Citations
- 712 F. Supp. 2d 885
Full opinion text
ORDER
JOAN N. ERICKSEN, District Judge.
American Medical Systems, Inc., and its subsidiary, Laserscope, (collectively, AMS) assert claims of patent infringement against Laser Peripherals, LLC (LP). LP counterclaims for declarations of noninfringement, invalidity, and unenforceability. The case is before the Court on cross-motions for summary judgment, motions to exclude expert testimony, and LP’s motion to strike certain materials filed by AMS in support of its motion for summary judgment. The Court grants in part and denies in part the summary judgment motions, and resolves the motions to exclude and to strike as set forth below. The Court sets this case for trial beginning Monday, July 12, 2010.
I. BACKGROUND
AMS owns U.S. Patent No. 5,428,699 (filed July 2, 1993), which is entitled “Probe Having Optical Fiber for Laterally Directing Laser Beam.” Dr. Russell Pon is the sole named inventor on the '699 Patent. According to the '699 Patent, the probe can be used to treat benign prostatic hyperplasia, which causes an enlarged prostate. The probe laterally directs laser energy out of a tip of a waveguide, such as an optical fiber, onto selected portions of the enlarged prostate to cause necrosis of the tissue. The necrotic tissue sloughs off as small particles which are passed away during urination. The claims of the '699 Patent are directed to apparatuses for communicating and laterally directing electromagnetic energy and probes for treating benign prostatic hyperplasia.
AMS contends that LP infringes independent claims 1 and 25, as well as dependent claims 27-30, of the '699 Patent. The Court construed the disputed claim terms in an Order dated October 13, 2009, 665 F.Supp.2d 1025 (D.Minn.2009). Claim 1 recites:
An apparatus for communicating and laterally directing electromagnetic radiation, comprising:
a waveguide having a tip for communicating electromagnetic radiation in a propagation direction to the tip of the waveguide;
a transmitting surface on the tip of the waveguide;
a reflecting surface on the tip of the waveguide for internally reflecting electromagnetic radiation communicated by the waveguide in a direction lateral to the propagation direction toward a particular area on the transmitting surface; and
wherein the particular area and the reflecting surface are disposed so that greater than about 90% of electromagnetic radiation reflected by the reflecting surface is incident on the particular area at below a critical angle for transmission through the transmitting surface in the lateral direction.
Claim 25 recites:
A surgical probe for treating benign prostatic hyperplasia (BPH), said probe, comprising:
a waveguide having a tip with a glass cladding extending to a distal end of the tip, the waveguide for communicating electromagnetic radiation in a first propagation direction to the tip of the waveguide; means for positioning the waveguide during surgery;
a transmitting surface on the tip of the waveguide;
a reflecting surface on the tip of the waveguide for internally reflecting electromagnetic radiation communicated in the first propagation direction by the waveguide in a second propagation direction toward the transmitting surface; and
wherein at least 90% of all electromagnetic radiation reflected by the reflecting surface is incident on the transmitting surface at below a critical angle for transmission through the transmitting surface.
According to the '699 Patent, a significant portion of the electromagnetic radiation in prior art probes did not leave the optical fiber in the desired direction due to internal reflection of the laser beam off interfaces between the optical fiber and surrounding environment. Prior art probes used reflective and anti-reflective coating layers to reduce misdirected laser energy, but those layers could melt or carbonize if used at high temperatures, thereby decreasing the efficiency of the probes. The claimed invention improves the efficiency of laterally-directing (side-firing) probes by reducing internal reflection off the surface through which the laser beam is transmitted.
AMS contends that LP’s “SeatterFree Lateral Emitting Laser Fibers” infringe the '699 Patent. AMS accuses the following SeatterFree devices: the DBLF-60SF, the HBLF-60SF, the LISA HBLF-60SF, the DBLF-SF-MM, the OBM001239, and the HBLF-60SF-PL. The following figure' from U.S. Patent No. 5,537,499 (filed Aug. 18, 1994) illustrates the distal end of the accused devices.
According to the '499 Patent, the accused devices include an optical fiber 117 having a silica fiber core surrounded by a cladding 119. The cladding 119 maintains light within the optical fiber 117. The cladding in the accused devices is a fluorine-doped silica cladding. The optical fiber 117 terminates in a bevelled surface 118. A silica capsule or cap 122 encloses the distal end of the optical fiber 117 and maintains the distal end of the optical fiber 117 within an air chamber 124. During manufacture of the accused devices, a laser beam fuses the distal end of the optical fiber 117 to the inside wall of the silica capsule 122 at the fused window 125. During use, a laser beam 130 propagates down the optical fiber 117 and is redirected by the bevelled surface 118 laterally through the distal end of the optical fiber 117, the fused window 125, and the capsule 122.
II. DISCUSSION
A. Motions to exclude expert testimony and to strike
LP moves to exclude the expert testimony of Dr. Thomas Milster under Rule 702 of the Federal Rules of Evidence and to strike certain materials filed by AMS in support of its motion for summary judgment for failure to comply with Rules 26(a) and 56(e) of the Federal Rules of Civil Procedure. AMS moves to exclude the expert testimony of Dr. Wayne Knox and George Gerstman under Rule 702.
1. Legal standards
Rule 702 provides:
If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.
