MEMORANDUM & ORDER
On October 14, 2005 plaintiff Board of Trustees of the Leland Stanford Junior University (“plaintiff’ or “Stanford”) brought this action against Roche Molecular Systems, Inc., Roche Diagnostics Corporation, Roche Diagnostics Operations, Inc., and Roche Diagnostic Systems, Inc. 1 *971 (collectively “defendants” or “Roche”) alleging infringement of U.S. Patents Nos. 5,968,730 (“the '730 patent”) and 6,503,705 (“the '705 patent”). On November 17, 2005 Roche filed a counterclaim against Stanford, naming Dr. Thomas Merigan as an additional counterclaim defendant. In June 2006, Roche amended its counterclaim without objection to add Dr. Mark Holodniy as a counterclaim defendant. On March 26, 2007, Stanford amended its complaint to also allege infringement of U.S. Patent No. 7,129,041 (“the '041 patent”). Now before the court are the parties’ claim construction briefs, filed pursuant to Patent Local Rule 4-5. Having considered the parties’ arguments and submissions, and for the reasons set forth below, the court construes the disputed terms as follows.
BACKGROUND
This patent dispute concerns the application of Polymerase Chain Reaction (“PCR”) technology in the context of research related to the Human Immunodeficiency Virus (“HIV”) and the Acquired Immunodeficiency Syndrome (“AIDS”). Stanford currently owns three patents titled “Polymerase Chain Reaction Assays for Monitoring Antiviral Therapy and Making Therapeutic Decisions in the Treatment of Acquired Immunodeficiency Syndrome.” The patents involve correlating measurements of HIV nucleic acids obtained via a PCR assay with determining whether or not a therapy is effective. The results can also be helpful in determining whether the patient has developed a strain of HIV that is resistant to the particular therapy the patient is undergoing.
Claims 1, 5-9, 13-14, 18-19, and 23 of the '730 patent; Claims 1 and 5-10 of the '705 patent; and Claims 1-4 and 8 of the '041 patent are asserted in this litigation. In general, there are two types of method claims in these patents. The first type includes a step for measuring the HIV copy number. See '730 patent, Claims 9, 14, and 19; '705 patent, Claims 1 and 8. Claim 9 of the '730 patent reads:
9. A method of evaluating the effectiveness of anti-HIV therapy of a patient comprising
(i) collecting a plasma sample from an HIV-infected patient who is being treated with an antiretroviral agent;
(ii) amplifying the HIV-encoding nucleic acid in the plasma sample using HIV primers in about 30 cycles of PCR; and
(Hi) measuring the HIV RNA copy number using the product of the PCR, in which an HIV RNA copy number greater than about 500 per 200 ul of plasma correlates positively with the conclusion that the antiretroviral agent is therapeutically ineffective.
Similarly, Claim 1 of the '705 patent reads:
1. A method of evaluating the effectiveness of anti-HIV therapy of an HIV-infected patient comprising:
a) collecting statistically significant data useful for determining whether or not a decline in plasma HIV RNA copy numbers exists after initiating treatment of an HIV-infected patient with an antiretroviral agent by:
(i) collecting more than one plasma sample from the HIV infected patient at time intervals sufficient to ascertain the existence of a statistically significant decline in plasma HIV RNA copy numbers;
(ii) amplifying the HIV-encoding nucleic acid in the plasma samples using HIV primers via PCR for about 30 cycles;
(Hi) measuring HIV RNA copy numbers using the products of the PCR of step (ii);
*972 (iv) comparing the HIV RNA copy numbers in the plasma samples collected during the treatment; and
b) evaluating whether a statistically significant decline in plasma HIV RNA copy numbers exists in evaluating the effectiveness of anti-HIV therapy of a patient.
The other type of method claims do not include a measuring step, but instead include a step testing for the presence or absence of detectable HIV-encoding nucleic acid. See '730 patent, Claims 1, 6, 7, and 8; '041 Patent, Claim 1. Claim 1 of the '041 patent reads:
1. A method of evaluating the effectiveness of anti-HIV therapy of a patient comprising correlating the presence or absence of detectable HIV-encoding nucleic acid in a plasma sample of an HIV infected patient with an absolute CD4 count, wherein the presence or absence of said detectable HIV-encoding nucleic acid is determined by
(i) collecting a plasma sample[ ] from an HIV-infected patient who is being treated with an antiretroviral agent;
(ii) amplifying HIV-encoding nucleic acid that may be present in the plasma sample using HIV primers via PCR and;
(iii) testing for the presence of HIV-encoding nucleic acid sequence in the product of the PCR.
