BERYL A. HOWELL, District Judge.
Plaintiff SmartGene, Inc., a North Carolina corporation, brought this lawsuit against Defendant Advanced Biological Laboratories, SA, a company with its principal place of business in Luxembourg, seeking declaratory judgment as to the invalidity, unenforceability, and SmartGene's non-infringement of U.S. Patent No. 6,081,786 (the "786 patent") and U.S. Patent No. 6,188,988 B1 (the "988 patent") (collectively, the "patents-in-dispute"). After prolonged litigation, including a stay of proceedings of two and a half years, SmartGene filed a Motion for Partial Summary Judgment, contending that the "patents-in-dispute" are facially invalid under 35 U.S.C. § 101 of the Patent Act because the subject matter is ineligible for patent protection.
The patents at stake in this dispute are Patent Nos. 6,081,786 (the "786 patent") and 6,188,988 B1 (the "988 patent"), of which the defendants are the undisputed owners. Compl. ¶¶ 7-8.
Both patents are entitled "Systems, Methods and Computer Program Products for Guiding the Selection of Therapeutic Treatment Regimens," and relate "to a system, method, and computer program for guiding the selection of therapeutic treatment regimens for complex disorders ... by ranking available treatment regimens and providing advisory information." Defs.' Mem. in Opp. to Mot. for Partial Summ. J. ("Defs.' Mem."), ECF No. 50, at 1-2. Both patents-in-dispute are based on the same patent specifications and disclosures, and relate to methods (i.e., process) and systems for an interactive, computerized program for guiding the selection of therapeutic treatment regimens for a patient based on input provided by a physician. See Pl.'s Mem. in Support of Mot. for Partial Summ. J. ("Pl.'s Mem."), ECF No. 47, at 3; Defs.' Mem. at 1-2. The defendants sum up their invention as follows: "Element (a) specifies that the physician provide patient information to the computing device which includes prior therapeutic treatment regimen information. This information is then processed against a first knowledge base that contains different treatment regimens and a second knowledge base of expert rules. The computing device then generates available treatments along with advisory information for those treatments. By providing the patient information to the system and allowing interaction with the physician, the Patents describe how therapeutic treatment regimens can be listed with corresponding advisory information." Defs.' Mem. at 11.
The Court's analysis focuses on the patentability of Claim 1 of the '786 patent. The language for Claim 1 in both the '786 and '988 patent is nearly identical. SmartGene asserts that the differences between Claim 1 in the '786 patent and '988 patent are insignificant, and that these first claims are representative of all of the claims of the patents-in-dispute. Pl.'s Mem. at 8 n. 3. The defendants failed to
'786 patent, Col. 17-18, ECF No. 4-1.
The litigation between these parties originated in September 2007, when ABL SA filed a lawsuit in the United States District Court for the Eastern District of Texas, Marshall Division, against SmartGene, alleging that SmartGene "manufactures, uses and sells products that infringe the '786 and '988 Patents." Compl. ¶ 9. ABL SA alleged specifically that "Smartgene's IDNS™ HIV program incorporates at least one technology which infringes at least claim 1 of each [of] the '786 and '988 Patents." Id. The district court in Texas dismissed the case on April 10, 2008 for lack of personal jurisdiction. Id. at 10.
SmartGene commenced this action in the District Court for the District of Columbia against ABL SA on April 11, 2008, seeking declaratory judgment of non-infringement, patent invalidity, and patent unenforceability under the Patent Act, 35 U.S.C. § 1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201-2202.
ABL SA filed its Answer and Counterclaims on October 6, 2008, alleging that SmartGene's products "[incorporate] at least one technology which infringes at least claim 1 of each of the '786 and the '988 patents." Answer, ECF No. 12, at ¶ 42.
On February 3, 2009, SmartGene's unopposed motion to stay this proceeding, see ECF No. 18, was granted due to concurrent patent validity reexaminations brought before the PTO. See Order, ECF No. 19. Cumulatively, the defendants advise that the PTO held six reexaminations — three for each of the patents-in-dispute — with two reexaminations combined for each patent. Tr. 45:11-13. None of the reexamination proceedings, however, addressed the subject matter eligibility question under 35 U.S.C. § 101. Tr. 45:16. The PTO completed its reexamination proceedings and issued a final non-appealable denial of further review proceedings on June 14, 2011. Joint Motion to Lift Stay, ECF. No. 32, at 1. The PTO concluded that all of the claims of both patents-in-dispute were patentable over the prior art presented during the reexamination. Id.
On September 7, 2011, the parties filed a joint motion to lift the stay and submitted a proposed scheduling order. Id. This case was then reassigned to the undersigned Judge on September 15, 2011.
This Court lifted the stay on October 21, 2011, and subsequently entered a scheduling order to govern the proceedings in this matter. See Minute Order (Oct. 21, 2011); Scheduling Order, ECF No. 39. SmartGene filed the instant Motion for Partial Summary Judgment on December 12, 2011, alleging that the '786 patent and the '988 patent constituted ineligible patent subject matter under 35 U.S.C. § 101 and pursuant to Bilski v. Kappos, ___ U.S. ___, 130 S.Ct. 3218, 177 L.Ed.2d 792 (2010). See ECF No. 47. Both parties agree that the resolution of this motion does not depend on the disposition of any facts. Pl.'s Mem. at 2; Tr. 28:10-15.
