Patent Term Extension under 35 U.S.C. §156 is Limited to the FDA-Approved Active Ingredient and Salts or Esters thereof—but not Metabolites or Compounds Sharing an Active Moiety
WHDA Blogging Team | May 13, 2020
Biogen International GmbH v. Banner Life Sciences
April 21, 2020
Lourie, Moore, and Chen. Opinion by Lourie
Summary
In a case focusing on the meaning of a “product” under 35 U.S.C. §156, the CAFC concluded that the scope of patent term extension is limited to the FDA-approved active ingredient and salts or ester thereof, and does not more broadly include metabolites or other compounds sharing an active moiety with the approved product. Thus, the extension of Biogen’s ‘001 patent does not include some other products within the scope of the claims, such as the metabolite MMF.
Details
Background and District Court holding
Biogen is the owner of U.S. Patent No. 7,619,001, which claims a method of treating multiple sclerosis. Claim 1 is as follows:
A method of treating multiple sclerosis comprising administering, to a patient in need of treatment for multiple sclerosis, an amount of a pharmaceutical preparation effective for treating multiple sclerosis, the pharmaceutical preparation comprising
at least one excipient or at least one carrier or at least one combination thereof; and
dimethyl fumarate, methyl hydrogen fumarate, or a combination thereof.
Biogen also holds the New Drug Application (NDA) for dimethyl fumarate (DMF). This was approved by the FDA in 2013 and is marketed as Tecfidera® “for the treatment of patients with relapsing forms of multiple sclerosis” at a dose of 480 mg.
DMF is a double ester which, upon administration to the patient, metabolizes into monomethyl fumarate (MMF) (another name for the claimed “methyl hydrogen fumarate”). Both DMF and MMF are illustrated below.
The ‘001 patent is was originally set to expire on April 1, 2018, but was awarded 818 days of patent term extension to June 20, 2020 under 35 U.S.C. 156 (not to be confused with patent term adjustment under 35 U.S.C. 154). This compensated Biogen for the FDA review period of Tecfidera. The question presented to the CAFC is whether MMF is covered by the 818-day PTE extension along with DMF.
In 2018, Banner filed a “paper NDA” under 21 U.S.C. 355(b)(2) to market a drug having MMF as the active ingredient. Banner could rely on Biogen’s clinical data to show safety and efficacy, and only had to demonstrate bioequivalence. Biogen then sued Banner for infringement.
In reply, Banner argued that the PTE under §156 was limited to uses including the approved product: DMF and its salts or esters, and did not include MMF. The relevant portions of §156 are presented below:
(a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section from the original expiration date of the patent, which shall include any patent term adjustment granted under section 154(b),…
(b) Except as provided in subsection (d)(5)(F), the rights derived from any patent the term of which is extended under this section shall during the period during which the term of the patent is extended—….
(2) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent and approved for the product—
(A) before the expiration of the term of the patent—
(i) under any provision of law under which an applicable regulatory review occurred, and
(ii) under the provision of law under which any regulatory review described in paragraph (1), (4), or (5) of subsection (g) occurred, and
(B) on or after the expiration of the regulatory review period upon which the extension of the patent was based; and….
(f) For purposes of this section:
(1) The term “product” means:
(A) A drug product…..
(2) The term “drug product” means the active ingredient of—
(A) a new drug, antibiotic drug, or human biological product…including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.
Meanwhile, Biogen argued that §156(b)(2) does not limit the PTE to uses of the approved product, but rather to all products within the scope of the claim. Additionally, Biogen argued that “product” of §156 should be more broadly interpreted as any compound that shares the “active moiety” with the approved product. The district court sided with Banner.
CAFC
First, the CAFC noted that the purpose of §156 PTE is to compensate a patent owner for regulatory delays, and that this is limited to one patent per approved product. The court also noted that §156 defines the scope of the product as “the active ingredient of…a new drug…including any salt or ester of the active ingredient.”