When evaluating the admissibility of expert testimony, a trial court serves as the “gatekeeper” that ensures the reliability and relevance of the expert testimony offered into evidence. Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 149, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999). The proponent of the proposed expert testimony must demonstrate its admissibility by a preponderance of the evidence. Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686 (8th Cir.2001). Proposed expert testimony must meet three prerequisites to be admitted under Rule 702. Id. First, evidence based on scientific, technical, or other specialized knowledge must be useful to the finder of fact in deciding the ultimate issue of fact. Id. Second, the proposed expert witness must be qualified to assist the finder of fact. Id. Third, the proposed testimony must be reliable or trustworthy in an evidentiary sense. Id. To satisfy the third requirement, the proposed testimony must be based on sufficient facts or data, the proposed testimony must be the product of reliable principles and methods, and the proposed expert witness must have applied the principles and methods reliably to the facts of the case. Id.
Rule 26(a) requires a party to disclose the identity of any expert witness it intends to use at trial and provide with that disclosure a written report prepared and signed by the witness, including a complete statement of all opinions the witness will express and the basis and reasons for them, “at the times and in the sequence” ordered by a court. Fed.R.Civ.R. 26(a)(2)(A)-(C). A party that fails to disclose information required by Rule 26(a) shall not be permitted to use that information as evidence at a trial, at a hearing, or on a motion unless the failure is harmless or substantially justified. Fed.R.Civ.P. 37(c)(1); see Trost v. Trek Bicycle Corp., 162 F.3d 1004, 1008 (8th Cir.1998). When fashioning a remedy for untimely disclosure, a court should consider the reason for noncompliance, the surprise and prejudice to the opposing party, the extent to which allowing the information or testimony would disrupt the order and efficiency of the trial, and the importance of the information or testimony. Wegener v. Johnson, 527 F.3d 687, 692 (8th Cir.2008).
Finally, “[t]o be considered on summary judgment, documents must be authenticated by and attached to an affidavit made on personal knowledge setting forth such facts as would be admissible in evidence or a deposition that meets the requirements of Fed.R.Civ.P. 56(e).” Stuart v. Gen. Motors Corp., 217 F.3d 621, 635 n. 20 (8th Cir.2000). Documents that fail to meet those requirements cannot be considered. Id.
2. Dr. Thomas Milster
a. Transmission experiments
Milster, a professor of optical sciences, electrical engineering, and computer engineering at the University of Arizona, conducted three experiments intended to measure light transmitted from the accused devices in a desired lateral direction (PI) and in the opposite direction (P2). The purpose of those experiments was to determine whether the accused devices met the claim limitations “wherein the particular area and the reflecting surface are disposed so that greater than about 90% of electromagnetic radiation reflected by the reflecting surface is incident on the particular area at below a critical angle for transmission through the transmitting surface in the lateral direction” and “wherein at least 90% of all electromagnetic radiation reflected by the reflecting surface is incident on the transmitting surface at below a critical angle for transmission through the transmitting surface” (collectively, 90% limitations).
LP first contends that Milster’s experiments are irrelevant because they relate to transmission, not incidence, and the claims require the light to be “incident on the [transmitting surface/particular area] at below a critical angle for transmission through the [transmitting surface/particular area].” LP argues that the incident light does not equal the light transmitted through the particular area/transmitting surface and that Milster should have measured the critical angle, the amount of light reflected off the reflecting surface, and the light incident on the transmitting surface/particular area at below the critical angle.
“A patentee may prove infringement by any method of analysis that is probative of the fact of infringement, and circumstantial evidence may be sufficient.” Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1372 (Fed.Cir.2009) (quotation marks and citation omitted). Here, Milster measured light in the PI direction and light in the P2 direction using a flat optical power meter and calculated a transmission “ratio” of PI / (PI + P2). This measurement and calculation correspond to a test described in the '699 Patent. Where, as here, the claims do not specify any particular form of testing, a patentee may use a test “expressly approved by the patent specification” to prove infringement. See Union Carbide Chems. & Plastics Tech. Corp. v. Shell Oil, 425 F.3d 1366, 1375 (Fed.Cir.2005). Although LP seeks to limit the transmission test described in the '699 Patent to embodiments having a certain core-to-core-cladding ratio because the specification described testing such an embodiment, nothing in the language of the '699 Patent suggests the described transmission test is so limited.
Moreover, while the claims include limitations directed to the ratio of the light reflected by the reflecting surface and light incident on the transmitting surface/particular area at below the critical angle, they do not require any specific critical angle, amount of light reflected by the reflecting surface, or amount of light incident on the transmitting surface/particular area at below the critical angle, nor do they impose any limitation on the size of the transmitting surface/particular area. Consequently, LP’s argument that Milster’s experiments are irrelevant because he did not measure those characteristics is unpersuasive. Cf. Bai v. L & L Wings, Inc., 160 F.3d 1350, 1353 (Fed.Cir.1998) (explaining that second step in infringement analysis is comparing properly construed claims to accused device). LP also contends that Milster’s experiments are irrelevant because he did not conduct them in water. For the reasons stated below with respect to AMS’s motion to exclude Knox’s testimony, the Court rejects this argument.
Next, LP contends that Milster should have used ray tracing, which is also described in the '699 Patent, to measure the light activity within the optical fiber. LP cites no authority indicating that a patentee is required to perform every test described in the patent to prove infringement. Moreover, LP did not submit the results of any ray tracing or any other evidence indicating that the results of ray tracing would call into question the relevance of Milster’s experiments. Milster’s failure to perform any ray tracing does not provide a basis for excluding his opinions about his transmission experiments. The Court denies LP’s motion to exclude as irrelevant Milster’s testimony about his transmission experiments.