Pursuant to Rule 56 of the Federal Rules of Civil Procedure, summary judgment shall be granted "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." FED. R. CIV. P. 56(a); Anderson v. Liberty Lobby, 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); Estate of Parsons v. Palestinian Authority, 651 F.3d 118, 123 (D.C.Cir.2011); Tao v. Freeh, 27 F.3d 635, 638 (D.C.Cir.1994). Summary judgment is properly granted against a party who, "after adequate time for discovery and upon motion, ... fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). The burden is on the moving party to demonstrate that there is an "absence of a genuine issue of material fact" in dispute. Celotex Corp., 477 U.S. at 323, 106 S.Ct. 2548.
In ruling on a motion for summary judgment, the court must draw all justifiable inferences in favor of the nonmoving party, and shall accept the nonmoving party's evidence as true. Anderson, 477 U.S. at 255, 106 S.Ct. 2505; Estate of Parsons, 651 F.3d at 123; Tao, 27 F.3d at 638. The court is only required to consider the materials explicitly cited by the parties, but may on its own accord consider "other materials in the record." FED. R. CIV. P. 56(C)(3). For a factual dispute to be "genuine," Estate of Parsons, 651 F.3d at 123, the nonmoving party must establish more than "[t]he mere existence of a scintilla of evidence" in support of its position, Anderson, 477 U.S. at 252, 106 S.Ct. 2505, and cannot simply rely on allegations or conclusory statements. Greene v. Dalton, 164 F.3d 671, 675 (D.C.Cir.1999). Rather, the nonmoving party must present specific facts that would enable a reasonable jury to find in its favor. Id. If the evidence "is merely colorable, ... or is not significantly probative, ... summary judgment may be granted." Anderson, 477 U.S. at 249-50, 106 S.Ct. 2505 (citations omitted).
SmartGene's Motion for Partial Summary Judgment challenges the subject matter eligibility of the patents-in-dispute under 35 U.S.C. § 101. See Pl.'s Mot. for Part. Summ. J. ("Pl.'s Mot."), ECF No. 47. Congress has defined which inventions are patentable in Section 101 of the Patent Act, which states in its entirety:
35 U.S.C. § 101.
The Patent Act defines the term "process" as "process, art or method, and includes a new use of a known process,
The Supreme Court has further elaborated on what constitutes a patentable process claim, noting that
Diamond v. Diehr, 450 U.S. 175, 182-83, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981) (quoting Cochrane v. Deener, 94 U.S. 780, 787-88, 24 L.Ed. 139 (1877)).
While the Patent Act covers a broad range of subject matter, there are three important subject matter exceptions from patentability: "laws of nature, physical phenomena, and abstract ideas." Bilski v. Kappos, ___ U.S. ___, 130 S.Ct. 3218, 3225, 177 L.Ed.2d 792 (2010) ("Bilski II") (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980)); Gottschalk v. Benson, 409 U.S. 63, 67, 93 S.Ct. 253, 34 L.Ed.2d 273 (1972). The Supreme Court has found that these categories of exceptions "are not patentable, as they are the basic tools of scientific and technological work." Benson, 409 U.S. at 67, 93 S.Ct. 253. "Thus, the Court has written that a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc
Patents issued by the PTO, and their underlying claims, are presumed valid. See 35 U.S.C. § 282. "[T]his presumption can only be overcome by clear and convincing evidence to the contrary." Unique Indus. v. 965207 Alta. Ltd., 843 F.Supp.2d 86, 88-89, No. 08-1095, 2012 WL 506869, at *1, 2012 U.S. Dist. LEXIS 19621, at *2 (D.D.C. Feb. 16, 2012); Eli Lilly & Co. v. Barr Labs., 251 F.3d 955, 962 (Fed.Cir. 2001); Apple Computer v. Articulate Sys., 234 F.3d 14, 20 (Fed.Cir.2000).
The determination of whether a claimed invention is invalid for lack of subject matter patentability under 35 U.S.C. § 101 is a "threshold inquiry" and a matter of law. See In re Bilski, 545 F.3d 943, 950-51 (Fed.Cir.2008) ("Bilski I"). "[A]ny claim of an application failing the requirements of § 101 must be rejected even if it meets all of the other legal
The fact that the PTO conducted reexaminations of the patents-in-dispute does not trigger higher deference on the issue of subject matter patentability because the PTO cannot review subject matter eligibility during a reexamination proceeding. 37 C.F.R. § 1.552. This lawsuit, therefore, is not dealing with matters previously covered during the reexamination proceedings. Id. Titled "Scope of reexamination in ex parte reexamination proceedings," § 1.552 states, in relevant part, that upon ex parte reexamination, the PTO may only examine the contested patent "on the basis of patents or printed publications and, with respect to subject matter added or deleted in the reexamination proceeding, on the basis of the requirements of 35 U.S.C. § 112." It further states that "[i]ssues other than those indicated ... will not be resolved in a reexamination proceeding. If such issues are raised by the patent owner or third party requester during a reexamination proceeding, the existence of such issues will be noted by the examiner in the next Office action, in which case the patent owner may consider the advisability of filing a reissue application to have such issues considered and resolved." 37 C.F.R. § 1.552. "Thus, other challenges to the patentability of original claims — such as qualification as patentable subject matter under § 101 or satisfaction of the written description and enablement requirements of § 112 — may not be raised in reexamination proceedings." In re NTP, 654 F.3d 1268, 1275-76 (Fed.Cir. 2011); see also 35 U.S.C. § 302 (reexaminations may be conducted on "the basis of any prior art"). Since this issue cannot be raised in a reexamination proceeding, no additional deference is accorded to the PTO as to subject matter patentability.