Biogen cited Pfizer Inc. v. Dr. Reddy’s Labs, Ltd. 359 F.3d 1361 (Fed. Cir. 2004) to support the position that that “product” under §156 should be interpreted more broadly, especially where “a later applicant’s patentably indistinct drug product…relies on the patentee’s clinical data.” The CAFC did not accept this argument. In Pfizer, the question was whether an extension for amlodipine included amlodipine maleate. However, the CAFC concluded that amlodipine maleate in Pfizer was included under the extension because amlodipine maleate is a salt of the active ingredient (amlodipine), and not because these two compounds share an “active moiety.” On the other hand, in this case, MMF is not a salt or ester of DMF. Rather, MMF is a de-esterified form of DMF. The CAFC’s comments regarding clinical data were provided in Pfizer merely to clarify the purpose of §156(f) and provide context.
The parties also cited to Glaxo Ops. UK Ltd. v. Quigg, 894 F.2d 392 (Fed. Cir. 1990). However, the CAFC concluded that this case was not pertinent to the present issue. Glaxo involved an approved product having cerufoxime as its active ingredient and a second approved product having cerufoxime axetil as its active ingredient, cerufoxime axetil being an ester of cerufoxime. In Glaxo, the question was not whether cerufoxime axetil should be included in an extension for cerufoxime, but rather whether cerufoxime axetil was eligible for its own separate PTE. Since this is not the issue in the present case, the CAFC side-stepped Glaxo.
Additionally, Biogen cited to PhotoCure ASA v. Kappos, 603 F.3d 1372 (Fed. Cir. 2004). In PhotoCure, the CAFC indicated that a new ester could be separately patentable. However, the CAFC indicated that PhotoCure presented a similar situation as Glaxo: a separate extension for a new ester.
Thus, the CAFC held that the definition of “product” according to §156 is the “active ingredient ….including any salt or ester of the active ingredient.” This is not necessarily the same as “active moiety.” As such, “product” only means the active ingredient designated on the FDA approved label, and changes resulting in a salt or ester. However, “product” does not include metabolites of the active ingredient, or de-esterified forms thereof. Here, MMF is a de-esterified metabolite of DMF, rather than a salt of DMF.
Next, Biogen argued that, unlike §156(b)(1), §156(b)(2) does not limit the extension to approved uses of the approved product, but only to approved uses of any approved product. However, the CAFC dismissed this by holding that the approved product in this case is DMF, not MMF, and that it would not make sense for an extension to apply to a different product for which the NDA holder was never subjected to review.
Finally, Biogen argued that the Banner infringes under the doctrine of the equivalents. However, the CAFC dismissed this argument on that basis that a product or process cannot logically infringe an extended claim under equivalents if it is statutorily not included in the §156 extension.
Take Away
Unlike patent term adjustment under §154, which covers the full scope of the patent, patent term extension under §156 is limited in scope to a product having the active ingredient granted regulatory approval by the FDA. The “product” will be narrowly interpreted as the approved active ingredient, as well as salts and esters thereof. As such, patent term extension under §156 is not so broad to cover metabolites and other compounds which share an active moiety with the approved drug.
Interestingly, this case was decided near in time to an important IPR involving the same drug. In February, the PTAB sided with Biogen in a challenge to U.S. Patent No. 8,399,514 by Mylan Pharmaceuticals. The ‘514 patent was very similar to the claims of the ‘001 patent, but recited oral administration and a specific dosage. The PTAB indicated that the dosage was not obvious from the prior art and thus confirmed the validity of the valuable ‘514 patent. The ‘514 patent is the last unexpired patent in the family covering Tecfidera, and is set to expire in 2028.
Additionally, upon the CAFC’s decision, the FDA granted final approval on April 30 to Banner’s MMF-based drug, which will be marketed as Bafiertam ®.
The Federal Circuit declined to be bound by the 2019 Revised Patent Subject Matter Eligibility Guidance by the Patent Office, but affirmed the Board’s conclusion of the ineligibility, which relied on the Guidance
WHDA Blogging Team | May 7, 2020
In re Rudy
April 24, 2020
Prost, Chief Judge, O’Malley and Taranto. Court opinion by Prost.
Summary
The Federal Circuit declined to be bound by the 2019 Revised Patent Subject Matter Eligibility Guidance by the Patent Office, and instead followed the Supreme Court’s Alice/Mayo framework, and the Federal Circuit’s interpretation and application thereof. However, the Federal Circuit unanimously affirmed the Board’ affirmance of the Examiner’s rejection of claims 34, 35, 37, 38, 40, and 45–49 of the ’360 application as patent-ineligible under 35 U.S.C. § 101, which was fully relied on the Office Guidance.