The present dispute boils down to four specific terms which are used in various contexts throughout the patents. The terms are: 1) “therapeutically effective” or “therapeutically ineffective”; 2) “an antire-troviral agent”; 3) “measuring the HIV RNA copy number”; and 4) “presence of detectable HIV-encoding nucleic acid” or “absence of detectable HIV-encoding nucleic acid.”
LEGAL STANDARD
I. Claim Construction
Under
Markman v. Westview Instruments, Inc.,
Among the sources of intrinsic evidence, the specification is “the single best guide to the meaning of a disputed term.”
Vitronics Corp. v. Conceptronic, Inc.,
90 F.3d- 1576, 1582 (Fed.Cir.1996). By expressly defining terms in the specification, an inventor may “ehoose[ ] to be his or her own lexicographer,” thereby limiting the meaning of the disputed term to the definition provided in the specification.
Johnson Worldwide Assocs., Inc. v. Zebco Corp.,
Likewise, the prosecution history may demonstrate that the patentee intended to deviate from a term’s ordinary and accustomed meaning.
Teleflex,
Dictionary definitions and other objective reference materials available at the time that the patent was issued may also provide evidence of the ordinary meaning of a claim.
Phillips v. AWH Corp.,
Federal Circuit decisions take a less favorable view of other forms of extrinsic evidence, such as expert testimony and prior art not cited in the specification or the prosecution history, noting that “claims should preferably be interpreted without recourse to extrinsic evidence, other than perhaps dictionaries or reference books, and that expert testimony should be received only for the purpose of educating the judge.”
EMI Group N. Am., Inc. v. Intel Corp.,
The Federal Circuit recently revisited the basic approach to claim construction in Phillips. Although Phillips consists largely of an affirmation of ten years of claim construction jurisprudence, it provides at least two pieces of additional guidance. First, the Federal Circuit rejected a line of cases suggesting that claim interpretation must begin with a dictionary definition of the disputed terms. Phillips, 415 F.3d at 1320-21. Second, the Federal Circuit emphasized that claim terms must be interpreted in light of their context, especially the language used in other claims and the specification. Id. at 1321. Taken as a whole, Phillips appears to signal a small retreat from formalism and bright-line rules in claim construction. As a result, the court will focus primarily on the intrinsic record before it. Cases cited by the parties in support of fixed “rules” of claim construction will accordingly be given somewhat less weight.
DISCUSSION
I. Level of Ordinary Skill
“Factors that may be considered in determining level of ordinary skill in the art include: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.”
Envtl. Designs, Ltd. v. Union Oil Co.,
Stanford claims that a person of ordinary skill in the art is a medical doctor working on clinical HIV research involving antiretroviral agents or a Ph.D. researcher working on molecular methods relating to clinical HIV research involving antiretrovi-ral agents. Roche claims that a person of ordinary skill in the art is one with a medical degree or graduate degree in biochemistry or a related field and who has had at least two years of relevant laboratory bench experience conducting PCR assays.
The art involved in these patents is the use of PCR assays to determine HIV viral load in a sample so that the information may be used to determine the effectiveness of the antiretroviral therapy regimen that the sample is undergoing. There does not seem to be a significant difference between the parties’ competing formulations except for Stanford’s requirement that one of skill have experience with antiretroviral agents. A medical doctor without experience with antiretroviral agents would not have the level of ordinary skill required because the patents in question relate directly to the effectiveness or ineffectiveness of antiretroviral agents.
The individuals included in Stanford’s definition will certainly have experience with antiretroviral agents, but may or may not be experienced in conducting PCR assays. The patents at issue, however, all relate to the use of PCR assays used to generate data for the purpose of evaluating the effectiveness of anti-HIV therapy. Since knowledge of PCR assays is a prerequisite to understand, let alone practice, the patents in question, the court is convinced that knowledge of PCR assays is required.