LP also contends that Milster’s experiments are unreliable because (1) he did not account for certain losses within the waveguide, (2) he overcaptured light in the PI direction and undercaptured light in the P2 direction, and (3) he estimated rather than calculated the coupling losses between the laser source’s output and the light introduced into the fiber. Because LP provides no evidence of the effect any of those alleged flaws would have on Milster’s measurements, LP’s concerns go to the weight of Milster’s testimony rather than its admissibility. See Liquid Dynamics Corp. v. Vaughan Co., 449 F.3d 1209, 1221 (Fed.Cir.2006) (testimony about results of computer models was admissible even though models did not exactly match the accused products). Moreover, Jeffrey Stein, a vice-president of LP, testified that LP measures light emitted from the accused devices using a flat optical power meter as part of its quality testing. LP’s use of a transmission test similar to Milster’s indicates that such transmission tests are generally accepted in the field, and therefore are reliable. See Peitzmeier v. Hennessy Indus., Inc., 97 F.3d 293, 298 (8th Cir.1996). The Court denies LP’s motion to exclude as unreliable Milster’s testimony about his transmission experiments.
b. SEM-EDS results
Milster opines, based on his review of the results of tests performed using energy-dispersive x-ray spectroscopy coupled with a scanning electron microscope (SEM-EDS), that fluorine remains in the fused window of the accused devices after the capsule is fused to the fiber. Relying on Dura Automotive Systems of Indiana, Inc. v. CTS Corp., 285 F.3d 609 (7th Cir.2002), LP argues that Milster’s opinions regarding the presence of fluorine should be excluded because the operator of the SEM-EDS designed and conducted the test.
An expert witness may rely on facts or data not based on personal perception if the facts or data are “of a type reasonably relied upon by experts in the particular field in forming opinions or inferences upon the subject.” Fed.R.Evid. 703; see Monsanto Co. v. David, 516 F.3d 1009, 1015-16 (Fed.Cir.2008) (affirming admission of expert testimony where expert relied on “scientific reports prepared by his team”); Ratliff v. Schiber Truck Co., 150 F.3d 949, 955 (8th Cir.1998) (permitting accident reconstructionist to rely on police officer’s report because it was “of the type reasonably relied upon by accident reconstructionists in forming their opinions”). “[I]t is common in technical fields for an expert to base an opinion in part on what a different expert believes on the basis of expert knowledge not possessed by the first expert; and it is apparent from the wording of Rule 703 that there is no general requirement that the other expert testify as well.” Dura, 285 F.3d at 613.
In Dura, the excluded expert testimony relied on computer models of groundwater flow created by assistants where the models were “inherently not the most precise of scientific tools” because “one never possesses complete geotechnical information.” Id. at 614. The court of appeals affirmed the exclusion in part because the creation of such models required the use of professional discretion and “groundwater modeling is not the sort of thing that a lab technician or other subprofessional does.” Id. Here, Milster prepared the samples and was present while a lab technician performed the tests. According to Milster’s deposition testimony, the amount of discretion exercised by the lab technician amounted to adjusting the height and rotation of the sample to look at a specific area of interest and adjusting the focus and astigmatism to obtain a clear image. LP provides no evidence indicating that an SEM-EDS is an imprecise tool, that lab technicians do not typically perform SEM-EDS testing, or that the lab technician exercised more than a minimal amount of discretion or performed anything other than routine procedures in conducting the tests. Moreover, LP does not assert that Milster does not know how to interpret SEM-EDS results or that scientists such as Milster do not regularly rely on such testing. In fact, Milster’s deposition testimony demonstrates his familiarity with interpreting such test results. Dura is distinguishable, and the Court denies LP’s motion to exclude Milster’s opinions about the SEM-EDS results.
c. Motion to strike
LP also moves to strike additional portions of Milster’s reports and a declaration filed by Milster on March 28, 2010. First, LP contends that the results of Milster’s transmission experiments should be stricken because their results were not disclosed in AMS’s claim chart and “directly contradict” AMS’s claim chart. AMS asserted in its claim chart that “testing performed on defendant’s ScatterFree Laser Fibers showed that greater than about 90% of the electromagnetic radiation introduced in defendant’s fiber product is transmitted in the lateral direction from the device.” LP moved to compel production of that testing, and the magistrate judge denied the motion except to the extent LP sought evidence not protected by the work-product doctrine. AMS did not produce the test results, and LP did not appeal the magistrate judge’s order.
LP now argues that AMS cannot rely on Milster’s experiments because AMS did not produce its pre-litigation test results. LP first asserts that Milster performed the testing referenced in AMS’s claim chart. No evidence supports this assertion; rather, Milster testified that all of his experimental results were disclosed with his expert reports and that the only testing he was aware of was his own. LP also asserts that the experimental results disclosed in Milster’s expert report should have been disclosed in AMS’s claim chart. Given that AMS’s claim chart was due in March 2009 and initial expert reports were not due until January 2010, such a requirement would make no sense. LP cites no authority for imposing such a requirement, and the Court declines to do so here.
LP’s second argument that Milster’s experimental results “directly contradict” the infringement contentions in AMS’s claim chart is without merit. Milster stated in his infringement expert report: “[0]f the energy that I attempted to have input into the SeatterFree device, approximately 83-87% was detected in the desired (targeted) lateral direction.... This corresponds to 96-98% of the reflected electromagnetic radiation being detected in the targeted lateral direction.” Milster then explains that, typically, up to 10% of the energy input into a waveguide is lost due to coupling between the laser source and the waveguide and that an additional 4% is lost due to Fresnel reflections. LP may question the accuracy of Milster’s conclusions, but Milster’s results themselves do not contradict AMS’s infringement contentions. Moreover, LP’s surprise that Milster calculated the ratio as PI / (PI + P2) rather than PI / (laser source output) is puzzling given that the denominator of the ratio in the test described in the '699 Patent was not the laser source’s output. See '699 Patent col. 12 11. 6-11 (calculating ratio as 80 / (80 + 5) and concluding “of the 85% of the input energy which was detected on transmission out of the fiber, greater than 90% (about 94%) of the energy was transmitted ... without undesirable deflection”). The Court denies LP’s motion to strike the results of Milster’s transmission experiments.