Details
I. background
United States Patent Application No. 07/425,360 (“the ’360 application”), filed by Christopher Rudy on October 21, 1989 (before the signing of the 1994 Uruguay Round Agreements Act), is entitled “Eyeless, Knotless, Colorable and/or Translucent/Transparent Fishing Hooks with Associatable Apparatus and Methods.” After a lengthy prosecution of more than twenty years, including numerous amendments and petitions, four Board appeals, and a previous trip to the Federal Circuit where the obviousness of all claims then on appeal was affirmed (In re Rudy, 558 F. App’x. 1011 (Fed. Cir. 2014) (non-precedential)), claim 34, which the Board considered illustrative, reads as follows:
34. A method for fishing comprising steps of
(1) observing clarity of water to be fished to deter- mine whether the water is clear, stained, or muddy,
(2) measuring light transmittance at a depth in the water where a fishing hook is to be placed, and then
(3) selecting a colored or colorless quality of the fishing hook to be used by matching the observed water conditions ((1) and (2)) with a color or colorless quality which has been previously determined to be less attractive under said conditions than has undergone those pointed out by the following correlation for fish-attractive non-fluorescent colors:
The Patent Trial and Appeal Board (“Board”) affirmed the Examiner’s rejection of claims 34, 35, 37, 38, 40, and 45–49 of the ’360 application in the last Board appeal. The Board conducted its analysis under a dual framework for patent eligibility, purporting to apply both 1) “the two-step framework described in Mayo [Collaborative Ser- vices v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012)] and Alice [Corp. v. CLS Bank International, 573 U.S. 208 (2014)],” and 2) the 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Office Guidance”), published by the United States Patent and Trademark Office (“Patent Office”). Specifically, the Board concluded “[u]nder the first step of the Alice/Mayo framework and Step 2A, Prong 1, of [the] Office Guidelines” that claim 34 is directed to the abstract idea of “select[ing] a colored or colorless quality of a fishing hook based on observed and measured water conditions, which is a concept performed in the human mind.” The Board went on to conclude that “[u]nder the second step in the Alice/Mayo framework, and Step 2B of the 2019 Revised Guidance, we determine that the claim limitations, taken individually or as an ordered combination, do not amount to significantly more than” the abstract idea.
Mr. Rudy timely appealed, challenging both the Board’s reliance on the Office Guidance, and the Board’s ultimate conclusion that the claims are not patent eligible.
II. The Federal Circuit
The Federal Circuit unanimously affirmed the Board’ affirmance of the Examiner’s rejection of claims 34, 35, 37, 38, 40, and 45–49 of the ’360 application.
1. Office Guidance vs. Case Law
Mr. Rudy contended that the Board “misapplied or refused to apply . . . case law” in its subject matter eligibility analysis and committed legal error by instead applying the Office Guidance “as if it were prevailing law.”
The Federal Circuit agreed with Mr. Rudy, stating: “[w]e are not[] bound by the Office Guidance, which cannot modify or supplant the Supreme Court’s law regarding patent eligibility, or our interpretation and application thereof.” Interestingly, the Federal cited a non-precedential opinion to support its position: “As we have previously explained:
While we greatly respect the PTO’s expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance. And, especially regarding the issue of patent eligibility and the efforts of the courts to determine the distinction between claims directed to [judicial exceptions] and those directed to patent-eligible ap- plications of those [exceptions], we are mindful of the need for consistent application of our case law.
Cleveland Clinic Found. v. True Health Diagnostics LLC, 760 F. App’x. 1013, 1020 (Fed. Cir. 2019) (non-precedential). ”
In conclusion, the Federal Circuit declared: “[t]o the extent the Office Guidance contradicts or does not fully accord with our caselaw, it is our caselaw, and the Supreme Court precedent it is based upon, that must control.”
2. Subject Matter Eligibility of Rudy’s Case
The Federal Circuit concluded that although a portion of the Board’s analysis is framed as a recitation of the Office Guidance, the Board’s reasoning and conclusion for Rudy’s case are nevertheless fully in accord with the relevant caselaw in this particular case.
