EDWARD J. DAVILA, District Judge.
Plaintiff Cave Consulting Group, Inc. ("Cave") brings this suit against Defendant Ingenix, Inc. ("Ingenix") for infringement of U.S. Patent No. 7,739,126 ("the `126 patent"). Ingenix denies infringement, and raises counterclaims alleging infringement of eight of its patents: U.S. Patent Nos. 5,835,897 ("the `897 patent"); 6,370,511 ("the `511 patent); 7,620,560 ("the `560 patent"); 7,774,216 ("the `216 patent); 7,725,333 ("the `333 patent"); 7,979,290 ("the `290 patent); 7,222,079 ("the `079 patent"); and 7,774,252 ("the `252 patent").
The parties dispute the proper construction of ten terms used in the claims of these patents. The court held a technology tutorial and claim construction hearing on August 9, 2012. Upon consideration of the claims, specifications, prosecution histories, and other relevant evidence, along with supplemental briefing filed by the parties, and after hearing the arguments of the parties, the court construes the contested language of the patents-in-suit as set forth below.
The parties are competitors offering healthcare provider efficiency measurement software to the healthcare industry. The patents-in-suit relate to the sorting of healthcare claims data into meaningful groups and using those groupings to evaluate physician efficiency. Ingenix's technology, the Symmetry Episode Treatment Grouper ("Symmetry ETG") is based on the patents of two inventors: Dennis Dang and Jerry Seare. Ingenix Opening Br. 1-2, Dkt. No. 66. The Dang and Seare patents focus on sorting massive healthcare data into meaningful groups based on appropriate time windows.
Claim construction is a question of law to be decided by the court.
Claims may be construed using both intrinsic and extrinsic evidence. Intrinsic evidence includes the language of the claims themselves, the patent specification, the prosecution history, and any other statements made by the patentee to the United States Patent and Trademark Office regarding the scope of the invention. Extrinsic evidence includes dictionaries, technical treatises, and testimony from experts or inventors. Extrinsic evidence may be used if the sources are "helpful in determining the true meaning of language used in the patents."
The `126 patent uses "marketbaskets" to evaluate physician efficiency. Each category of physician has its own marketbasket which reflects the universe of medical conditions that a physician of that specialty is most likely to treat. Cave Reply Br. 6, Dkt. No. 71. Each medical condition is assigned a weight, which reflects the prevalence of that condition in that particular marketbasket.
The parties dispute whether these assigned weights,
Ingenix contends that the nine dependent claims relying on direct standardization have no support in the specification, and thus the doctrine of claim differentiation should not preclude the court from construing "weighted episode of care statistics" to be limited to indirect standardization. Dr. Cave filed his patent application for the `126 patent on March 5, 2004. Several years later, on October 22, 2009, Dr. Cave filed an amendment that,
Ingenix highlights this background not to argue that Dr. Cave disclaimed direct standardization in the prosecution history,
First, Ingenix contends that Dr. Cave's criticism of direct standardization precludes the court from broadening the construction of this term beyond predetermined weight factors. Ingenix points to the fact that the original `126 patent application did not include any claims or preferred embodiments that relied on direct standardization, and in fact only referenced that method in the form of criticism in the "Background of the Invention" section. Generally, "when the scope of the invention is clearly stated in the specification, and is described as the advantage and distinction of the invention, it is not necessary to disavow explicitly a different scope."
Second, Ingenix points to Dr. Cave's statement that "[t]he system of the present invention uses an indirect standardization technique" to suggest that Dr. Cave intended to exclude direct standardization from the scope of his claims. `126 patent 92:36-37. While a patentee's statement that a certain feature is part of the "present invention" can provide "strong evidence that the claims should not be read to encompass the opposite structure," (
"Quite apart from the written description and the prosecution history, the claims themselves provide substantial guidance as to the meaning of particular claim terms."
The court adopts Cave's construction. "Weighted Episode of Care Statistics" shall mean "cost or length of care statistics for a group of medical conditions calculated using the relative importance of each condition to the others of the group."