In its Motion for Partial Summary Judgment, SmartGene contends that the patents-in-dispute constitute ineligible patent subject matter because they are (1) "directed to abstract ideas and mental processes," and because (2) the patents-in-dispute fail the "machine or transformation" ("MOT") test articulated in Bilski, and are thus invalid. Pl.'s Mem. at 1. In support of this contention, SmartGene asserts that the patents-in-dispute are "directed to nothing more than a mental process in which a person, e.g., a physician, engages when determining a treatment for a patient suffering from a disease or a medical condition." Pl.'s Mem. at 6.
The defendants respond that (1) the claims at issue are not directed to an abstract
Guided by Supreme Court and Federal Circuit precedent in this area, the Court proceeds with its analysis by (A) examining 35 U.S.C. § 101 as a "threshold" inquiry into patent validity; (B) reviewing Supreme Court caselaw "guideposts" on the subject of patent subject matter eligibility; and then examining whether the patents-in-dispute (C) satisfy the MOT test, and (D) constitute eligible subject matter irrespective of the MOT test. Finally, although the Court does not formally construct the claims on which there is disagreement between the parties, the Court (E) examines the claim construction proposals to inform its section 101 analysis. The Court concludes that the relevant precedent and tests demonstrate that the patents-in-dispute constitute ineligible subject matter and are thus invalid.
As the Supreme Court noted in Bilski v. Kappos, the 35 U.S.C. § 101 inquiry is a "threshold test." Bilski II, ___ U.S. ___, 130 S.Ct. 3218, 3225, 177 L.Ed.2d 792 (2010). "It is well-established that [t]he first door which must be opened on the difficult path to patentability is § 101." CLS Bank Int'l. v. Alice Corp. Pty. Ltd., 768 F.Supp.2d 221, 233 (D.D.C.2011) (citation and quotation marks omitted). A recent Federal Circuit decision, however, cast doubt on this approach, sharply questioning the wisdom of utilizing the § 101 subject matter inquiry as a threshold question. See MySpace, Inc. v. GraphOn Corp., 672 F.3d 1250 (Fed.Cir.2012). In a majority decision, the Federal Circuit cautioned that lower courts should avoid the "swamp of verbiage that is § 101 by exercising their inherent power to control the processes of litigation, ... and insist that litigants initially address patent invalidity issues in terms of the conditions of patentability defenses as the statute provides, specifically §§ 102, 103, and 112." Id. at 1260 (internal citation omitted). The decision asserts that this approach would alleviate the necessity of entering "the murky morass that is § 101 jurisprudence." Id.; see also Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1073-75 (Fed.Cir.2011) (urging judicial restraint in the face of a plethora of section 101 litigation).
Following the Motions Hearing in this case, however, the Supreme Court, in Mayo Collaborative Servs. v. Prometheus Labs., ___ U.S. ___, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012), clarified that a 35 U.S.C. § 101 subject matter patentability inquiry is the threshold analysis for determining patent validity. The Supreme Court explicitly rejected that the "screening
The Supreme Court has highlighted a trilogy of its decisions — namely Gottschalk v. Benson, Parker v. Flook, and Diamond v. Diehr — as useful "guideposts" when considering exceptions to patent subject matter eligibility under 35 U.S.C. § 101. Bilski II, 130 S.Ct. at 3231. The Court notes that "[i]n searching for a limiting principle, [the Supreme Court's] precedents on the unpatentability of abstract ideas provide useful tools." Id. at 3229. The most recent Supreme Court decision on this topic, Prometheus, reaffirms the importance of these tools, focusing its section 101 analysis, inter alia, on this trilogy of cases as well as Bilski II. See Prometheus, 132 S.Ct. at 1298-1301. This Court follows suit. The Court reviews these guideposts below, and finds that, under this instructive precedent, the patents-in-dispute are not patent-eligible processes.
The Supreme Court's decision in Benson is the first of these patent subject matter eligibility cases. Gottschalk v. Benson, 409 U.S. 63, 93 S.Ct. 253, 34 L.Ed.2d 273 (1972). There, the Supreme Court held that "a method for converting binary-coded decimal (BCD) numerals into pure binary numerals" that was "not limited to any particular art or technology, to any particular apparatus or machinery, or to any particular end use" was not a process covered by the Patent Act. Id. at 64, 71-73, 93 S.Ct. 253. The claimed method sought patent protection over an "algorithm" that represented "a generalized formulation for programs to solve mathematical problems of converting one form of numerical representation to another." Id. at 65, 93 S.Ct. 253. The Supreme Court observed that "[t]he mathematical formula involved here has no substantial practical application except in connection with a digital computer, which means that if the judgment below is affirmed, the patent would wholly preempt the mathematical formula and in practical effect would be a patent on the algorithm itself." Id. at 71-72, 93 S.Ct. 253. The Court expressed concern that "the `process' claim is so abstract and sweeping as to cover both known and unknown uses," which could "vary from the operation of a train to verification of drivers' licenses to researching the law books
"In Flook, the Court considered the next logical step after Benson." Bilski II, 130 S.Ct. at 3230. There, the patent-holder asserted patent rights protection over a "method for updating alarm limits," which indicated the point at which the catalytic conversion conditions in the petrochemical and oil-refining industries can produce inefficiencies or danger. Parker v. Flook, 437 U.S. 584, 585, 98 S.Ct. 2522, 57 L.Ed.2d 451. As the Court noted, "[t]he only novel feature of the method is a mathematical formula." Id. "In [Benson], we held that the discovery of a novel and useful mathematical formula may not be patented. The question in this case is whether the identification of a limited category of useful, though conventional, post-solution applications of such a formula makes respondent's method eligible for patent protection." Id. The Court found that the "only difference between the conventional methods of changing alarm limits and that described in respondent's application rests in the second step — the mathematical algorithm or formula" and that "a claim for an improved method of calculation, even when tied to a specific end use, is unpatentable subject matter under § 101." Id. at 595 & n. 18, 98 S.Ct. 2522.