To determine whether a patent claim is ineligible subject matter, the U.S. Supreme Court has established a two-step Alice/Mayo framework. In Step One, courts must determine whether the claims at issue are directed to a patent-ineligible concept such as an abstract idea. Alice, 573 U.S. at 208. In Step Two, if the claims are directed to an abstract idea, the courts must “consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Id. To transform an abstract idea into a patent-eligible application, the claims must do “more than simply stat[e] the abstract idea while adding the words ‘apply it.’” Id. at 221. At each step, the claims are considered as a whole. See id. at 218 n.3, 225.
a. Step One
With respect to claim 34, the Federal Circuit concluded, as the Board did, that the claim is directed to the abstract idea of selecting a fishing hook based on observed water conditions. Specifically, the Federal Circuit compared claim 34 with Elec. Power Grp., and reasoned that claim 34 requires nothing more than collecting information (water clarity and light transmittance) and analyzing that information (by applying the chart included in the claim), which collectively amount to the abstract idea of selecting a fishing hook based on the observed water conditions. See Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353–54 (Fed. Cir. 2016) (the Federal Circuit held in the computer context that “collecting information” and “analyzing” that information are within the realm of abstract ideas.).
The Federal Circuit disagreed with Mr. Rudy’s contention that claim 34’s preamble, “a method for fishing,” is a substantive claim limitation such that each claim requires actually attempting to catch a fish by placing the selected fishing hook in the water. The Federal Circuit reasoned that such an “additional limitation,” even if that were true, would not alter the conclusion because the character of claim 34 as a whole remains directed to an abstract idea.
The Federal Circuit also disagreed with Mr. Rudy’s contention that claim 34 is not directed to an abstract idea both because fishing “is a practical technological field . . . recognized by the PTO” and because he contends that observing light transmittance is unlikely to be performed mentally. Regarding the “practical technological field,” the Court reasoned that the undisputed fact that an applicant can obtain subject-matter eligible claims in the field of fishing is irrelevant to the fact that the claims currently before the Court are not eligible. Regarding the unlikeliness of the mental performance, the Court pointed our that the plain language of the claims encompasses such mental determination.
The Federal Circuit further rejected Mr. Rudy’s contention that, relying on the machine-or-transformation test, practicing claim 34 “acts upon or transforms fish” by transforming “freely swimming fish to hooked and landed fish” or by transforming a fishing hook “from one not having a target fish on it to one dressed with a fish when a successful strike ensues.” The Court declined to decide in this case whether the transformation from free fish to hooked fish is the type of transformation discussed in Bilski v. Kappos, 561 U.S. 593, 604 (2010) and its predecessor cases. Instead, the Court stated that claim 34 does not actually recite or require the purported transformation that Mr. Rudy relies upon because, as Mr. Rudy’s explained, “landing a fish is never a sure thing. Many an angler has gone fishing and returned empty handed.”
b. Step Two
In the Step Two Analysis, the Court concluded that claim 34 fails to recite an inventive concept at step two of the Alice/Mayo test, and is thus not patent eligible under 35 U.S.C. § 101 because the three elements of the claim (observing water clarity, measuring light transmittance, and selecting the color of the hook to be used), either individually or as an ordered combination, do not amount to “‘significantly more than a patent upon the ineligible concept itself.’” The argument in the Step Two Analysis appears somewhat cursory.
c. The Remaining Claims
The Federal Circuit concluded that claim 38, the only other independent claim on appeal, is not patent-eligible as well.
Claim 38 begins with a method that is substantively identical to claim 34, but includes a slightly different chart for selecting the fishing hook color, and further includes only one additional limitation, which recites: “wherein the fishing hook used is disintegrated from but is otherwise connectable to a fishing lure or other tackle and has a shaft portion, a bend portion connected to the shaft portion, and a barb or point at the terminus of the bend, and wherein the fishing hook used is made of a suitable material, which permits transmittance of light therethrough and is colored to colorless in nature.”
The Court stated that the slightly different substance of claim 38’s chart does not render it patent eligible because the substance of claim 34’s hook color chart was not the basis of the eligibility determination. The Court further stated that its step-one analysis of claim 34 is equally applicable to claim 38 because, as described above, this limitation does not change the fact that the character of the claim, as a whole, is directed to an abstract idea.
The Court also affirmed the Board’s conclusions that dependent claims 35, 37, and 40 are not patent eligible, as each recites the physical attributes of the connection between the fishing hook and the fishing lure in ways not meaningfully distinct from claim 38.