The term "determining eligible physicians and episode of care assignments" is found in both the claims and the specification of the `126 patent. Cave argues that this term is "nuanced" and that construction is necessary "to help the jury understand the functionality of Dr. Cave's inventive method." Dkt. No. 64 at 12. Ingenix maintains that the plain meaning should apply because Cave's proposed construction is an attempt to re-write the claim term and would render other claim language superfluous.
A claim term generally is given its ordinary and customary meaning as it would have been understood by a person of ordinary skill in the art in question at the time of the invention.
Each time the term appears, it is immediately followed by an explanation of how it operates. For instance, the term appears as the title of Step 13 in the patent specification. By the time this step is performed, claims data has already been grouped into episodes of care and those episodes have been assigned to treating physicians. `126 patent 50:48-51:38, 66:15-68:16. Step 13 provides:
Similarly, the term is explained in Claim 1 of the `126 patent, which recites
Determining eligible physicians and episode of care assignments utilizing the computer system comprising:
`126 patent 109:29-33.
And again, in Claim 9 of the `126 patent:
The method in claim
`126 patent 110:1-8.
The thorough explanations that immediately follow whenever this term appears resolve the parties' dispute.
Given the consistent explanation of this term throughout the `126 patent, the court finds that the jury will likely not be confused by its plain meaning. Indeed, additional construction could render the term more confusing by requiring the jury to cross reference the court's construction with the explanations already provided in the patent. Therefore, the court agrees with Ingenix and declines to construe this term. The ordinary meaning of the term "determining eligible physicians and episode of care assignments" shall apply.
The term "maximum duration rule" appears in the `126 patent and describes a rule that controls the duration of episodes of care. Ingenix argues that the plain meaning of the term should be applied because the jury will not be confused by the words "maximum," "duration," or "rule." Dkt. No. 66 at 22. Cave contends that the plain meaning of the term does not accurately capture its meaning.
"In some cases, the ordinary meaning of claim language ... may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words."
Ingenix argues that Cave's proposed construction is improper because it strips out the requirement that the maximum duration rule be based on a "maximum" length of time, and broadens the term to include any time-based rule. Cave does not directly address this argument, but asserts that "the maximum duration rule can define episodes of care based on either a fixed or dynamic time window" and that "the maximum allowable duration may be varied." Dkt. No. 71 at 13 (quoting `126 patent 51:35-38). While these statements are accurate, they do not disprove the assertion that "maximum" durations, and not simply time-based durations, are at issue in this term. Based on the patent specification and claims, the court has determined that a "time-based rule" is too broad a construction for this term.
As the patent specification and claims make clear, the maximum duration rule is used to control the formation of episodes of care based on the maximum number of days in a predetermined time window. The patent specification provides that "a medical condition's window period is based on the
The method of claim
As used in this claim, the maximum duration rule limits an episode of care to a prespecified window and restricts adding other claims to that episode of care outside of the prespecified window. The use of the maximum duration rule thus depends on a maximum number of days assigned to each medical condition and this concept must be included in the term's construction.
Ingenix also argues that Cave's inclusion of the grouping of claims data into episodes of care in the construction of this term is improper because such grouping is expressly addressed in separate claim language. Cave argues that the specification and claims make clear that the "maximum duration rule" is used to regulate the formation of episodes of care, and thus to understand the term, this language must be included in the construction. The court agrees with Cave. This term cannot be properly understood without a reference to its use in building episodes of care because that concept appears to be inextricably entwined with the rule itself. Thus, the inclusion of grouping in the term's construction is proper.
The court adopts a modified version of Cave's construction. "Maximum Duration Rule" shall mean "rule based on a maximum time period(s) that is used to group claim data pertaining to a patient's medical condition(s) into an episode(s) of care."