Moreover, the Court found that incorporation of "post-solution" activity did not render the formula patentable, because a "competent draftsman could attach some form of post-solution activity to almost any mathematical formula." Id. at 590, 98 S.Ct. 2522. The Court rejected the idea that post-solution activity, "no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process," finding that would "[exalt] form over substance." Id. The Pythagorean theorem, for example, would not have been patentable even if a final step had been added "indicating that the formula, when solved, could be usefully applied to existing surveying techniques." Id. The patent thus constituted ineligible subject matter because the claim sought patent protection over an improved method for computing alarm limits, which were otherwise computable by hand. Id. As the Court explained in Diehr and Bilski II, "Flook stands for the proposition that the prohibition against patenting abstract ideas `cannot be circumvented by attempting to limit the use of the formula to a particular technological environment' or adding `insignificant postsolution activity.'" Bilski II, 130 S.Ct. at 3230 (quoting Diehr, 450 U.S. at 191-92, 101 S.Ct. 1048).
In Diehr, the Supreme Court "established a limitation on the principles articulated in Benson and Flook." Bilski II, 130 S.Ct. at 3230. The Court upheld as patentable subject matter a process for molding, or "curing," raw synthetic rubber into a product that would retain its shape. This process involved using the well-known components of time, temperature and a mathematical formula, but combined them with a previously uncontrollable variable (i.e., the temperature inside of a rubber press) and use of a programmed computer. Diamond v. Diehr, 450 U.S. 175, 187, 101 S.Ct. 1048,
Unlike in Benson, where the "sole practical application of the algorithm was in connection with the programming of a general purpose digital computer," Diehr, 450 U.S. at 185-86, 101 S.Ct. 1048, the claimed invention in Diehr used a mathematical equation tied to "all of the other steps in their claimed process," which itself was limited to curing synthetic matter. Id. at 187, 101 S.Ct. 1048. The Supreme Court acknowledged that although, "[o]bviously, one does not need a `computer' to cure natural or synthetic rubber," when the computer significantly reduces the probability of damaging the rubber, the process is not rendered unpatentable solely because of the use of a mathematical formula or computer. Id.
The Supreme Court articulated the following guidance: "A mathematical formula as such is not accorded the protection of our patent laws [citing Benson], and this principle cannot be circumvented by attempting to limit the use of the formula to a particular technological environment [citing Parker]. Similarly, insignificant post-solution activity will not transform an unpatentable principle into a patentable process. Ibid." Diehr, 450 U.S. at 191-92, 101 S.Ct. 1048. The Court went on to say, however, that, "when a claim containing a mathematical formula implements or applies that formula in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect (e.g., transforming or reducing an article to a different state or thing), then the claim satisfies the requirements of § 101." Id. at 192, 101 S.Ct. 1048.
In Bilski II, the Supreme Court held that the trilogy of cases discussed above — Benson, Flook, and Diehr — made "clear that petitioner's application [for a business method for hedging risk in the energy commodities market] is not a patentable process." 130 S.Ct. at 3231 (quotation marks omitted). The Court stated that the patent application sought protection over a "fundamental economic practice long prevalent in our system of commerce and taught in any introductory finance class." Id. at 3231 (citation omitted). The Court found that "[t]he concept of hedging, described in claim 1 and reduced to a mathematical formula in claim 4, is an unpatentable abstract idea, just like the algorithms at issue in Benson and Flook. Allowing petitioners to patent risk hedging would preempt use of this approach in all fields, and would effectively grant a monopoly over an abstract idea." Id. The Court drew this conclusion "narrowly on the basis of this Court's decisions in Benson, Flook, and Diehr, which show that petitioners' claims are not patentable processes because they are attempts to patent abstract ideas." Id. at 3229-30.
The most recent guidance from the Supreme Court on section 101 analysis concerns patent claims covering a process aimed to aid doctors administering thiopurine
Specifically, the Prometheus Court distilled the guideposts from its earlier section 101 cases into the following "warnings." The Supreme Court warned "against interpreting patent statutes in ways that make patent eligibility `depend simply on the draftsman's art' without reference to the `principles underlying the prohibition against patents for [natural laws],'" id. (quoting Flook, 437 U.S. at 593, 98 S.Ct. 2522), and warned against "upholding patents that claim processes that too broadly preempt the use of a natural law." Id. (citing O'Reilly v. Morse, 56 U.S. 62, 112-120, 15 How. 62, 14 L.Ed. 601). A "process that focuses upon the use of a natural law" must "contain other elements or a combination of elements, sometimes referred to as an `inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself." Id. (quoting Flook, 437 U.S. at 594, 98 S.Ct. 2522). The Court found that the patent at issue failed this test, explaining that "the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field." Id. The Court further observed that "upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries," and thereby allowing monopolies of unforeseeable scope. Id.