The person of ordinary skill is thus defined as: A medical doctor working on clinical HIV research involving antiretrovi-ral agents or a Ph.D. researcher working on molecular methods relating to clinical HIV research involving antiretroviral agents. Any person of ordinary skill in the art must have conducted numerous *975 PCR assays in conjunction with his research.
11. Discovery Abuses
Roche claims two instances of discovery abuse by Stanford, each related to one of Stanford’s two experts. First, that Stanford improperly failed to make its expert Dr. Kramer available for deposition, and second, that Stanford improperly instructed its expert Dr. Volberding not to answer certain questions during his deposition.
On August 2, 2007 the court issued an order regarding expert depositions in conjunction with claim construction. See Docket No. 175. The court stated that the expert’s deposition could be canceled if either party did not intend to rely upon the testimony of that expert in its briefing. Id. Soon thereafter, Stanford informed Roche that Dr. Kramer’s August 15, 2007 deposition was being can-celled because it did not intend to use his testimony in its opening brief. See Docket No. 184, Exhs B & D; Rhyu Supp. Dec., Exh. 32. Nonetheless counsel for Roche traveled to Boston to take the deposition. See generally Kramer Dep. On August 15, 2007 this court ruled that if Stanford intended to rely on Dr. Kramer’s testimony, it would have to make him available for deposition if requested by Roche. See Docket No. 186. Stanford did not use Dr. Kramer’s testimony in any of its briefing and thus its actions were proper.
Stanford, however, did rely on Dr. Volberding’s opinion. Specifically, Dr. Volberding opined on the meaning of “therapeutically effective” and “therapeutically ineffective.” Volberding Dec., ¶¶ 7-12. Thus, in accordance with the court’s order, Mr. Volberding’s deposition was taken by Roche on August 19, 2007. At this deposition, counsel for Stanford did not let Mr. Volberding answer questions regarding which other parties, if any, cur-
rently make recommendations about HIV-therapy or its effectiveness for a particular patient. See Cannon Dec., Exh. A at 83:5-88:8. Roche requests, as a remedy, that the court strike Dr. Volberding’s declaration and that Stanford be precluded from challenging Roche’s construction of the terms “therapeutically effective” and “therapeutically ineffective.”
Roche claims that one hotly contested issue in this litigation is who performs the assay and who makes evaluations about effectiveness. It relies upon
Wilson Sporting Goods Co. v. Hillerich & Bradsby Co.,
Roche’s proposed construction relies on its argument that it is the physician, and nobody else, that makes evaluations about the overall effectiveness of an antiretrovi- *976 ral therapy. This, they claim, has been the case since May 1992. Since the objected to questions were within the scope of this construction, they were properly asked of Dr. Volberding. The court, with respect to claim construction, will therefore assume that Stanford has waived any argument regarding who makes decisions about whether a particular therapy is effective overall. Namely, for the purposes of claim construction, it will be considered admitted that the physician generally makes the decision regarding a particular therapy’s overall effectiveness.
III. Claim Construction
The following chart summarizes the court’s construction of the disputed terms. 2 The full analysis supporting each construction is below.
Term Construction
“therapeutically effective” or “therapeutically ineffective” No construction necessary.
“an antiretroviral agent” “At least one substance having or capable of having an effect against a retrovirus, such as HIV”
“measuring the HIV RNA copy number” No construction necessary.
“presence of detectable HIV-encoding nucleic acid” or “absence of detectable HIV-encoding nucleic acid” No construction necessary.
A. “Therapeutically effective” or “therapeutically ineffective”
Stanford claims that these terms need not be construed because the plain meaning of these terms is sufficiently clear. As stated above, the court must “indulge a ‘heavy presumption’ that a claim term carries its ordinary and customary meaning.”
CCS Fitness, Inc. v. Brunswick Corp.,
These terms do not need to be construed because they are neither unfamiliar to the jury, confusing to the jury, nor affected by the specification or prosecution history.
See United States Surgical Corp. v. Ethicon, Inc.,
Roche’s proposed constructions for “therapeutically effective” and “therapeutically ineffective” are: “elicits the medical effect intended by the treating physician such that the course of treatment is not modified” and “fails to elicit the medical effect intended by the treating physician as a result of drug resistance such that the course of treatment is modified.” These constructions do not address the ordinary and customary meaning of these terms and fail due to two specific flaws. First, Roche integrates a physician’s mental or subjective state, namely an intended medical effect into the construction. Roche also limits the construction to a particular physician — the “treating” one — not just any physician. Second, Roche requires a particular course of action by the physician.