The term "validate" and variations thereof appear at least in Claim 1 of the `897 patent ("(b) validating each of the at least one of a plurality of data records for at least one of a diagnosis code and a treatment code" and "(d) grouping the validated at least on of a plurality of data records to an episode treatment category based upon the pre-defined relationship") and Claim 1 of the `511 patent ("(b) validating each of the at least one of a plurality of data records for a valid drug code."). Ingenix argues that "validate" is not a term of art and therefore does not require construction. Cave argues that the plain meaning of the term would be misleading to the jury, as it is divorced from the context of the invention. Cave proposes three limitations to the term validate: 1) look-up tables, 2) a predetermined relationship between a particular diagnosis code and a particular treatment code, and 3) a discontinuation of the process for invalid claim data. The court will look at each of these limitations in turn.
First, Cave argues that because the patent specification teaches that look-up tables are used to verify the relationship between diagnosis and treatment codes, the construction of validate must include look-up tables. Ingenix argues that use of look-up tables is simply described as a preferred embodiment, and that including a reference to look-up tables in the construction of validate would improperly narrow the scope of its claim.
While the specification is "always highly relevant,"
Here, the patentee showed no clear intention to limit the claim scope to a validation process using only look-up tables. The patent specification teaches the use of look-up tables as a preferred embodiment, but neither the specification nor the file history suggests that look-up tables comprise the exclusive embodiment. Nor has Cave pointed to any evidence supporting its assertion that the data can be verified only by reference to look-up tables. To construe validate to include a reference to look-up tables thus would be to include an unnecessary limitation, based on the preferred embodiment, in the construction of this term. This court declines to do so.
Second, Cave asserts that the treatment and diagnosis codes in the medical claims data are validated on the basis of a predetermined relationship between those codes, and that validate cannot be properly understood without including these predetermined relationships in its construction. Ingenix argues that the language teaching those predetermined relationships flows not from validate, but from the language later in the claim, and thus that including predetermined relationships in the construction of validate would impose improper limitations on the term.
Step (b) of Claim 1 describes the validating step: "validating each of the at least one of a plurality of data records for at least one of a diagnosis code and a treatment code." As Ingenix points out, the predetermined relationships appear in the following step, step (c) of Claim 1: "reading at least one pre-defined relationship between the at least one of a diagnosis code and a treatment code." From the language and order of the claim, it does not appear that a predetermined relationship is necessary to the validation step described in step (b). Rather, the predetermined relationship is read after the validating step is performed. Because the relationship flows from a separate step in the claimed methods, it would be improper to conflate the two by including predetermined relationships in the construction of validate.
Including predetermined relationships between treatment and diagnosis codes in the construction of validate would also be improper because it would create inconsistent meanings of the term across the patent family. Claim 1 of the `551 patent covers "(b) validating each of the at least one of a plurality of data records for a valid drug code." Validate, as used in this claim, does not relate to treatment and diagnosis codes, but rather to drug records. Cave proposes an alternative construction for validate as it appears in the `511 patent: "verifying through look-up tables whether a particular drug code can be assigned to an open episode treatment group, and discontinuing the processing of any drug codes that cannot be so assigned." Construing the same term in two different ways would not only be unnecessarily confusing but also inappropriate. The `511 patent and `897 patent are members of the same patent family. Dkt. No. 66 at 4. Given this relationship among the patents, the court should construe the terms consistently across the entire patent family.
Third, Cave argues that because the patent teaches that unvalidated claim records are not processed, the termination of processing of unverified claims data must be included in the construction of validate. Ingenix asserts that in doing so, Cave is attempting to append an entirely separate step into a simple claim term.
The parties both point to Figure 3 of the `897 patent:
The specification describes this figure as "a flow diagram illustrating an Eligible Record Check routine which validates and sorts patient claim data records." `897 patent 8:9-11. According to this figure, validation occurs at step 104, and discontinuation of invalid records occurs at step 113. The figure also depicts a number of other steps, including steps relating to loading the claims data into the system (step 102), and the process to follow for valid claims data (steps 106, 110, 112, 120).
It is clear that this figure describes an entire process, of which validation is only one part. Cave does not suggest that this court import other steps such as loading claims data or processing of validated records into the construction of "validate." Yet Cave insists that including the discontinuation step is essential to the construction of this term. Cave fails to explain why it has selectively suggested including the discontinuation step while ignoring others. This court finds that it would be wholly inappropriate to selectively import the discontinuation step into the construction of validate. Doing so would result in a bloated, misleading construction of an otherwise straightforward term.