The Court further affirm the Board’s conclusions regarding claims 45–49, which differ from the previously discussed claims only in that they mandate a specific color of fishing hook, which neither changes the character of the claims as a whole, nor provides an inventive concept distinct from the abstract idea itself.
Takeaway
· The case demonstrates that courts still stick to the comparative approach in Alice step one, instead of defining or categorizing the “abstract idea.” This approach is notably in contrast with that of the Patent Office, which follows the Office Guidance, dividing Alice step one into two inquiries: (i) evaluate whether the claim recites a judicial exception; and (ii) evaluate whether the judicial exception is integrated into a practical application if the claim recites a judicial exception.
· To be on the safe side for the purpose of drafting a patent specification including claim(s), which is robust to an invalidity defense under 35 U.S.C. § 101, the Supreme Court’s law regarding patent eligibility, and the Federal Circuit’s interpretation and application thereof, not the Office Guidance, shall be relied on.
When there is competing evidence as to whether a prior art reference is a proper primary reference, an invalidity decision cannot be made as a matter of law at summary judgment
WHDA Blogging Team | April 29, 2020
Spigen Korea Co., Ltd. v. Ultraproof, Inc., et al.
April 17, 2020
Newman, Lourie, Reyna (Opinion by Reyna; Dissent by Lourie)
Summary
Spigen Korea Co., Ltd. (“Spigen”) sued Ultraproof, Inc. (“Ultraproof”) for infringement of its multiple patents directed to designs for cellular phone cases. The district court held that as a matter of law, Spigen’s design patents were obvious over prior art references, and granted Ultraproof’s motion for summary judgment of invalidity. However, based on the competing evidence presented by the parties, the United States Court of Appeals for the Federal Circuit (the “CAFC”) reversed and remanded, holding that a reasonable factfinder could conclude that a genuine dispute of material fact exists as to whether the primary reference was proper.
原告Spigen社は、自身の所有する複数の携帯電話ケースに関する意匠特許を被告Ultraproof社が侵害しているとして、提訴した。地裁は、原告の意匠特許は、先行技術文献により自明であるとして、裁判官は被告のサマリージャッジメントの申し立てを容認した。しかしながら、連邦控訴巡回裁判所（CAFC）は、双方の提示している証拠には「重要な事実についての真の争い（genuine dispute of material fact）」があるとして、地裁の判決を覆し、事件を差し戻した。
Details
Spigen is the owner of U.S. Design Patent Nos. D771,607 (“the ’607 patent”), D775,620 (“the ’620 patent”), and D776,648 (“the ’648 patent”) (collectively the “Spigen Design Patents”), each of which claims a cellular phone case. Figures 3-5 of the ’607 patent are as shown below:
The ’620 patent disclaims certain elements shown in the ’607 patent, and Figures 3-5 of the ’620 patent are shown below:
Finally, the ’648 patent disclaims most of the elements present in the ’620 patent and the ’607 patent, Figures 3-5 of which are shown below:
On February 13, 2017, Spigen sued Ultraproof for infringement of Spigen Design Patents in the United States District Court for the Central District of California. Ultraproof filed a motion for summary judgment of invalidity of Spigen Design Patents, arguing that the Spigen Design Patents were obvious as a matter of law in view of a primary reference, U.S. Design Patent No. D729,218 (“the ’218 patent”) and a secondary reference, U.S. Design Patent No. D772,209 (“the ’209 patent”). Spigen opposed the motion arguing that 1) the Spigen Design Patents were not rendered obvious by the primary and secondary reference as a matter of law; and 2) various underlying factual disputes precluded summary judgment. The district court held that as a matter of law, the Spigen Design Patents were obvious over the ’218 patent and the ’209 patent, and granted summary judgment of invalidity in favor of Ultraproof. Ultraproof then moved for attorneys’ fees, which the district court denied. Spigen appealed the district court’s obviousness determination, and Ultraproof cross-appealed the denial of attorneys’ fees.