This Court finds that, as in Benson, Flook, Bilski II, and Prometheus, the "patent application here can be rejected under [the Supreme Court's] precedents..." Bilski II, 130 S.Ct. at 3231. Mental processes and abstract intellectual concepts are simply not patentable for the sound reason that "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Prometheus, 132 S.Ct. at 1293. The patents-in-dispute do no more than describe just such an abstract mental process engaged in routinely, either entirely within a physician's mind, or potentially aided by other resources in the treatment of patients.
Specifically, the claim here, like the claim in Prometheus, "presents a case for patentability that is weaker than the (patent-eligible) claim in Diehr and no stronger than the (unpatentable) claim in Flook." Id. at 1299. In Diehr, as noted, the parties sought patent protection over the use of a mathematical equation "in conjunction with all of the other steps in their claimed process. These include[d] installing rubber in a press, closing the mold, constantly determining the temperature of the mold, constantly recalculating the appropriate cure time through the use of the formula and a digital computer, and automatically opening the press at the proper time." Diehr, 450 U.S. at 187, 101 S.Ct. 1048. The Court found that the invention was patentable under section 101 because it was not "an attempt to patent a mathematical formula, but rather [was] an industrial
The claims at issue here are also analogous to the claim in In re Meyer, 688 F.2d 789 (C.C.P.A.1982), a case before the United States Court of Customs and Patent Appeals. There, the patent applicant sought patent protection over a process for gathering neurological testing data, imputing it into a computer, and using a formula to infer whether certain neurological elements are functioning. In re Meyer, 688 F.2d at 793. The United States Court of Customs and Patent Appeals rejected the patent owner's assertion that the invention was "concerned with replacing, in part, the thinking processes of a neurologist with a computer," and instead concluded that, "the process recited is an attempt to patent a mathematical algorithm rather than a process for producing a product as in [Diehr]." Id. at 794. Here, the defendants have stated that "the purpose of [their] invention was to provide the practitioner with help, to give the practitioner more than he could have just in his mind." See Tr. 35:16-18. This Court rejects this argument where the patents-in-dispute are even more abstract than in Meyer, which at least involved a mathematical algorithm.
Before proceeding to the machine-or-transformation test that the Supreme Court has highlighted as an "important tool" in section 101 analysis, the Court first examines the '786 patent step-by-step in the context of the Court's precedent, as the Court did in Prometheus. Set against this binding precedent, the Court concludes that nothing in Claim 1 of the '786 patent transforms the everyday abstract ideas on which it is based into patentable processes.
"[W]hen a court examines whether a claim is directed to an abstract idea, the court must view each claim as a whole." CLS Bank Int'l v. Alice Corp. Pty. Ltd., 768 F.Supp.2d 221, 232 (D.D.C.2011). The Court views Claim 1 as a whole but still finds it useful to examine the claim in steps for the purposes of its analysis of the claim as a whole. The first step of Claim 1 of the '786 patent describes "[a] method for guiding the selection of a therapeutic treatment regimen for a patient with a known disease or medical condition, said method comprising." As SmartGene highlights, the language of the claim is directed to "nothing more than a mental process..." Pl.'s Mem. at 6. In fact, this process is one that is performed in doctors' offices everyday. A doctor speaks with a patient, who describes his or her ailments. The
The second step of Claim 1 of the '786 patent addresses "(a) providing patient information to a computing device comprising [three knowledge databases]." The Court sees nothing in this step that is any different than the process a doctor goes through in real time when a doctor evaluates a patient by taking a medical history and obtaining information pertinent to the patient's condition and documenting the same in a medical chart. Similarly, the patents' reference to three databases also mimics the evaluative process involved in the treatment of patients. Specifically, after collecting patient information, a doctor would consider "therapeutic treatment regimens for said disease or medical condition" (as in the first knowledge base), consult "expert rules for evaluating and selecting a therapeutic treatment regimen for said disease or medical condition" (as in the second knowledge base), and review "advisory information useful for the treatment of a patient with different constituents of said different therapeutic treatment regimens" (as in the third database). The claim itself does not add anything to the process that doctors regularly engage in mentally when evaluating and treating patients.
The next step of Claim 1 of the '786 patent is "(b) generating in said computing device a ranked listing of available therapeutic treatment regimens for said patient." The Court views this step as describing what goes on in the mind of a doctor in evaluating and ranking possible treatment options for a patient based upon the benefits and counter-indicators of each option.
The final step of Claim 1 of the '786 patent is "(c) generating in said computing device advisory information for one or more therapeutic treatment regimens in said ranked listing based on said patient information and said expert rules." The Court understands this step as corresponding to a doctor generating a treatment plan for a patient.