The court agrees with Ingenix that no further construction of the term validate is necessary. The word validate connotes a process of checking to ensure something is valid or acceptable. As used in the claims, validate means nothing more than its plain meaning. The term is thus sufficiently clear, and the court will not construe it.
The `897 patent family's invention addresses changes in clinical condition through shifting. The term "shift" is found in several claims of the `897 patent family, including dependent Claim 23, which recites "shifting a medical episode to a different medical episode treatment category based upon changes in patient condition comprising at least one of comorbidity, complication and defining surgery." Ingenix argues that the plain meaning of shift is sufficient to understand the claim language. Cave argues the plain meaning ignores that shifting only occurs when the next claim line item indicates a change in clinical condition, and that that change is from a "first" clinical condition to a "second" one.
To support its suggested limitations, Cave points to several portions of the prosecution history in which Mr. Dang, the inventor, describes shifting as moving an episode from one episode treatment group to another based on later presented claims data. Particularly, the prosecution history contains the following descriptions:
The court agrees with Cave that shifting cannot be understood without a reference to changing clinical conditions. However, the court disagrees with the specific limitations that Cave proposes. Neither the claim language nor the prosecution history demonstrate that the triggering event need be anything more than later claims data showing a change in clinical condition. Cave does not present evidence that the claims data is already sorted in any particular fashion that would make the "next" claim line item and only the "next" claim line item meaningful. Cave's suggestion that shifting is triggered by "the next claim line item" thus presents too narrow a limitation.
Similarly, Cave's proposal that shifting occurs from "a first to a second clinical condition" reads too much into the descriptions of shifting found in the claim language and prosecution history. These descriptions merely reference a shift from one clinical condition to another. The "first" and "second" limitations therefore have no support within the file history.
The court adopts a modified version of Cave's construction. "Shift/Shifted/Shifting" shall mean "when later processed claims data indicates a change from one clinical condition to another, the episode is moved to the later clinical condition."
The term "reset" appears throughout the Dang patents and describes a way of increasing the period of time assigned to an episode. Ingenix argues that the term has a clear meaning, and therefore no construction is necessary. Cave argues that the plain meaning of reset would be misleading, because the term applies particularly to a slide in the predefined time window based on a change in claims data. To address this concern, Cave proposes adding two limitations to the construction of reset, namely, a triggering event and a predefined time period.
Ingenix' technology assigns a time period to each episode. For example, claims data reflecting treatment for an upper respiratory infection is grouped to an episode assigned a 30 day time period. When later processed claims data is added to an episode, the time period for that episode "resets" to account for the new claims data.
When the later processed claims data shifts the episode of care to a more severe condition, the time period "resets" to the time period for the new condition. Continuing the upper respiratory infection example, if the patient with the upper respiratory infection visits his doctor again on day 17 and is treated for pneumonia, the episode would reset to 90 days,
When the later processed claims data adds another claim to the episode but does not shift the episode to a more severe condition, the time period also resets to 0, but restarts the originally assigned time period.
The court must determine whether the ordinary meaning of reset is sufficient, or whether to construe this term using the limitations suggested by Cave. Cave first proposes including the triggering event for a reset in the construction of the term. Specifically, Cave proposes the limitation of "[w]hen the next claim line item processed has a date of service within the defined time period and associated with the episode." Ingenix argues that adding a triggering event to the construction of reset would be improper because the triggering event is expressly covered by other claim language. For example in Claim 1 of the `560 patent, the triggering event is specified as "when later presented medical claim data having the at least one characteristic of the episode of care and falling within the first clean period is added to the episode of care." Similarly, Claim 21 of the `897 patent adds the "step of resetting the predefined time window of the medical episode
Cave next proposes that reset requires construction to explain the concept of starting a predefined time period over. Both parties agree that "reset" means to start a time period over. But they disagree on the inclusion of a predefined time period in the term's construction. Again, other claim language makes clear that the time period for the later processed claims data is predefined.