On appeal, Spigen presented several arguments as to why the district court’s grant of summary judgment should be reversed. First, Spigen argued that there is a material factual dispute over whether the ’218 patent is a proper primary reference that precludes summary judgment. The CAFC agreed. The CAFC explained, citing Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1380-81 (Fed. Cir. 2009) (quoting Durling v. Spectrum Furniture Co., 101 F.3d 100, 103 (Fed. Cir. 1996)) that the ultimate inquiry for obviousness “is whether the claimed design would have been obvious to a designer of ordinary skill who designs articles of the type involved,” which is a question of law based on underlying factual findings. Whether a prior art design qualifies as a “primary reference” is an underlying factual issue. The CAFC went on to explain that a “primary reference” is a single reference that creates “basically the same” visual impression, and for a design to be “basically the same,” the designs at issue cannot have “substantial differences in the[ir] overall visual appearance[s].” Apple, Inc. v. Samsung Elecs. Co., 678 F.3d 1314, 1330 (Fed. Cir. 2012). A trial court must deny summary judgment if based on the evidence before the court, a reasonable jury could find in favor of the non-moving party. Here, the district court errored in finding that the ’218 patent was “basically the same” as the Spigen Design Patents despite there being “slight differences,” as a reasonable factfinder could find otherwise.
Spigen’s expert testified that the Spigen Design Patents and the ’218 patent are not “at all similar, let alone ‘basically the same.’” Spigen’s expert noted that the ’218 patent has the following features that are different from the Spigen Design Patents:
- unusually broad front and rear chamfers and side surfaces
- substantially wider surface
- lack of any outer shell-like feature or parting lines
- lack of an aperture on its rear side
- presence of small triangular elements illustrated on its chamfers
In contrast, Ultraproof argued that the ’218 patent was “basically the same” because of the presence of the following features:
- a generally rectangular appearance with rounded corners
- a prominent rear chamfer and front chamfer
- elongated buttons corresponding to the location of the buttons of the underlying phone
Ultraproof stated that the only differences were the “circular cutout in the upper third of the back surface and the horizontal parting lines on the back and side surfaces.”
Based on the competing evidence in the record, the CAFC found that a reasonable factfinder could conclude that the ’218 patent and the Spigen Design Patents are not basically the same. T
The CAFC determined that a genuine dispute of material fact exists as to whether the ’218 patent is a proper primary reference, and therefore, reversed the district court’s grant of summary judgment of invalidity and remanded the case for further proceedings.
Takeaway
When there is competing evidence in the record, the determination of whether a prior art reference creates “basically the same” visual impression, and therefore a proper primary reference, is a matter that cannot be decided at summary judgment.
A Patent Claim Is Not Indefinite If the Patent Informs the Relevant Skilled Artisan about the Invention’s Scope with Reasonable Certainty
Bo Xiao | April 23, 2020
NEVRO CORP. v. BOSTON SCIENTIFIC
April 9, 2020
Before MOORE, TARANTO, and CHEN, Circuit Judges. MOORE, Circuit Judge
中文标题
权利要求的不确定性判定
中文摘要
内夫罗公司（Nevro）起诉波士顿科学公司和波士顿科学神经调节公司（合称波士顿科学）侵犯了内夫罗公司的七项专利。 内夫罗公司对地方法院的专利无效判决提出上诉。根据专利说明书及其申请历史，联邦巡回法院认定“paresthesia-free,” “configured to,” “means for generating,” 和 “therapy signal” 等术语并未使内夫罗公司的权利要求产生不确定性，因此撤销专利无效判决并发回重审。
小结
- 仅因其为功能用语或仅通过专利权利的诠释不能将功能性语言判定为不确定。
- 功能性语言的确定性重要体现在专利说明书中需要有解释或支持功能术语的相关结构，特别是侧重方法的专利申请，如果这些申请中存在着系统或设备的权利要求， 而这些系统或设备权利要求由方法的权利要求转化而来，对系统或设备的必要描述是需要的。1
- 不确定性的判定标准存在于是否权利要求通过说明书和申请历史以合理的确定性向本领域技术人员告知了本发明的范围。
注1：许多专利申请通常使用诸如“模块”（module）和“单元”（unit）的术语，并将方法权利要求转换为系统或设备的权利要求。但是，在说明书中如果没有相关的结构说明，由于不确定性，通常这些权利要求会被拒绝。因此，专利说明书中有必要对“模块”或“单元”进行必要的描述，例如电子、通讯及软件类的专利申请，可添加一些与通用处理器，集成芯片或现场可编程门阵列有关的描述，以定义“模块”或“单元”并描述相关功能。
Summary
Nevro Corporation (Nevro) sued Boston Scientific Corporation and Boston Scientific Neuromodulation Corporation (collectively, Boston Scientific) for infringement of eighteen claims across seven patents. Nevro Corporation appealed the district court’s judgment of invalidity. The Federal Circuit found that the terms “paresthesia-free,” “configured to,” “means for generating,” and “therapy signal” are not rendering the asserted claims indefinite in view of the specifications and prosecution history, vacating and remanding the district court’s judgment of claim invalidity.
