergan are not applicable to the present case. In Allergan, the parties did not dispute the therapeutic efficacy of the claimed formulation and the specification in Allergan presented experimental results that established a trend in clinical effectiveness.
Based on the specific facts of certain cases, it is unnecessary to prove that a claimed pharmaceutical compound actually achieves a certain result. But when the inventor expressly claims that result, our case law provides that that result must be supported by adequate disclosure in the specification. In this case, the inventor chose to claim the therapeutic effectiveness of uncoated PPI, but he did not adequately describe the efficacy of uncoated PPI so as to demonstrate to ordinarily skilled artisans that he possessed and actually invented what he claimed. And the evidence demonstrates that a person of ordinary skill in the art reading the specification would not have otherwise recognized, based on the disclosure of a formulation containing uncoated PPI, that it would be efficacious because he or she would not have expected uncoated PPI to raise gastric pH. Under those facts, the patent claims are invalid for lack of adequate written description pursuant to § 112, ¶ 1.
(emphasis added). Id. at 24.
The CAFC holds that the ‘907 patent and the ‘285 patent invalid for lack of adequate written description with regards to the claimed effectiveness of uncoated PPI. The CAFC did not address the other issues on appeal and cross-appeal.
Takeaway
- Before
filing an application, one may consider identifying the written description support
in the specification for each individual feature of a claim
- Given the narrow set of circumstances, try not to rely upon inherency to satisfy written description
- If possible, include experimental data of drug formulations
A Patent of Few Words and a Defendant with a Few Parts cannot avoid a Trier of Fact
| February 22, 2019
Centrak, Inc. v. Sonitor Tech., Inc.
February 14, 2019
Before Reyna, Taranto and Chen. Opinion by Chen.
Summary:
The CAFC reversed and remanded a Motion of Summary Judgment finding that the District Court errored in focusing on the length of a written description and dismissing a plausible theory for direct infringement based on the final assembly being done by the defendant within a customer’s system.
Details
- Background
CenTrak, Inc. sued Sonitor Technologies, Inc. for alleged infringement of U.S. Patent No. 8,604,909 (’909 patent), which claims systems for locating and identifying portable devices using ultrasonic base stations. The district court granted Sonitor’s MSJ that the relevant claims are invalid for lack of written description and are not directly infringed because Sonitor does not individually provide for all the aspects of the claims.
The claims are directed to ultrasonic base stations which can be mounted in various fixed locations in a facility, such as rooms in a hospital, and the portable devices can be attached to people or assets that move between rooms. Each portable device is configured to detect the ultrasonic location codes from the nearby ultrasonic base stations and “transmit an output signal including a portable device ID representative of the portable device and the detected ultrasonic location code.” While the portable devices receive location codes from ultrasonic base stations via ultrasound, they might transmit location and device information via RF to an RF base station.
The asserted claims generally recite: (1) ultrasonic (US) base stations; (2) portable devices (tags); (3) a server; (4) radio frequency (RF) base stations; and (5) a backbone network that connects the server with the RF base stations.
All the claims of the ’909 patent are directed to “ultrasonic” components. However, the specification focuses on infrared (IR) or RF components. Only two sentences of the ’909 patent’s specification discuss ultrasonic technology:
Although IR base stations 106 are described, it is contemplated that the base stations 106 may also be configured to transmit a corresponding BS-ID by an ultrasonic signal, such that base stations 106 may represent ultrasonic base stations. Accordingly, portable devices 108 may be configured to include an ultrasonic receiver to receive the BS-ID from an ultrasonic base station.
In regard to lack of written description, Sonitor argued that the two sentences in the specification dedicated to ultrasound, did not show that the inventors had possession of an ultrasound-based RTL system.
Regarding invalidity, the district court ruled that while the specification “contemplated” ultrasound, “[m]ere contemplation . . . is not sufficient to meet the written description requirement.
In regard to infringement, the accused Sonitor Sense system includes three pieces of hardware sold by Sonitor: RF “gateways,” ultrasonic location transmitters, and portable locator tags. Sonitor also provides software for installation on a customer’s server hardware.
Sonitor’s main non-infringement argument was that Sonitor does not make, use, or sell certain elements recited in the claims, including the required backbone network, Wi-Fi access points, or server hardware.
CenTrak argues that the resulting system infringes the ’909 patent when the components Sonitor sells are integrated with a customer’s existing network and server hardware. CenTrak asserted only direct infringement. Since, Sonitor does not sell all of the hardware necessary to practice the asserted claims, so, on appeal, CenTrak only pursued a theory under 35 U.S.C. § 271(a) that Sonitor “makes” infringing systems when it installs and configures the Sonitor Sense system. In short, the crux of CenTrak’s assertion is that there is direct infringement when the party assembles components into the claimed assembly (i.e. the party “makes” the patented invention, even when someone else supplies most of the components).