The court agrees with Ingenix that the plain meaning of "reset" is sufficient. As the parties agree, to reset is to start over. The claims use this term in the way suggested by its plain and ordinary meaning. Therefore, the court declines to construe this term.
The dynamic time window is the backbone of Ingenix' technology. Prior to Mr. Dang's invention, the ETG Program was not capable "of accurately grouping claims to clinically homogeneous and statistically stable episode treatment groups and shifting the groupings for changed clinical conditions as would be required by healthcare providers." JA 561, Dang Aff. ¶ 4. By creating "dynamic time windows," in which the episode's time period could change based on changes in in the medical claims data, Mr. Dang was able to more accurately capture the length of a patient's treatment for a certain clinical condition. While the parties agree that in essence, a dynamic time window is a time period assigned to an episode that can change, they disagree as to how that change should be captured in the term's construction. Particularly, the parties dispute whether the concepts of shifting and resetting need be included in the construction of dynamic time window.
Cave argues that Mr. Dang explicitly included shifting as an inseparable element of the dynamic time window in order to skirt around the on-sale bar issue during patent prosecution. To support its assertion Cave points to the following portions of the `897 patent file history:
As reflected in these citations, the inventor and his counsel indisputably address shifting and the dynamic time window together. However, Cave's reading of the file history is flawed because it conflates the two concepts. The file history makes clear that while shifting can facilitate a dynamic time window, it is not necessary. In the first section above cited by Cave, Mr. Dang's attorney explained that Mr. Dang conceived of the "concepts" of "dynamic time windows" and "shifting episodes upon changes in the clinical condition." The pluralization of "concepts" implies that dynamic time windows and shifting are not one in the same. Nor are they inextricably linked. In the third citation above, Mr. Dang's attorney explains that the invention "first" groups each claim record, and then "potentially shifts" the episode "if" a later record warrants it. The conditional language here makes clear that shifting is a step that can, but does not have to, occur when building episodes.
The patent specification also makes clear that the dynamic time window can be employed without a shift. For instance, in the case where a patient visits the doctor with an upper respiratory infection and is assigned to an episode of care having a 30 day period, but visits the doctor again for his respiratory infection on day 17, the time window resets to another 30 day period, creating a 47 day period total. In this scenario, no shift in clinical condition has occurred, but the time period has changed.
The dynamic time window does, however, facilitate shifting. In creating a way for the episode's assigned time period to change, "the dynamic time window allows for the shifting of an episode from one ETG to another ETG to reflect a patient's changed condition." JA 553. Taking again the example of the patient who visits the doctor with an upper respiratory infection and is assigned a 30 day time window, if that patient on day 17 visits his doctor with pneumonia, the time window changes to 90 days. This change in the time window allows for a shift in episode from upper respiratory infection to pneumonia. That the dynamic time window facilitates shifting, a separate feature of the technology, is nevertheless insufficient to support Cave's argument that shifting is a necessary component to the construction of dynamic time window.
It is not quite as simple, however, to separate the concept of resetting from the concept of the dynamic time window. For the dynamic time window to be "dynamic," it has to change. That change, as described in the file history and as practiced in Ingenix' product, occurs through the resetting of time periods assigned to episodes when additional claims data so requires. Counsel for Ingenix suggests that a time window may be dynamic in ways apart from resetting, presenting the example of an insurance company that would like to assign different time periods to sequential office visits such that the first visit receives a 30 day time period, the second visit 20 days, and the third visit 15 days. Tutorial/Markman Hr'g Tr. 48:10-19, Aug. 9, 2012, Dkt. No. 82. While the court recognizes that this kind of dynamic time window may be possible, it disagrees with Ingenix that the file history supports this broader reading. Mr. Dang and his attorneys repeatedly referred to the time window as being "dynamic" because of its ability to reset.
The court adopts a modified version of Ingenix' construction. "Dynamic Time Window" shall mean "a time period that can reset based upon receipt of related claim records within a predefined time period."