Background
Nevro owns seven patents having method and system claims directed to high-frequency spinal cord stimulation therapy for inhibiting an individual pain. Nevro sued Boston Scientific in the Northern District of California for patent infringement related to U.S. Patent Nos. 8,359,102; 8,712,533; 8,768,472; 8,792,988; 9,327,125; 9,333,357; and 9,480,842.
In a joint claim construction and summary judgment order, the district court held twelve claims invalid as indefinite. Though six asserted claims survived and were found definite, the district court granted Boston Scientific noninfringement. On appeal, the Federal Circuit concluded the district court erred in holding indefinite the claims reciting the terms “paresthesia-free,” “configured to,” and “means for generating.” The Federal Circuit also found the district court erred in its construction of the term “therapy signal,” though determined not indefinite by the district court. The Federal Circuit, therefore, vacated and remanded the district court’s judgment of invalidity of claims 7, 12, 35, 37 and 58 of the ’533 patent, claims 18, 34 and 55 of the ’125 patent, claims 5 and 34 of the ’357 patent and claims 1 and 22 of the ’842 patent.
Discussion
I. “paresthesia-free”
Several of Nevro’s asserted claims relate to methods and systems comprising a means for generating therapy signals that are “paresthesia-free.” Claim 18 of the ’125 patent and Claim 1 of the ’472 patent recite as follow:
18. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
means for generating a paresthesia-free therapy signal with a signal frequency in a range from 1.5 kHz to 100 kHz; and
means for delivering the therapy signal to the patient’s spinal cord at a vertebral level of from T9 to T12, wherein the means for delivering the therapy signal is at least partially implantable.
1. A method for alleviating patient pain or discomfort, without relying on paresthesia or tingling to mask the patient’s sensation of the pain, comprising:
implanting a percutaneous lead in the patient’s epidural space, wherein the percutaneous lead includes at least one electrode, and wherein implanting the percutaneous lead includes positioning the at least one electrode proximate to a target location in the patient’s spinal cord region and outside the sacral region;
implanting a signal generator in the patient; electrically coupling the percutaneous lead to the signal generator; and
programming the signal generator to generate and deliver an electrical therapy signal to the spinal cord region, via the at least one electrode, wherein at least a portion of the electrical therapy signal is at a frequency in a frequency range of from about 2,500 Hz to about 100,000 Hz.
The district court presented its findings based on extrinsic evidence that “[a]lthough the parameters that would result in a signal that does not create paresthesia may vary between patients, a skilled artisan would be able to quickly determine whether a signal creates paresthesia for any given patient.” While holding that the term “paresthesia-free” does not render the method claims indefinite, the district court held indefiniteness regarding the asserted system and device claims. The Federal Circuit disagreed the indefiniteness holdings because the test of indefiniteness should be simply based on whether a claim “inform[s] those skilled in the art about the scope of the invention with reasonable certainty.” The Federal Circuit states that the district court applied the wrong legal standard and the test for indefiniteness is not whether infringement of the claim must be determined on a case-by-case basis.
The Federal Circuit states that “paresthesia-free,” a functional term defined by what it does rather than what it is, does not inherently render it indefinite. Furthermore, the Federal Circuit instructs that
i. functional language can “promote[] definiteness because it helps bound the scope of the claims by specifying the operations that the [claimed invention] must undertake.” Cox Commc’ns, 838 F.3d at 1232.
ii. the ambiguity inherent in functional terms may be resolved where the patent “provides a general guideline and examples sufficient to enable a person of ordinary skill in the art to determine the scope of the claims.” Enzo Biochem. Inc. v. Applera Corp., 599 F.3d 1325, 1335 (Fed. Cir. 2010).