LP next argues that Milster’s expert reports contain multiple statements that lack foundation and are hearsay because they relate to medical analysis of prostate glands and benign prostatic hyperplasia, to Laserscope’s sales of various devices, to what LP tells its customers, to how LP’s customers use the accused devices, and to how endoscopes are used during surgery. LP identifies as inadmissible over seventy paragraphs in Milster’s infringement report and over one hundred paragraphs in Milster’s invalidity report, many of which have nothing to do with the asserted grounds for exclusion. In light of LP’s failure to properly identify the paragraphs containing the challenged subject matter, the Court denies LP’s motion to strike without prejudice to LP’s ability to bring a motion in limine on this issue.
Finally, LP argues that Milster’s expert reports must be stricken for failure to comply with Rule 56(e). AMS did not include a declaration or affidavit of Milster swearing to the truth of the matters contained within his expert reports when it filed its motion for summary judgment. See Rainforest Cafe, Inc. v. Amazon, Inc., 86 F.Supp.2d 886, 904 (D.Minn.1999). On March 28, 2010, AMS filed Milster’s declaration affirming the truth of the matters contained within his reports. Consequently, AMS has “cured” its initial failure to authenticate Milster’s expert reports. See DG & G, Inc. v. FlexSol Packaging Corp. of Pompano Beach, 576 F.3d 820, 825-27 (8th Cir.2009). The Court denies LP’s motion to strike Milster’s expert reports for failure to comply with Rule 56(e).
3. Dr. Wayne Knox
a. Transmission testing
Knox, a professor of optics and the director of the Institute of Optics at the University of Rochester, opines that whether a device meets the 90% limitations could not be determined using the transmission test described in the '699 Patent because the test does not measure light activity within the waveguide. Knox also stated that he “was not able to think of how to do an experiment that will determine whether any device meets all the limitations of [the claims].” AMS moves to exclude those opinions. For the reasons stated with respect to LP’s motion to exclude Milster’s testimony, the transmission experiments performed by Milster are relevant to the question of whether the accused devices meet the 90% limitations. To permit Knox to testify that whether the 90% limitations are met cannot be determined would not assist the jury in ascertaining whether the accused products meet those limitations. Consequently, the Court excludes Knox’s opinions that no experiment can determine whether the 90% limitations are met and that Milster’s transmission experiments “measure[d] the wrong thing” because they did not measure light activity within the waveguide.
AMS also moves to exclude Knox’s opinion that Milster’s transmission experiments were flawed and the claims are indefinite under 35 U.S.C. § 112, ¶ 2 (2006), because the experimental results will vary depending on whether the test is conducted in air or water. A claim is definite “if a person skilled in the field of the invention would reasonably understand the claim when read in the context of the specification.” Marley Mouldings Ltd. v. Mikron Indus., Inc., 417 F.3d 1356, 1360 (Fed.Cir.2005). The '699 Patent describes how to determine an appropriate core-to-core-cladding ratio based on the refractive index of the core cladding and the refractive index of air and then explains “[t]his embodiment ... achieves substantially improved performance” of the probe, as shown by the subsequently-described “comparative experimental results.” '699 Patent col. 11 1. 9-col. 12 1. 41. Although Knox opines that the described experiment could have been conducted in water if the optical power meter were placed in a plastic bag, he conceded during his deposition that the description of the experiment makes no mention of a plastic bag or any other equipment that would permit it to be conducted in water. Moreover, Pon testified that optical engineers do not conduct tests using optical power meters in water. In short, a person of ordinary skill in the art would understand that the transmission test described in the '699 Patent was conducted in air and that the appropriate medium for transmission testing is air. The Court excludes Knox’s opinions that Milster’s transmission testing is irrelevant or was otherwise inappropriate because it was conducted in air and that a person of ordinary skill in the art would not know whether to conduct transmission testing in air or water.because such testimony would not assist the jury in determining a fact at issue or understand the evidence.
Knox also opines that Milster’s transmission experiments were flawed and that the claims are indefinite because the results of transmission testing depend on factors including the launch conditions of the laser and the light’s polarization and wavelength. He further opines that Milster may have overcaptured light in the PI direction and undercaptured light in the P2 direction. AMS seeks exclusion of those opinions because Knox did not quantify the effect of those factors and their effect is minimal when testing the accused devices. Even if the effect of those factors is minimal when testing the accused devices, whether a claim meets the requirements of § 112 is measured by the scope of the claimed invention, not the scope of the accused devices. See LizardTech, Inc. v. Earth Res. Mapping, Lie., 424 F.3d 1336, 1344-45 (Fed.Cir.2005). AMS’s concerns about the significance of those factors go to the weight of Knox’s testimony, not its admissibility. See Liquid Dynamics, 449 F.3d at 1221. The Court denies AMS’s motion to exclude Knox’s opinions about the effect of those factors on Milster’s transmission experiments or indefiniteness.
b. § 112
AMS also seeks exclusion of Knox’s opinions that the terms “transmitting surface,” “particular area” and the 90% limitations fail to meet the definiteness, written description, and enablement requirements of § 112 because they are based on the wrong legal standards. LP responds that Knox stated the correct legal standards in his expert report. As previously stated, a claim is definite if a person skilled in the art would reasonably understand the claim when read in light of the specification. Marley Mouldings, 417 F.3d at 1360. Claims are enabled if a person of ordinary skill in the art could make and use the full scope of the invention without undue experimentation. LizardTech, 424 F.3d at 1345. The written description requirement mandates that the specification describe the invention sufficiently to convey to a person of ordinary skill in the art that the patentee had possession of the claimed invention at the time of the application. Id.