The term "episode of care" appears in both the Seare patents and the Cave patent. The parties agree that the term should be construed in connection with the Ingenix patents, and that the construction should be the same for the Cave patent.
When a patentee acts as his own lexicographer and clearly sets forth a definition of a disputed claim term in the specification or the prosecution history, that express definition governs.
Cave argues that despite this evidence, using healthcare services instead of claims data as the anchor of the term's construction would result in a construction completely divorced from the context of the invention. Because claims data—not healthcare services—actually build the episodes of care, Cave argues, claims data must also be the basis of the term's construction. The intrinsic record here does not support Cave's assertions. The inventor clearly expressed a definition for this term. He included it as part of the patent specification, and quoted that same definition in a response to the PTO. In both instances, the inventor defined the term episode of care by the healthcare services a patient receives. Accordingly, "episode of care" shall be construed using healthcare services.
The court adopts Ingenix' construction. "Episode of Care" shall mean "A group of all healthcare services provided to a patient for the diagnosis, treatment, and aftercare of a specific medical condition(s) within a period of interest."
The term "episode treatment group" ("ETG") appears throughout the claims of the Dang patents and describes the basic analytical unit of the Dang invention. `897 patent, 6:13-19. The `897 patent specification states that "[a]n episode treatment group (ETG) is a clinically homogeneous and statistically stable group of similar illness etiology and therapeutic treatment." `897 patent, 6:17-19. This description appears similar to that of an episode of care, a term found in both the Seare and the Cave patents, which is "all healthcare services provided to a patient for the diagnosis, treatment, and aftercare of a specific medical condition." `079 patent, 21:3-6. Ingenix contends that the two concepts are separate. Cave believes them to be identical.
Ingenix emphasizes that an episode treatment group is defined as a group of medical
The first entry on this table, for example, is ETG 1 — "AIDS with major infectious complication." That entry and all that follow it describe clinical conditions, rather than the services provided to the patient for treatment of a clinical condition. In contrast, as discussed in the previous section, an episode of care describes the collection of treatments a patient receives for a certain clinical condition.
Cave argues that, despite the difference in definitions, the two concepts are functionally the same. For instance, Cave points to Claim 3 of the `897 patent, which states:
While the claimed processes use the same building material (patient records), the final products (episode treatment groups and episodes of care) are not the same. It is clear from the patent language that the process claimed in the Dang patent produces an analytical unit defined by medical conditions, and the process claimed in the Seare patents and used in the Cave patent produces a unit defined by medical services.
Furthermore, the two concepts have already been distinguished in the `079 patent file history. The `079 patent, which utilizes episodes of care, describes the use of "Index Codes." In a response to the PTO dated January 25, 2002, Seare, the inventor, described the creation of episodes of care as relying on Index Codes stating:
Seare went on to compare these Index Codes to the episode treatment groups found in the Dang patents:
Seare certainly understood the concept of episodes of care, and clearly separated that concept from episode treatment groups. Based on this description, if episode treatment groups are identical to anything, it would be Index Codes, not episodes of care. The court therefore declines to conflate the two concepts in its construction.
The court adopts Ingenix' construction. "Episode Treatment Group" shall mean "a group of medical condition(s) that have clinically similar cause(s), treatment(s) and/or diagnos(es )."
The term "episode treatment category" appears in both the Dang `897 patent and the Seare `079 patent file history. Claim 1 of the `897 patent provides:
The `079 file history explains that an episode treatment category is a "designator for a particular medical diagnosis or condition, e.g. acute bronchitis." JA 1881.
Cave proposes adding two limitations to the term episode treatment category. First, Cave proposes that the medical conditions must be predefined. Second, Cave proposes limiting the term's construction to a "table" defining the relationship between treatment codes and diagnoses.
The court declines to adopt Cave's interpretation for similar reasons to those set forth in other sections of this Order. Particularly, other claim language makes sufficiently clear that episode treatment categories are made based on predefined relationships.
The court adopts Ingenix' construction. "Episode Treatment Category" shall mean "a classification that includes one or more Episode Treatment Groups"