Roche’s arguments combine three facts that are generally not in dispute. First, the only person who evaluates whether anti-HIV therapy for a patient is therapeutically effective or ineffective is the treating physician. Second, the patents in question relate to a decision about the effectiveness of the therapy. See Title of '730 patent. Third, the patent is silent as to what is therapeutically effective and ineffective. Thus, Roche contends, one of ordinary skill in the art would consider these terms to refer to the medical effect intended by the treating physician with respect to the prescribed treatment. Each premise is discussed below followed by a discussion of Roche’s conclusion.
First, Roche makes great attempts, both in its brief and its expert declarations, to demonstrate that the treating physician is the one who makes decisions regarding the patient’s drug regimen. There is little doubt that it is the treating physician who usually makes determinations regarding a patient’s treatment regimen and whether it is therapeutically effective. Neither Stanford nor the court disputes this. Indeed, the patent itself states that “[i]f a patient being treated with an antiretroviral therapeutic agent exhibits an increase in plasma HIV RNA copy number, a physician should consider altering the patient[’]s treatment regimen.” '730 patent at 2:45-49. The patent, however, does not limit itself to the treating physician. Therefore, the decision does not necessarily have to be made by the treating physician and could be made by other medical professionals.
Second, the patents are clear regarding their purpose — to determine if the given anti-retroviral regimen is aiding in the decrease of HIV viral load. The physician is told by the specification what should or should not be considered therapeutically effective. See, e.g., '730 patent Claim 1 (“the absence of detectable HIV-encoding nucleic acid correlates positively with the conclusion that the anti-retroviral agent is therapeutically effective.”). It is clear that physicians take multiple factors into account when determining whether a particular antiretroviral therapy is effective or not and the result of the patented method would be but one of those factors.
*978 Third, the patent is indeed silent as to what is to be considered therapeutically effective or ineffective. As discussed above, this ordinarily would be within the purview of the physician. The patents merely aid the physician in that determination by pointing her in the right direction — correlating certain results with effectiveness or ineffectiveness.
Roche wants the court to insert the physician’s state of mind into the construction. State of mind has been discussed by the Federal Circuit.
See Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
Roche attempts to distinguish
Amgen Inc. v. Hoechst Marion Roussel, Inc.,
Furthermore, the patent may be practiced by others not physicians. For instance, the method described in the patent may be practiced on old samples to track a patient’s viral load over time. They may even be practiced after patients are deceased in order to gather data regarding the effectiveness of a particular regimen on a large sample. Neither of these instances would require a physician’s ex-ante intent or the physician’s participation. The patents also describe identifying patients whose infection has become resistant to a particular anti-retroviral regimen. See, e.g., '730 patent at 1:21-25. The myriad ways in which the methods described in the patent can be practiced cautions against limiting the patent to the physician’s intent.
*979 Roche’s construction would also require that the course of treatment be modified or not modified for the treatment to be considered therapeutically effective or not. Physicians, however, may choose to modify a course of treatment even if they consider the treatment to be effective. Similarly, a physician may choose not to modify a course of treatment even if it is not effective. For instance, the physician may want to wait and see if the treatment might become effective over a longer period of time. Roche itself states that physicians analyze multiple factors when determining a particular course of treatment. Bartlett Dec., ¶28 (listing baseline resistance of patient’s HIV strain, side effects, concurrent conditions, and patient preference as factors); see also Opp. Br. at 8. Thus, whether the treatment is modified or not does not necessarily demonstrate whether the treatment is therapeutically effective or not. This rationale applies equally as forcefully to the intended medical effect limitation because achieving or not achieving the intended medical effect does not necessarily determine whether a treatment is effective or not.
Reading the terms in context, it is clear that the terms are being used to describe the effectiveness of antiretroviral agents as defined by the viral load, not by subsequent actions, such as treatment modification. See '730 patent, Claim 9 (“A method of evaluating the effectiveness of anti-HIV therapy of a patient ... in which an HIV RNA copy number greater than about 500 per 200 ul of plasma correlates positively with the conclusion that the antiretroviral agent is therapeutically ineffective.”). Treatment modification may or may not occur depending upon the methods described in the patents, but neither treatment modification nor non-modification based upon the results of the presence or absence of HIV-encoding nucleic acid are taught by the patents. The methods described serve as one factor, albeit an important one, to consider when the physician is evaluating which anti-retroviral therapy to prescribe. The patents help determine the efficacy of anti-retroviral agents and do not dictate a course of action for the attending physician, if any. Id.