Despite correctly stating those legal standards in his expert report, Knox failed to properly apply them to the facts of this case. Instead, he concluded that the transmitting surface/partieular area and 90% limitations do not meet the requirements of § 112 because the specification “does not clearly define” the location of or where the transmitting surface/partieular area begins and ends and because there could be more than one transmitting surface/particular area in a device. The asserted claims do not require the transmitting surface/partieular area to have certain dimensions or a precise location, and definiteness does not require specification of the precise location or dimensions of a claim limitation if a person of ordinary skill in the art would understand the claim. See Young v. Lumenis, Inc., 492 F.3d 1336, 1346-47 (Fed.Cir.2007) (reversing district court’s grant of summary judgment that claim term “near” was indefinite).
Moreover, because the Court construed the claims as permitting, but not requiring, more than one transmitting surface/partieular area, it does not matter which transmitting surface/partieular area results in infringement as long as at least one does. See SunTiger, Inc. v. Sci. Research Funding Group, 189 F.3d 1327, 1336-37 (Fed.Cir.1999) (“If a claim reads merely on a part of an accused device, that is enough for infringement.”). Consequently, Knox’s opinions are inadmissible because they are based on incorrect legal standards. See Hebert v. Lisle Corp., 99 F.3d 1109, 1117 (Fed.Cir.1996) (“Incorrect statements of law are no more admissible through ‘experts’ than are falsifiable scientific theories.”). The Court excludes Knox’s opinions that the transmitting surfacq/particular area and the 90% limitations are indefinite because the specification does not include the precise dimensions and location of the transmitting surface/particular area and because a device could have multiple transmitting surfaces/particular areas.
c. Obviousness
AMS moves to exclude Knox’s conclusions about obviousness as conclusory and because he provided no reason to combine the claim elements. LP responds that Knox provided “ample analysis” to support his obviousness opinions.
In the obviousness sections of his invalidity report, Knox described the teachings of certain prior art references and then concluded that “[a] person of ordinary skill would have been motivated to combine the [references]” or that “[b]ased on the field of the invention and the subject matter of these prior art references, a person of ordinary skill in the art would have been motivated to combine [these references].” Although the law does not require an explicit teaching, suggestion, or motivation to combine prior art references, it may be important to identify a reason why a person of ordinary skill in the art would have combined the elements in the manner of the claimed invention. Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357, 1374 (Fed.Cir.2010). Because Knox simply describes the prior art, identifies no reason to combine the references in the manner claimed, and fails to “state how or why a person ordinarily skilled in the art would have found the claims ... obvious in light of some combination of those particular references,” his conclusions as to obviousness “would not [be] helpful to a lay jury in avoiding the pitfalls of hindsight that belie a determination of obviousness.” See Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1373 (Fed.Cir.2008). Knox may not testify as to obviousness under § 103.
d. '312 Patent
AMS moves to exclude Knox’s testimony about anticipation and obviousness insofar as it is based on U.S. Patent No. 5,253,312 (filed June 26, 1992) because LP did not include that patent in its prior art chart. LP responds that Knox will not testify about anticipation and obviousness based on the '312 Patent, but that he may testify about the '312 Patent in the context of §112 or prosecution history estoppel. Knox did not base any of his conclusions regarding § 112 on the '312 Patent, and he did not opine at all on prosecution history estoppel. LP provides no explanation for his failure to do so, and given that fact and expert discovery have closed, the Court concludes that AMS would be harmed if required to respond to expert opinions not yet disclosed. See Fed.R.Civ.P. 26(a)(2)(B), 37(e)(1). Consequently, the Court excludes Knox’s opinions regarding the '312 Patent in the context of anticipation, obviousness, § 112, or prosecution history estoppel.
4. Jeff Gang Lei
On March 28, 2010, AMS submitted the declaration of Dr. Jeff Gang Lei in opposition to LP’s motions for summary judgment. Lei is a senior optical engineer with experience using ray-tracing software to model side-firing optical fibers used in medical devices. Lei states that he modeled devices having characteristics similar to the accused devices and that his modeling indicates that the modeled devices met the 90% limitations. LP moves to strike Lei’s declaration because AMS did not disclose Lei as an expert witness in accordance with the pretrial schedule. AMS responds that Lei’s declaration complies with Rule 26(a)(2)(C)(ii) because it “is intended solely to contradict or rebut evidence on the same subject matter identified by another party under Rule 26(a)(2)(B), within 30 days after the other party’s disclosure,” and with Rule 37 because the late disclosure was substantially justified by Knox’s late disclosure of his ray-tracing opinions.
In a declaration filed on March 12, 2010, Knox stated that ray tracing could be used to determine if the 90% limitations are met and criticized Milster for not performing ray tracing. LP asserts that Knox previously disclosed his ray-tracing theory on page 12 of his expert report on noninfringement. The identified paragraph in Knox’s expert report describes taking a series of measurements. It does not suggest that ray tracing could be used to determine if the 90% limitations are met. Moreover, Knox stated at least twice in the same expert report that he could not think of any way to determine if any device meets the claim limitations. The Court concludes that Knox’s expert reports did not disclose the opinion that ray tracing could be used to determine if the 90% limitations are met. LP also contends that Knox disclosed his ray-tracing opinions during his deposition on March 2, 2010. Regardless of whether Knox first disclosed his ray-tracing opinions during his March 2 deposition or in his March 12 declaration, Lei’s opinions, disclosed on March 28, wei-e still disclosed within the 30-day window of Rule 26(a)(2)(C)(ii). Further, the disclosure of Lei’s opinion after the deadline for expert reports is substantially justified given the timing of Knox’s declaration and the contradiction between it and his earlier statements about the impossibility of determining whether the 90% limitations are met. The Court denies LP’s motion to strike Lei’s declaration under Rules 26(a) and 37(c).