In essence, these four steps describe abstract ideas that are commonly performed by medical professionals in evaluating, considering and constructing treatment options for a patient presenting a specific medical condition. As with the claim examined in Prometheus, these "steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons [this Court believes] that the steps are not sufficient to transform unpatentable [abstract ideas] into patentable applications...." Prometheus, 132 S.Ct. at 1298. In short, the claims track the abstract mental processes of a doctor treating a patient. Accordingly, analyzing Claim 1 of the '786 patent under the Supreme Court's precedent, this Court finds that the claims of the patents-in-dispute are abstract ideas and unpatentable.
The Court also finds that the patents-in-dispute are invalid under the "machine-or-transformation" or "MOT" test
In Bilski II, the Supreme Court notably rejected the Federal Circuit's decision that the "machine or transformation" test was the "sole test for governing § 101 analysis." 130 S.Ct. at 3227. The Court found that while "[i]t is true that patents for inventions that did not satisfy the machine-or-transformation test were rarely granted in earlier eras ... times change." Id. The Court reflected generally that "[w]ith ever more people trying to innovate and thus seeking patent protections for their inventions, the patent law faces a great challenge in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles." Id. at 3228. The Court, however, did not foreclose the use of the machine-or-transformation test. Id. at 3227. Indeed, while the Supreme Court emphasized that the MOT test is "not the sole test for deciding whether an invention is a patent-eligible `process,'" the Court noted that the Supreme Court's "precedents establish that the [MOT] test is a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101." Id. Most recently, in Prometheus, the Supreme Court rejected not the MOT test but the Federal Circuit's application of that test. There, the Federal Circuit concluded that the transformation prong of the MOT test was satisfied because the claimed process involved "transforming the human body by administering a thiopurine drug and transforming the blood by analyzing it to determine the metabolite levels." Prometheus, 132 S.Ct. at 1302. The Court described as "irrelevant" the transformation on which the Federal Circuit upheld the patent at issue since no part of the so-called "transformation" required the claimed process. Id. Accordingly, this Court employs the MOT test as a useful investigative tool.
Under the MOT test, a process claim is patentable if "(1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." Bilski I, 545 F.3d at 954; see also Flook, 437 U.S. at 589 n. 9, 98 S.Ct. 2522 ("An argument can be made [that the Supreme Court] has only recognized a process as within the statutory definition when it either was tied to a particular apparatus or operated to change materials to a different state or thing.") (internal quotation marks and citations omitted). The "use of a specific machine or transformation of an article must impose meaningful limits on the claim's scope to impart patent-eligibility" and, furthermore, "the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity." CLS Bank Int'l, 768 F.Supp.2d at 234 (citations and quotation marks omitted). SmartGene claims that the patents-in-dispute "[a]ll fail" the MOT
To satisfy this prong, a claimed process must be "tied to a particular machine or apparatus." Bilski I, 545 F.3d at 954. SmartGene argues that "[t]he claims of the patents-in-suit are essentially methods for providing and generating information, and do not identify a particular machine for performing the recited claim steps. While the claims reference a `computing device,' this generic token reference does not identify any particular machine or provide any indication of what particular type of machine is to be used ..." Pl.'s Mem. at 12. The defendants argue in response that the claims meet the machine prong of the MOT test "because the claims are tied to a particular machine that has [three databases]" and "[i]t can hardly be argued that the computing device is incidental to the invention, rather the computing device allows the invention to pull information from three databases." Defs.' Mem. at 12-13. The Court finds that the patents-in-dispute do not satisfy the machine prong for two reasons.
First, the claims of the patents-in-dispute do not refer to any "particular" machine. While the claims reference a "computing device," these references are insufficient to satisfy the machine test. The defendants argue that "the figures and specification specify how the computer is to be specially programmed to implement the method covered by the Asserted Claims," but the Court is not persuaded. Defs.' Mem. at 13.
To the extent that the claims reference a machine at all, they reference a "general purpose computer," which does not satisfy the machine prong. See, e.g., CLS Bank Int'l., 768 F.Supp.2d at 237 ("With evolving guidance on this issue, district courts have determined that a method claim that is directed to a general purpose computer is not tied to a particular machine under the MOT test.") (citations omitted); Graff/ Ross Holdings LLP v. Fed. Home Loan Mortg. Corp., No. 07-796, 2010 WL 6274263, at *6, 2010 U.S. Dist. LEXIS 141399, at *20 (D.D.C.2010) (finding that a "computer processor" referenced in method claim is not a "particular machine" under the MOT test); Accenture Global Services, GmbH v. Guidewire Software, Inc., 691 F.Supp.2d 577, 597 (D.Del.2010) ("data processing system", "claim folder", "display device", and "screen" referenced in claim did not constitute a "particular machine" for the purposes of the MOT test); see also ECF No. 55, Ex. A, July 8, 2009 Office Action for Patent Application No. 10/857, 105 ("105 Application") (application where the PTO found that the term "computing device" did not refer to a particular machine and rejected claims on that basis).