Finally, as discussed above, the patent’s suggestion that the physician may alter treatment is but one embodiment of the innovation and the court refuses to limit the patent’s scope to that one embodiment.
In sum, the court holds that no construction is necessary for “therapeutically effective” and “therapeutically ineffective.”
B. “An antiretroviral agent” 3
Roche argues that “an antiretrovi-ral agent” should be defined as “antiretro-viral agents available to doctors for the treatment of AIDS/HIV infected patients in 1992.” This construction is based on two arguments: 1) the specification defines the term to be those antiretroviral agents “known” at the time; and 2) that the terms must be given their meaning as of the time of the invention. Each argument is discussed below, followed by the three independent and fatal flaws that mar Roche’s construction.
Roche argues that the statement: “An-tiretroviral agent, as used herein, includes any known antiretroviral agent including, but not limited to, dideoxynucleosides” limits the patent only to agents known at the time of the patent. '730 patent at 8:39-41. The plain meaning of the phrase, however, is the opposite. The statement is inclusive and seeks to include, without limiting the scope, agents known at the time. The
*980
specific inclusion of known agents presupposes the existence of agents unknown at the time that may also be considered to be antiretroviral agents.
See Amgen,
Roche relies on
Phillips v. AWH Corp.,
The term “antiretroviral agents” describes a category of pharmaceuticals. This is clear because Roche itself uses the term antiretroviral agents to describe new drug therapies that were unveiled in 1995. Opp. Br. at 8. In May 1992, when Stanford applied for the patents in question, those antiretroviral agents that had been developed were of the type that inhibited reverse transcription. After 1995, this category expanded to include protease inhibitors. For instance, Highly Active An-tiretroviral Therapy (“HAART”) combination therapy was not available until 1995-96. However, this new type of antiretro-viral therapy was anticipated. Articles published in 1990 and 1991 discussed protease inhibitors, indicating they were known. It just took three or four years for their development and availability.
Roche’s reliance on Phillips misses the mark because the temporal context espoused by Phillips is the meaning of the term to a person of ordinary skill at the time of the invention. The term in question may be a category, the contents of which expand over time. It is clear that the term “antiretroviral agents” describes a category of pharmaceuticals because Roche itself uses the term antiretroviral agents to describe new drug therapies that were unveiled in 1995. Opp. Br. at 8. It is clear from the publication history and the prolific research being conducted by HIV researchers on protease inhibitors, that a person of ordinary skill in the art would have known that the category of “antire-troviral agents” would only expand over time to include these new agents.
SuperGuide Corp. v. DirecTV Enterprises, Inc.,
The
SuperGuide
opinion focuses only on the knowledge of one skilled in the art. Specifically, “[i]t appears indisputable that it was known to those skilled in the art during the pendency of the '578 patent application that video data could be communicated in either analog or digital format. Although analog may have been the dominant format of video data when the '578 patent application was filed, we have little doubt that those skilled in the art knew of the existence of digital video data at the time.”
Id.
at 879. In addition, the court stated that it found “no reason here to limit the scope of the claimed invention to analog technology, when ‘regularly received television signals,’ i.e., video data, is broad enough to encompass both formats and those skilled in the art knew both formats could be used for video.”
Id.
at 880. The situation here is indistinguishable. Although agents that inhibit reverse transcription may have dominated the category of antiretroviral agents in May 1992, the court has no doubt that those skilled in the art anticipated antiretroviral agents that were protease inhibitors and other inhibitors yet to be developed.
See
Bartlett Dec., Exh. B. The conceptual work for identifying, antiretroviral agents other than those that had been federally approved had begun as of May 1992.
See id.
Thus, even if they were not available, these after-developed technologies were certainly known in May 1992.
See
Rhyu Supp. Dec., Exh. 27 at 28:5-24 (persons of skill in 1992 knew the steps of the HIV replication cycle and that inhibiting any of the steps could inhibit replication of HIV). Furthermore, the law “does not require that an applicant describe in his specification every conceivable and possible future embodiment of his invention.”