LP also contends that Lei’s declaration is unreliable because he made assumptions when conducting the analysis. Criticisms of Lei’s assumptions go to the weight given his conclusions, not their admissibility. See Liquid Dynamics, 449 F.3d at 1221. The Court denies LP’s motion to strike Lei’s declaration.
5. Deposition testimony from an unrelated case
AMS used testimony from depositions taken in an unrelated case involving the '699 Patent in support of its motion for summary judgment. Relying on Kirk v. Raymark Industries, Inc., 61 F.3d 147 (3d Cir.1995), LP moves to strike the deposition testimony as hearsay. In Kirk, the court of appeals found that the district court abused its discretion by admitting the prior testimony of an out-of-court witness at trial. 61 F.3d at 162-64. In the summary judgment context, a deposition “is at least as good as an affidavit” and may be used whenever an affidavit would be permissible, even if the conditions of the rule on use of a deposition at trial are not satisfied. Diamonds Plus, Inc. v. Kolber, 960 F.2d 765, 767-68 (8th Cir.1992). The Court denies LP’s motion to strike the deposition testimony from the unrelated case.
6. George Gerstman
LP submitted the expert report of George Gerstman, a former patent examiner and practicing patent attorney, in support of its inequitable conduct arguments. AMS moves to exclude Gerstman’s testimony as unhelpful because it is speculative and merely tells the Court what conclusion to reach regarding inequitable conduct. LP responds that Gerstman is qualified and “has been permitted to testify at trial on these types of topics numerous times.”
Inequitable conduct is an equitable defense to patent infringement that is most appropriately reserved for a court. Rothman v. Target Corp., 556 F.3d 1310, 1322 (Fed.Cir.2009). In dealing with the U.S. Patent and Trademark Office (USP-TO), applicants for a patent have a duty of candor and good faith which includes a duty to disclose all information known by them to be material to patentability. 37 C.F.R. § 1.56 (2008). Whether an applicant has complied with the duty of disclosure is relevant to the issue of inequitable conduct. See Digital Control, Inc. v. Charles Mach. Works, 437 F.3d 1309, 1316 (Fed.Cir.2006).
Gerstman opines that Paul Davis, an attorney at Laserscope, breached the duty of disclosure when prosecuting the '699 Patent. Courts routinely exclude such testimony because it simply tells a court what conclusion to reach on the issue of inequitable conduct. See, e.g., Se-Kure Controls, Inc. v. Diam USA Inc., Civil No. 06-4857, 2009 WL 77463, at *2 (N.D.Ill. Jan. 9, 2009) (“As stated above, Mr. Gerstman’s statements that he expects to testify about Se-Kure’s failure to comply with its duty of disclosure, resulting in equitable conduct, is simply inadmissible.... Testimony by a witness ... may not include legal conclusions.”); Anagram Int’l, Inc. v. Mayflower Distrib. Co., Civil No. 07-1142, 2008 WL 5500764, at *1 (D.Minn. Aug. 21, 2008) (“[A]ny testimony from [the expert] regarding his opinions, legal or otherwise, regarding inequitable conduct, including his opinions regarding materiality or the intent to deceive, are presumptively inadmissible.”); Pharmacia Corp. v. Par Pharm., Inc., Civil No. 01-6011, 2004 WL 5614917, at *2 (D.N.J. Feb. 18, 2004) (“[T]he Court will not permit [the expert] to offer testimony regarding alleged inequitable conduct or materiality.”).
Gerstman also states that the patent examiner “has very limited access to non-patent prior art” and “does not leave the Patent Office to search for prior art nor does he or she visit or telephone the inventor to request prior art from the inventor.” Such statements are inadmissible because they seek to call into question the statutory presumption of validity established in 35 U.S.C. § 282 (2006). See EZ Dock, Inc. v. Schafer Sys., Inc., Civil No. 98-2364, 2003 WL 1610781, at *15 (D.Minn. Mar. 8, 2003) (excluding “testimony disparaging the PTO and its examiners”); Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., No. 92-20643, 1995 WL 261407, at *3 (N.D.Cal. Apr. 25, 1995) (“Testimony about overwork, quotas, awards or promotions at the Patent Office, or the number of patents that issue annually or insinuating that the Patent Office does not do its job properly is excluded. Such evidence would be irrelevant speculation and would constitute an inappropriate attack on the Patent Office.”).
In addition, Gerstman opines that “the ‘at least 90%’ limitation was the critical limitation that the Examiner believed was missing from the prior art of which the Examiner was aware” and that a particular reference “was the missing link which would have helped the Examiner formulate a rejection of the claims which plaintiffs may have been unable to overcome.” These statements are inadmissible because Gerstman cannot know what the examiner believed or would have done. See, e.g., Se-Kure Controls, 2009 WL 77463, at *2 (“Mr. Gerstman is also not a mind-reader.”); Pharmacia, 2004 WL 5614917, at *2 (prohibiting testimony “as to how a ‘reasonable patent examiner’ would have acted in light of the facts of this case”); Applied Materials, 1995 WL 261407, at *2-3 (excluding testimony “about what the examiner would have done if [the expert] had been the examiner, or if the examiner had different information”). Finally, Gerstman, who LP admits is not a person of skill in the relevant art, is not qualified to testify about the materiality of any references. See Applied Materials, 1995 WL 261407, at *2-3. The Court grants AMS’s motion to exclude Gerstman’s testimony.