II. “configured to”
Nevro’s asserted claim 1 of the ’842 patent relates to a spinal cord modulation system, which recites:
1. A spinal cord modulation system comprising:
a signal generator configured to generate a therapy signal having a frequency of 10 kHz, an amplitude up to 6 mA, and pluses having a pulse width between 30 microseconds and 35 microseconds; and
an implantable signal delivery device electrically coupleable to the signal generator and configured to be implanted within a patient’s epidural space to deliver the therapy signal from the signal generator the patient’s spinal cord.
The district court held indefiniteness because it determined that “configured to” is susceptible to meaning one of two constructions: “(1) the signal generator, as a matter of hardware and firmware, has the capacity to generate the described electrical signals (either without further programing or after further programming by the clinical programming software); or (2) the signal generator has been programmed by the clinical programmer to generate the described electrical signals.”
The Federal Circuit pointed out that “the test [of indefiniteness] is not merely whether a claim is susceptible to differing interpretations” because “such a test would render nearly every claim term indefinite so long as a party could manufacture a plausible construction.” Further, the Federal Circuit states that the test for indefiniteness is whether the claims, viewed in light of the specification and prosecution history, “inform those skilled in the art about the scope of the invention with reasonable certainty.” Nautilus, 572 U.S. at 910. (emphasis added).
The specifications of the asserted patents and prosecution history, indeed, help Nevro win the argument on “configured” means. Nevro’s asserted patents not only recites that “the system is configured and programmed to,” but also Nevro agreed with the examiner that “configured” means “programmed” as opposed to “programmable.” The limitation specifies the interpretation of the term “configured” and leads to this favorable decision towards Nevro. The “programmed” and “programmable” may sound similar. However, “programmable” would be appliable to a general machine, since any general signal generator would have the capacity to generate the described signals. The term “programmed” sets out its specific settings of the signal generator and limits such broad interpretation.
III. “means for generating”
Several asserted claims of the ‘125 patent recite “means for generating,” in which claim 18 recites as follow:
18. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
means for generating a paresthesia-free therapy signal with a signal frequency in a range from 1.5 kHz to 100 kHz; and
means for delivering the therapy signal to the patient’s spinal cord at a vertebral level of from T9 to T12, wherein the means for delivering the therapy signal is at least partially implantable.
Nevro argued that the specification discloses a signal generator as the structure. The Federal Circuit agreed with Nevro and explained the difference comparing a general-purpose computer or processor. If the identified structure is a general-purpose computer or processor, it does require a specific algorithm. A signal or pulse generator is not considered as a general-purpose computer or processor, since it has the structure for the claimed “generating” function. Further, “the specification teaches how to configure the signal generators to generate and deliver the claimed signals using the recited parameters, clearly linking the structure to the recited function.” Hence, the Federal Circuit held that the district court erred in holding indefinite claims with the terms “means for generating.”
The terms such as “module” and “unit” are commonly used in many patent applications to convert method claims to system or device claims in electronic applications. However, without structural description in the specification, such claims are usually rejected due to indefiniteness. Hence, some may add some description related to general-purpose processors, integrated chips, or field-programmable gate arrays to define the “module” or “unit” and describe the functions.
IV. “therapy signal”
The Federal Circuit agreed that claims reciting a “therapy signal” are not indefinite, but held that the district court incorrectly construed the term. The Federal Circuit reiterated the context of the specification and prosecution history for understanding the words of a claim. It stated that “[t]he words of a claim are generally given their ordinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification and prosecution history.” Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).
Boston Scientific argued that the asserted claims reciting a “therapy signal” are indefinite because “two signals with the same set of characteristics (e.g., frequency, amplitude, and pulse width) may result in therapy in one patient and no therapy in another.” The Federal Circuit noted that “the fact that a signal does not provide pain relief in all circumstances does not render the claims indefinite.” Geneva, 349 F.3d at 1384.
Takeaway
- Functional language won’t be held indefinite simply for that reason or simply by interpreted in the claims.
- It is of importance to describe a related structure to support the functional terms in the specification, especially for applications having system or device claims converted from method claims.
- The test for indefiniteness is whether the claims, viewed in light of the specification and prosecution history, “inform those skilled in the art about the scope of the invention with reasonable certainty.” Nautilus, 572 U.S. at 910.
Tags: 35 U.S.C. § 112 > indefiniteness > Mean-Plus-Function > reasonable certainty