The defendants argue that the Court should look to VS Techs., LLC v. Twitter, Inc., No. 2:11-cv-43, 2011 WL 4744911, 2011 U.S. Dist. LEXIS 114998 (E.D.Va. Oct. 4, 2011), as "[a] good example of the proper application of the machine prong..." Defs.' Mem. at 12. There, the court found that a claim satisfied the machine prong because "the patent constitutes a practical application of an idea." VS Techs., LLC, 2011 WL 4744911, at *4, 2011 U.S. Dist. LEXIS 114998, at *14-15. The Court finds, to the contrary, that the caselaw is clear that allowing a process to become patentable simply because it is computer aided and constitutes a practical application would render the subject-matter eligibility criteria contained in section 101 meaningless. See Dealertrack, Inc. v. Huber, 674 F.3d at 1332-33 (concluding that claims drawn to a "computer-aided" method of processing information through a clearinghouse were ineligible abstract ideas under section 101); CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1375 (Fed.Cir.2011) (emphasizing "that the basic character of a process claim drawn to an abstract idea is not changed by claiming only its performance by computers, or by claiming the process embodied in program instructions on a computer readable medium").
Defs. Cl. Constr. Br. at 6 (quoting, inter alia, '786 patent, Col. 8, lines 25-37). The Court finds that general references to other patents as "examples" of components of a structure without any detail as to implementation or combination is simply insufficient to identify a structure in the claims. This is fatal for the defendants' claims. Accordingly, the Court finds that nothing in the defendants' proposed claim construction helps them satisfy the "machine" prong of the MOT test.
Second, the computing device referenced in the claims is incidental to the claimed invention and is not used for more than "insignificant postsolution activity," and thus does not satisfy the machine prong. Diehr, 450 U.S. at 191, 101 S.Ct. 1048. As in Flook, the computing device is merely a means of improving an existing process, which does not make the claims of the patents-in-dispute patentable. Flook, 437 U.S. at 595 n. 18, 98 S.Ct. 2522. Indeed, when a computer is functioning simply to speed up a process, this does not make the process patentable. CLS Bank Int'l, 768 F.Supp.2d at 238-39 ("In order for the addition of a machine to impose a meaningful limit on the scope of a claim, it must play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly"); see also CyberSource, 654 F.3d at 1375-76 (case would be different if "as a practical matter, the use of a computer [was] required"). In the patents-in-dispute, the computing device referenced in the claims appears to be doing nothing more than speeding up the research and mental processes that a doctor normally goes through when evaluating the best treatment options or regimen for a given patient. Thus, Claim 1 of the '786 patent does not satisfy the machine prong of the MOT test.
To satisfy the "transformation" prong of the MOT test, a claimed process must "[transform] a particular article into
The Supreme Court and Federal Circuit have offered some guidance in deciphering whether a process satisfies the transformation prong. First, the "transformation must be central to the purpose of the claimed process" see Bilski I, 545 F.3d at 962, and the "mere manipulation or reorganization of data ... does not satisfy the transformation prong." CyberSource, 654 F.3d at 1375. Second, "[p]urported transformations or manipulations simply of public or private legal obligations or relationships, business risks, or other such abstractions cannot meet the test because they are not physical objects or substances, and they are not representative of physical objects or substances." Bilski I, 545 F.3d at 963. Finally, as noted, the Supreme Court in Prometheus recently rejected the Federal Circuit's application of "transformation," where the Federal Circuit concluded that claimed processes were patent eligible where they involved "transforming the human body." Prometheus, 132 S.Ct. at 1302-1303. The Supreme Court in Prometheus, however, did not retreat from a transformation analysis as part of a subject matter patentability test under section 101.
The Federal Circuit's guidance in CyberSource is particularly instructive. In CyberSource, the Federal Circuit held that a method for detecting credit card fraud in internet commerce constituted ineligible patent subject matter. Id. There, the parties sought patent protection over a process that compares databases comprised of credit card transaction history information to determine whether current purchases are indicative of credit card users' purchasing habits. 654 F.3d at 1367. The Federal Circuit concluded that such an invention does not constitute patent eligible subject matter because it "can be performed by human thought alone ..." Id. at 1373. The Federal Circuit also explicitly stated that the mere use of the internet does not create patentable subject matter, because the internet is utilized as a "source of data," and "mere [data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory." Id. at 1370 (quoting In re Grams, 888 F.2d 835, 840 (Fed.Cir.1989)). The Federal Circuit found that the patents-in-dispute did not satisfy the transformation prong because "[t]he mere manipulation or reorganization of data ... does not satisfy the transformation prong." See CyberSource, 654 F.3d at 1375. This conclusion indicates that even if computers simplify data gathering and computation functions, a claimed invention is nevertheless unpatentable if it may be entirely performed through mental processes.
Examining the Supreme Court and Federal Circuit precedent, as well as decisions in this Circuit, the Court concludes that, the '786 patent does not involve transformation.
The defendants' arguments to the contrary are not persuasive. Specifically, the defendants note that the Federal Circuit, in Bilski I, stated that "the transformation of ... raw data into a particular visual depiction of a physical object on a display was sufficient to render that more narrowly-claimed process patent-eligible" and that "the electronic transformation of the data itself into a visual depiction ... was sufficient." See Defs.' Mem. at 11 (quoting Bilski, 545 F.3d at 963 (referring to In re Abele, 684 F.2d 902 (C.C.P.A.1982))). Defendants' reliance on Abele is misplaced. In Abele, the patent applicant sought to patent a process for improving the accuracy and reliability of CAT scan imaging techniques, while simultaneously reducing the X-ray exposure of the patient. Abele, 684 F.2d 902, 903 (C.C.P.A.1982). This process of improving imaging is very different than the data manipulation at issue here. Unlike in Abele, the patents here do not manifest any sort of physical transformation, and therefore do not satisfy the transformation prong of the MOT.