B. Infringement
The parties brought cross-motions on the issues of literal infringement and infringement under the doctrine of equivalents. The terms at issue with respect to infringement are the 90% limitations, transmitting surface/particular area, “glass cladding extending to a distal end of the tip” (glass cladding limitation), and “means for positioning.”
1. Legal standard
Determining infringement is a two-step process. Bai, 160 F.3d at 1353. First, the claim is properly construed, and second, the claim as properly construed is compared to the accused device. Id. Whether a claim is literally infringed or infringed under the doctrine of equivalents is a question of fact. Id.
Literal infringement requires the accused device to literally embody every limitation of the claim. Kraft Foods, Inc. v. Int’l Trading Co., 203 F.3d 1362, 1370 (Fed.Cir.2000). “[A] literal infringement issue is properly decided upon summary judgment when no genuine issue of material fact exists, in particular, when no reasonable jury could find that every limitation recited in the properly construed claim either is or is not found in the accused device.” Bai, 160 F.3d at 1353.
“An accused device that does not literally infringe a claim may still infringe under the doctrine of equivalents if each limitation of the claim is met in the accused device either literally or equivalently.” Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1459 (Fed.Cir.1998) (en banc). An element in the accused product is equivalent to a claim limitation if the differences between the two are insubstantial to one of ordinary skill in the art. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 40, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997). Insubstantiality may be determined by whether the accused device performs substantially the same function in substantially the same way to obtain the same result as the claim limitation. Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608, 70 S.Ct. 854, 94 L.Ed. 1097 (1950). When deciding whether summary judgment of infringement under the doctrine of equivalents is proper, a court first determines if prosecution history estoppel applies and then determines whether a reasonable jury could find that the accused device contains elements that are equivalent to each of the properly construed claim limitations. Bai, 160 F.3d at 1354. Wfliether prosecution history estoppel applies is a question of law. Id.
2. Literal infringement
a. 90% limitations
Repeating the arguments it made in support of its motion to exclude Milster’s testimony, LP contends that no reasonable jury could find the accused devices meet the 90% limitations because Milster’s experiments do not measure what is claimed, Milster failed to account for certain losses within the waveguide, and Milster overcaptured and undercaptured light. In the absence of any evidence quantifying the effect of the alleged flaws in Milster’s experiments, the Court concludes that a reasonable jury could find the 90% limitations were met. LP also contends that Milster’s experiments show that only between 83% and 87% of the “input energy” was detected in the desired lateral direction. As stated with respect to LP’s motion to strike Milster’s testimony, this “input energy” argument ignores the coupling losses and Fresnel losses identified by Milster in his expert report. The jury should decide whether Milster’s explanation of those losses is credible.
AMS maintains that there is no issue of fact as to whether the 90% limitations are present in the accused device. AMS submits Milster’s transmission experiments, Lei’s declaration, and LP’s quality testing in support of its motion. The Court concludes that Knox’s opinions regarding possible flaws in Milster’s transmission experiments create an issue of fact as to whether the 90% limitations are met. Moreover, the jury should decide whether Lei made appropriate assumptions when modeling the accused devices for his ray tracing. AMS also relies on LP’s representations to the Food and Drug Administration (FDA) that the accused products are “equivalent” to AMS’s AddStat products, which embody the claimed invention. With respect to FDA submissions, “[c]ourts have repeatedly refused to allow FDA 510(k) notification of substantial equivalence as admission of infringement in patent cases” because “equivalence” has a different meaning in the FDA context than in the patent infringement context. CardioVention, Inc. v. Medtronic, Inc., 483 F.Supp.2d 830, 840 (D.Minn.2007). Consequently, a reasonable jury could find that the accused devices do not meet the 90% limitations regardless of LP’s representations to the FDA. Finally, AMS submits Stein’s deposition testimony that the accused devices have “nearly zero scattering” and LP’s representations in its advertising materials that the accused products are “scatter free” in support of its motion. A reasonable jury could find that the 90% limitations are not met despite those statements because neither necessitates the conclusion that the accused devices meet the structural requirements of the 90% limitations. Issues of fact remain as to whether the 90% limitations are present in the accused devices.
b. Transmitting surface/particular area
AMS identifies the outer surface of the fused window in the accused devices as the transmitting surface/particular area on the tip of the waveguide. LP contends that neither limitation is found in the accused devices because the transmitting surface/particular area identified by AMS is not, as required by the claims, “on the tip of the waveguide.”
The Court construed “tip of the waveguide” as:
the distal end portion of the waveguide, including a separate component coupled thereto in a manner that prevents internal reflection at any interface between the components (for example, by fusing or a transparent, index-matched adhesive), but not including a cap or tube enclosing a transmitting surface on the distal end portion of the waveguide or a reflecting surface on the distal end portion of the waveguide.
Accordingly, the capsule of the accused devices is not the “tip of the waveguide.” AMS, however, contends that the portion of the capsule that is fused to the optical fiber becomes a part of the “tip of the waveguide” because the fused window does not “enclose” the reflecting or transmitting surface. LP responds that this argument is precluded by the Court’s construction of “tip of the waveguide.”
When taking the evidence in the light most favorable to AMS, a reasonable jury could find that the fused window is part of the tip of the waveguide based on its attachment to the tip. However, when considering the evidence in the light most favorable to LP, a reasonable jury could find that the fused window is part of the capsule regardless of its attachment to the optical fiber. An issue of fact remains as to whether the fused window is part of the tip of the waveguide, and therefore, whether the accused devices include a transmitting surface/particular area on the tip of the waveguide.