The district court granted summary judgment of non-infringement. It held that a defendant must be the actor who assembles the entire claimed system to be liable for direct infringement, and CenTrak had not submitted proof that Sonitor personnel had made an infringing assembly.
CenTrak appealed both MSJ grants.
2. Opinion
In regard to invalidity, the CAFC held that, the district court leaned too heavily on the fact that the specification devoted relatively less attention to the ultra-sonic embodiment compared to the infrared embodiment. Quoting their ScriptPro LLC v. Innovation Associates, Inc., 833 F.3d 1336, 1341 (Fed. Cir. 2016), they reiterated that “a specification’s focus on one particular embodiment or purpose cannot limit the described invention where that specification expressly contemplates other embodiments or purposes.”
The Court explained that the real question is the level of detail the ’909 patent’s specification must contain, beyond disclosing that ultrasonic signals can be used, to adequately convey to a skilled artisan that the inventors possessed an ultrasonic embodiment. Citing their Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) en banc: “the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” They further noted per Ariad that the issue of whether a claimed invention satisfies the written description requirement is a question of fact.
The opinion details that the parties disputed the complexity and predictability of ultrasonic RTL systems, and the district court erred at the summary judgment stage by not sufficiently crediting testimony from CenTrak’s expert that the differences between IR and ultrasound, when used to transmit small amounts of data over short distances, are incidental to carrying out the claimed invention. The Court specifically noted the testimony from CenTrak’s expert that those details were not particularly complex or unpredictable, and Sonitor does not explain why a person of ordinary skill in the art would need to see such details in the specification to find that the named inventors actually invented the claimed system.
Hence, the Court concluded that:
…there is a material dispute of fact as to whether the named inventors actually possessed an ultrasonic RTL system at the time they filed their patent application or whether they were “leaving it to the . . . industry to complete an unfinished invention.”…
Here, as in ScriptPro, the fact that the bulk of the specification discusses a system with infrared components does not necessarily mean that the inventors did not also constructively reduce to practice a system with ultrasonic components … “the written description requirement does not demand either examples or an actual reduction to practice; a constructive reduction to practice” may be sufficient if it “identifies the claimed invention” and does so “in a definite way.” Ariad, 598 F.3d at 1352.
In regard to direct infringement, the Court noted that it is undisputed that Sonitor does not provide certain claimed elements in the accused systems, such as a backbone network, Wi-Fi access points, or server hardware. Moreover, the district court analyzed the evidence CenTrak offered and concluded that no reasonable jury could find that Sonitor “made” the claimed invention by performing installations relying on Centillion Data Systems, LLC v. Qwest Communications International, Inc., 631 F.3d 1279 (Fed. Cir. 2011) for the proposition that to “make” a system, a single entity must assemble the entire system itself.
The CAFC found that Centillion does not rule out CenTrak’s infringement theory. In this case, Cen-Trak argued that the final, missing elements are the configuration that allows the location transmitters to work with the network and the location codes that are entered into the Sonitor server. According to CenTrak, admissible evidence that Sonitor is the “final assembler” raises a triable issue of fact on infringement even though Sonitor does not “make” each of the claimed components of the accused systems.
The Court further held that under Lifetime Industries, Inc. v. Trim-Lok, Inc., 869 F.3d 1372 (Fed. Cir. 2017), and Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1311 (Fed. Cir. 2005), a final assembler can be liable for making an infringing combination—assuming the evidence supports such a finding—even if it does not make each individual component element.
3. Decision
The CAFC found that the District Court errored in both: (1) finding a lack of written description as it relied too heavily on the briefness of the ‘909 patents comments on ultrasonic RTL systems rather than the amount of knowledge needed for a skilled artisan to consider; and (2) finding that there was no dispute of fact as to whether Sonitor was a “final assembler” by virtue of performing the final system installation for its customers. The Court therefore reversed and remanded.
Take away
- The measure of a sufficient written description is not in its length. Rather, the test is to the amount of disclosure necessary for a skilled artisan to discern that the inventor in fact possessed the invention.
- A case for direct infringement can be made even where the defendant does not “make all the parts” if there is sufficient evidence that the accused infringer is a “final assembler” in terms of actuating the combination of elements to infringe.