A claimed method may still constitute eligible subject matter despite failing to satisfy the MOT test. See Bilski II, 130 S.Ct. at 3226. The defendants assert that the MOT test is "disfavored," and that the Court should instead be guided by the Federal Circuit's reasoning in Ultramercial, LLC v. Hulu, LLC, 657 F.3d 1323, 1329 (Fed.Cir.2011). Defs.' Mem. at 8. An examination of this Federal Circuit precedent, however, only reaffirms that the defendants' patents-in-dispute are abstract and do not constitute patent eligible subject matter.
In Ultramercial, the Federal Circuit held that a patent claiming a method for "distributing copyrighted products (e.g. songs, movies, books) over the Internet where the consumer receives a copyrighted product for free in exchange for viewing an advertisement, and the advertiser pays for the copyrighted content," constituted patentable subject matter. 657 F.3d at 1324. The Federal Circuit upheld the patent-eligibility of the mechanism, concluding that this patent "does not claim a
While the claims in Ultramercial could not be performed as "purely mental steps," and involved a number of steps, with complex computer programming, the defendants' claimed inventions can be performed — and, in fact, are routinely performed — in the minds of physicians who are evaluating patients and selecting therapeutic treatment options for them. The patents-in-dispute are thus more like the claimed invention in CyberSource — a process for detecting credit card fraud in Internet transactions — which the court concluded could be performed exclusively in the human mind. See CyberSource, 654 F.3d at 1373. As in CyberSource, the claims at issue involve the "organization of data" and do "not require the method to be performed by a particular machine ..." Id. at 1370. The claims thus suffer from the same defects as the claims in CyberSource and are not patentable.
The Federal Circuit's recent decision in Dealertrack only reinforces that the patents-in-dispute are not patentable. There, the Federal Circuit found that a process for automating credit applications by receiving credit applicant data from a source and then forwarding the data to potential creditors and forwarding the reply data to the first source, constituted ineligible patent subject matter because it sought to "`[explain] the basic concept' of processing information through a clearing-house, just as claim 1 in Bilski II `[explained] the basic concept of hedging.'" Dealertrack, Inc. v. Huber, 674 F.3d 1315, 1333 (Fed. Cir.2012) (quoting Bilski II, 130 S.Ct. at 3231). The Federal Circuit held that the claim was abstract because the method did not "impose meaningful limits on the claim's scope." Id. at 1333 (quoting Bilski I, 545 F.3d at 961-62). In so holding, the Federal Circuit rejected the assertion that a computer was critical to the process because "the computer here `can be programmed to perform very different tasks in very different ways[.]'" Id. at 1333 (quoting Aristocrat Techs. Australia Pty Ltd. v. Int'l Game Tech., 521 F.3d 1328, 1333 (Fed.Cir.2008)). Thus, "it does not play a significant part in permitting the claimed method to be performed." Id. (citations and quotation marks omitted). The Federal Circuit found the patent invalid because the claims were "silent as to how a computer aids the method, the extent to which a computer aids the method, or the significance of a computer to the performance of the method." Id. at 1333. In addition, the claims did "not require a specific application" nor were they "tied to a particular machine." Id. at 1333-34.
In light of this precedent, the Court finds that the defendants' claims mirror the mental processes that a physician performs, and therefore embody the "`basic tools of scientific and technological work' that are free to all men and reserved exclusively to none." CyberSource, 654 F.3d at 1373 (quoting Benson, 409 U.S. at 67, 93 S.Ct. 253). Furthermore, the computing device references in the defendants' patents may be "programmed to perform very different tasks in very different ways," and therefore cannot serve as a significant limitation or constraint on the claimed invention. Dealertrack, 674 F.3d
Finally, while it is not necessary for this Court to formally construct the claims, the Court notes that the defendants' proposed construction of the disputed claims only reinforces that the defendants' claims are unpatentable. The claimed steps of the invention, and not the specification, must "impose meaningful limits on the claim's scope," see Bilski I, 545 F.3d at 961-62, in order to cabin the claimed invention's potential reach. The claim language in Claim 1 of the '786 patent fails to enforce any meaningful limits on the scope and breadth of the claimed invention. The defendants propose, for example, that the term "patient information" in Claim 1 of the '786 patent needs no definition. While SmartGene proposes constructing the claim "patient information" to include "gender, age, weight, CD4+ cell information, hemoglobin information, neuropathy information, neutrophil information, pancreatitis, hepatic function, renal function, drug allergy and intolerance information, information for drug treatments for other conditions, historical information on prior therapeutic treatment regimens for a disease or medical condition, and prior patient information," the defendants insist that the plain language of the claim should apply. Defs.' Cl. Constr. Br. at 2. Likewise, SmartGene proposes that the term "knowledge base" be narrowly constructed to, at a minimum, limit the three databases to human medical information.
For the reasons discussed above, this Court finds that the defendants' Patent Nos. 6,081,786 and 6,188,988 B1 constitute ineligible subject matter under 35 U.S.C. § 101, and are therefore invalid. Accordingly, SmartGene's Motion for Partial Summary Judgment, ECF No. 47, is granted. Since the patents at issue are invalid, the remaining claims and counterclaims pending in the suit are dismissed. An Order consistent with this Opinion shall be filed.