SRI,
This case is distinguishable from
Sobering Corp. v. Amgen Inc.,
Turning from the principles of claim construction that govern the temporal issues to Roche’s construction, the court notes that first of all, it is self-referential. The purpose of claim construction is to resolve disputed meanings and technical scope in order to aid the fact-finder.
See United States Surgical Corp. v. Ethicon, Inc.,
Second, Roche seems to have admitted what the definition of “an antiretroviral agent” ought to be, even though it proposes that the court adopt a different construction. Roche states that “[ajntiretrovi-ral agents are drugs that are effective in reducing or stopping replication of retroviruses.” Opp. Br. at 2, 22; Bartlett Dec., ¶¶ 38^11. Roche’s clear and succinct definition of “an antiretroviral agent” undercuts all of their other arguments regarding any alternate construction. Furthermore, this construction is very close to Stanford’s proposed construction.
Third, Roche seeks to include three limitations that are not present in the term. Specifically, Roche seeks to limit the scope of antiretroviral agents to: 1) those available to doctors; 2) those available for the treatment of AIDS/HIV infected patients; and 3) those available in 1992. Each of these limitations fails for the same reasons described above regarding after-developed technologies — they all attempt to limit the scope of “antiretroviral agents” when there is no evidence that the patentee intended the same.
Stanford, in turn, argues that “an antire-troviral agent” should be construed as “at least one substance having or capable of having an effect against a retrovirus, such as HIV.” This effect may be either positive or negative. Roche does not argue that the construction may include more than one substance as its own definition construes the term in the plural. The plain language of the term is not limited to monotherapy. Indeed, the patents in suit specifically refer to combination therapy. '730 patent at 7:63-8:14; 9:46-48; 13:9-11. This demonstrates that the inventors and those of ordinary skill in the art were aware of combination therapy.
The rest of Stanford’s construction describes antiretroviral agents using generally accepted dictionary definitions. The construction closely matches the definition given by Roche, that “[a]ntiretroviral agents are drugs that are effective in reducing or stopping replication of retroviruses.” Opp. Br. at 2; id. at 22; Bartlett Dec., ¶¶ 38-41. Roche’s construction requires that the agent be effective in reducing or stopping replication of retroviruses. The same, however, goes against the patent construed as a whole. The patent is designed to measure the effectiveness of antiretroviral agents and therefore the construction must include the fact that the agent may or may not be effective in re *983 ducing or stopping replication of the retrovirus. Thus, Stanford’s construction is superior because it allows for the possibility that the agent may not in fact be effective against the retrovirus. The court therefore adopts the following construction for “an antiretroviral agent”: “at least one substance having or capable of having an effect against a retrovirus, such as HIV.”
C. “Measuring the HIV RNA copy number”
Roche seeks to define this term as “techniques available in May 1992 to quantify HIV RNA copy number using PCR, specifically the assay in the 1991 JID article as set forth in the specifications.” Stanford, on the other hand, argues that no construction is necessary because the plain meaning suffices to guide the jury in its fact-finding.
Roche argues that Stanford’s patents enable no more than the five-step end point PCR assay set forth in the 1991 JID paper and that “[t]he scope of the claims must be less than or equal to the scope of the enablement.”
Nat’l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc.,
Roche also seeks to limit the measuring steps used to determine the HIV RNA copy number to the techniques available in May 1992 because after-developed technologies such as real-time PCR and internal standards were not taught by the patents and unknown when Stanford applied for the patents. Specifically, Roche claims that what one of skill in the art today would understand by a method using PCR is different than it would have been in May 1992. That argument is not related to the definition of “measuring the HIV RNA copy number” because the copy number is measured using the
product
of the PCR. Roche is again confusing claim construction issues with infringement issues. Roche may well argue, at the summary judgment stage or later, that its product does not infringe upon Stanford’s patents based upon the claim limitations, but it may not inject the end point PCR limitation into the definition of “measuring the HIV RNA copy number.” It is settled patent law that the claims of a patent must not be construed as being limited to the embodiment if the patent describes only one embodiment.