Tags: 35 U.S.C. §112 > direct infringement > summary judgment > written description
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。
Tags: drawings > expert declaration > Inter Partes Reexamination > PCT application > priority > written description
CAFC looks to complete disclosure of patent at issue and its related patents to counter patent owner’s arguments based on cherry-picking.
| February 8, 2018
Paice LLC v. Ford Motor Company
February 1, 2018
Before Lourie, O’Malley, and Taranto. Opinion by O’Malley
Summary
Due to error in the PTAB’s interpretation of incorporation by reference, the CAFC vacated the PTAB’s obviousness determination with respect to claims that relied on the incorporation by reference for their written description, and found substantial evidence to affirm the PTAB’s findings of obviousness of all other claims.
Tags: claim construction > Incorporation by reference > obviousness > written description
When is Evidence of Written Description Too Late?
| October 24, 2017
Amgen v. Sanofi
October 5, 2017
Before Prost, Taranto and Hughes. Opinion by Judge Prost.
Procedural History:
The two patents-in-suit disclose and claim a set of antibodies. The following claim is representative:
An isolated monoclonal antibody,
wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and
wherein the monoclonal antibody blocks binding of PCSK9 to LDL[-]R.
The technical background of the invention involves statins that are administered to patients to reduce high levels of LDL-C in the blood. When these statins do not work, doctors sometimes administer PCSF9 inhibitor as well – PCSK9 being a naturally occurring protein that binds to and destroys liver cell LDL-receptors that take LDL-C from the blood.
The claim recites a genus of antibodies that bind to PCSK9 at the recited residue sites, thereby preventing PCSK9 from interfering with LDL-C removal from the blood.
The specification, common to both patents, discloses “85 antibodies that blocked interaction between the PCSK9 . . . and the LDLR [at] greater than 90%,” It also discloses the three-dimensional structures, obtained via x-ray crystallography, of two antibodies known to bind to residues recited in the claims—21B12 (Repatha) and 31H4.
Appellant/Defendant Sanofi markets an antibody named Praluent® alirocumab. Appellee/Patentee sued Sanofi for patent infringement. Sanofi replied, inter alia, that the claims did not comply with the written description and enablement requirements.
In a jury trial, the judge excluded from the evidentiary record all post-priority-date information that Sanofi proffered to show that the written description and enablement requirements were not met. Specifically, Sanofi’s proffered evidence that included its own later-developed Praluent product that was developed after the priority date of Amgen’s patents.
Ultimately, the jury issued a verdict that the patents were valid and infringed.
The CAFC reversed the trial judge’s exclusionary ruling and vacated the jury’s verdict. It first set forth the legal background, specifically, that a patentee must convey in its disclosure that it “had possession of the claimed subject matter as of the filing date” and that to provide this “precise definition” for a claim to a genus, a patentee must disclose “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” (Emphasis added).
Here, Sanofi’s evidence regarding Praluent was relevant to the material issue of whether the two patents disclosed a representative number of species within the claimed genus. The CAFC therefore held that the trial judge erred in excluding Sanofi’s evidence and ordered a new trial on written description. It also ordered a new trial on enablement for the same reasons.
The CAFC summarized the legal basis for its holding: evidence that explains the state of the art after the priority date is not relevant to written description. On the other hand, where a patent claims a genus, it must disclose “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Accordingly, evidence showing that a claimed genus does not disclose a representative number of species may include evidence of species that fall within the claimed genus but are not disclosed by the patent, and evidence of such species is likely to postdate the priority date.
Take Away
The lesson is that the purpose for which post-priority date evidence is proffered determines whether it is admissible.
A diagnostic method that raises, not patent-eligibility, but written description issues.
| July 24, 2017
Stanford Univ. v. The Chinese Univ. of Hong Kong (Precedential)
June 27, 2017
Before O’Malley, Reyna, and Chen. Opinion by O’Malley.
Summary:
In interferences involving a patent by Stanford and applications by the Chinese University of Hong Kong, the USPTO found the Stanford patent’s claims unpatentable as lacking written description. The Federal Circuit vacated and remanded. The USPTO was faulted for relying on post-filing date information as evidence of what the person of the art knew at the filing date.
Of Closed Pods, Open Cartridges, Single-Brew Coffee Machines, and Descriptive Issues
| June 5, 2017
Rivera v. ITC (Precedential)
May 23, 2017
Before Reyna, Linn and Chen. Opinion by Linn.
Summary:
The Federal Circuit affirmed an ITC decision that the asserted patent claims are invalid for lack of written description. The patent application as filed described only a coffee machine with a cartridge adapter configured to receive a closed “pod”, not a cartridge adapter with an open filter for ground coffee. Thus, the written description did not show possession by the inventors of a genus encompassing the open-filter cartridge adapters at the initial filing date.
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