Phillips,
Nevertheless, the claims that state “about 30 cycles” must be limited to endpoint PCR. The court can, as part of claim construction, construe the scope of “about 30 cycles.” The claims’ specific reference to the number of cycles of PCR must limit those claims to end-point PCR as a specific number of cycles is only germane within the context of end-point PCR. The fact that the number of cycles is irrelevant in real-time PCR further buttresses this finding.
*984
Some of the patent claims, however, do not limit themselves to “80 cycles of PCR,” but use the more generic term “PCR.”
See
'041 patent, Claims 1-3, 5-8. This categorical term is distinguishable from the categorical anti-retroviral agents because there is no evidence in the record that, as of 1992, one of ordinary skill in the art knew of real-time PCR or of its conceptual framework. Thus, based on
SuperGuide,
the term “PCR” cannot include real-time PCR.
Mass. Inst of Tech. v. Abacus Software,
In sum, the court holds that no construction is necessary for “measuring the HIV RNA copy number,” but limits the claims stating “about 30 cycles” to end-point PCR and excludes real-time PCR from the scope of the term “PCR.”
D. “Presence of detectable HTV-encoding nucleic acid” and “absence of detectable HTV-encoding nucleic acid”
Roche argues that these terms be construed as a “qualitative result indicating greater than or less than 40 copies of HIV RNA per 200 ul of sample.” Stanford argues that no construction in necessary because the plain meaning is sufficient to guide the jury’s fact finding. Roche seeks to construe this term as a qualitative yes or no test based upon the lowest detection level taught by the patent, 40 copies per 200 micro-liters of sample, because these terms are in direct contrast to the claims that include a specific measuring step. Roche again attempts to interject a specific copy number limitation into the construction. This attempt fails for the same reasons as above, where a construction including a temporal limitation or particular assay limitation was rejected. The plain and ordinary meaning of “detectable” has to be an amount of substance that is higher than the lowest level of sensitivity of whatever assay is actually used in practicing the claimed methods. Furthermore, the patent demonstrates that the patentee inserted specific numerical limitations when desired. See '730 patent, Claim 9. The court refuses to integrate numerical limitations into the construction where none was contemplated by the patentee.
Roche argues that different terms in different claims must have different meaning and that Stanford’s construction reduces “presence” and “absence” to “measuring.” Roche is correct in its contention that a difference in meaning is presumed.
Nystrom v. TREX Co.,
In addition, there is no basis for Roche’s claim that the detection process be a quali
*985
tative process. In fact, there is evidence to the contrary — that a quantitative process was envisioned.
See, e.g.,
'730 patent at 5:53-57, 10:34-40,12:58-60. This is further buttressed by Stanford’s statements made while prosecuting the patents, which distinguish an article by Ottoman based on the fact that the article described using non-quantitative PCR assays.
See
Rhyu Dec., Exh. 25 at STAN 1435, 1458. This evidence may be relied upon in spite of
Honeywell Int’l v. ITT Indus., Inc.,
A quantitative process is necessary because a minimum amount of the compound must be present for any detection method to test for the presence or absence of the compound. Thus testing for the “presence” or “absence” is really the same as “measuring,” except that if the measurement reveals any amount greater than zero (or the minimum amount necessary to be detectable), the actual amount of the compound is irrelevant.
Stanford’s neglect in failing to define the terms is of no import and consequently the terms will not be construed against Stanford. Though the patentee may choose to be his own lexicographer, he does not have to be. In general, the claim terms will carry their ordinary and customary meaning and this court will not import limitations from the specifications into the claims unless it is clear from the specifications that the same was intended.
Finally, for reasons described above, Roche’s enablement arguments are just as misplaced here as they were with respect to the other claim terms.
In sum, the court holds that no construction is necessary for “presence of detectable HIV-eneoding nucleic acid” and “absence of detectable HIV-encoding nucleic acid.”
CONCLUSION
For the foregoing reasons, the court construes the disputed claims in the manner described above.
Notes
. Roche Diagnostic Systems, Inc. was dismissed as a defendant without prejudice by stipulation of the parties entered on November 17, 2005.
. Roche has agreed to Stanford's proposed definitions of "collecting statistically significant data useful for determining whether a decline in HIV RNA copy numbers exists,” "statistically significant data,” and "statistically significant decline."
. The definition of “anti-HIV agent,” consistent with "anti-retroviral agent,” is thus “at least one substance having or capable of having an effect against HIV.”