AMS also contends that, even if the fused window is not part of the tip of the waveguide, the outer surface of the fused window is “on” the tip of the waveguide in the same manner that a second book in a stack of books resting on a table is “on” the table. LP responds that this interpretation would permit any object, including the patient’s internal organs, to be “on” the tip of the waveguide. The Court concludes that an issue of fact remains regarding whether a surface is “on” the tip of the waveguide even if it does not directly contact the tip.
Finally, LP contends that no reasonable jury could find that the transmitting surface/particular area is present in the accused devices because AMS did not identify the precise location or dimensions of the transmitting surface/particular area. This argument does not establish the absence of fact issues regarding infringement because the claims do not require a precise location or specific dimensions. See Bai, 160 F.3d at 1353. The Court concludes that issues of fact remain as to whether the accused devices meet the transmitting surface/particular area limitation.
c. Glass cladding limitation
The parties dispute whether a reasonable jury could find the glass cladding limitation present in the accused devices. The Court construed “glass cladding” as a “glass material that surrounds and protects a fiber core and confines electromagnetic radiation to the waveguide during its communication to the tip of the waveguide where the glass material need not contact the fiber core.”
It is undisputed that the accused devices include an optical fiber having a core and a core cladding of fluorine-doped silica. When the accused devices are manufactured, the inside wall of the capsule is fused to the distal end of the optical fiber. AMS maintains, based on Milster’s interpretation of the SEM-EDS results, that fluorine remains in the fused window. LP, relying on Knox’s declaration, contends that the presence of fluorine does not mean that light is confined in the fused window. Relying on Milster’s deposition testimony and statements in his expert report that the fusing “prevents internal reflection” at the interfaces between the capsule and the fiber and “erases all optical interfaces that would strongly reflect the light,” LP attributes this non-confinement to the absence of optical interfaces in the fused window. AMS objects to LP’s characterization of Milster’s deposition testimony and expert reports, and responds that Milster testified during his deposition that the fused window “still maintains [the relationship between the core and fluorine-doped silica cladding] to communicate the light traveling down the fiber to the reflecting surface.” The Court concludes that issues of fact remain as to whether the fused window confines light.
AMS alternatively contends that, even if the fluorine in the fused window does not confine light at the tip, the fluorine-doped silica in the fused window is still “glass cladding” because the construction of “glass cladding” only requires confinement of light “during its communication to the tip of the waveguide.” In support of this argument, AMS identifies embodiments disclosed in the '699 Patent where light is transmitted through the cladding. AMS also contends that the glass cladding limitation is met regardless of whether the fused window meets the “confinement” requirement because the glass cladding extends to the reflecting surface on the tip and sides of the optical fiber. The Court concludes that issues of fact remain regarding those arguments.
d. Means for positioning
Finally, LP seeks summary judgment that the accused devices do not directly infringe claims 25 and 27-30, which require a means for positioning the waveguide during surgery, because it does not sell any such means. AMS responds that it does not allege direct infringement of those claims. Consequently, LP’s motion for summary judgment on the issue of direct infringement of claims 25 and 27-30 is denied as moot.
LP moves for summary judgment of noninfringement of claims 25 and 27-30 under theories of indirect infringement because AMS has produced no evidence of third-party use of the accused devices with a means for positioning. See Novartis Pharm. Corp. v. Eon Labs Mfg., Inc., 363 F.3d 1306, 1308 (Fed.Cir.2004). The directions for use for the accused devices indicate that they are intended for use with an endoscope, which is identified as a means for positioning in the '699 Patent. This is sufficient evidence of third-party infringing use to withstand LP’s motion for summary judgment of noninfringement.
AMS moves for summary judgment that claims 25 and 27-30 are indirectly infringed under a theory of contributory infringement or inducement. Because fact issues remain regarding the 90% limitations, the transmitting surface/particular area, the glass cladding limitation, and the means for positioning, the Court denies AMS’s motion.
3. Infringement under the doctrine of equivalents
LP contends that AMS is precluded from relying on the doctrine of equivalents for any limitations other than the glass cladding limitation. AMS responds that it may rely on the doctrine of equivalents for all of the claim limitations.
The pretrial schedule required AMS to identify on its claim chart “which claim(s) of its patent(s) it alleges are being infringed” and “where each element of each claim ... is found in each product or method.” The pretrial schedule also required AMS to “separately indicate [contentions of infringement under the doctrine of equivalents] on its Claim Chart and, in addition to the information required for literal infringement ... also explain each function, way, and result that it contends are equivalent.” In its claim chart, AMS generally asserted that LP infringes “literally and/or under the doctrine of equivalents,” but made specific allegations of infringement under the doctrine of equivalents only with respect to the glass cladding limitation. AMS first indicated that it intended to assert infringement under the doctrine of equivalents for the other limitations in Milster’s expert report on infringement on January 25, 2010. To the extent AMS asserts infringement under the doctrine of equivalents for limitations other than the glass cladding limitation, AMS has not complied with the pretrial schedule. The Court therefore considers whether AMS’s untimely disclosure of its allegations of infringement under the doctrine of equivalents was substantially justified or harmless. See Trost, 162 F.3d at 1008.
AMS asserts no justification for its untimely disclosure. It appears, however, that AMS’s untimely disclosure was harmless. LP identifies no harm arising from the untimely disclosure, and Knox responded in his noninfringement report to Milster’s opinions regarding the doctrine of equivalents for each element. The Court therefore permits AMS to assert infringement under the doctrine of equivalents with respect to the transmitting surface/particular area, the glass cladding limitation, and the 90% limitations.
AMS moves for summary judgment that the accused devices infringe under the doctrine of equivalents, while LP moves for summary judgment of noninfringement under the doctrine of equivalents for the glass cladding limitation. LP also maintains that prosecution history estoppel bars application of the doctrine of equivalents for the glass cladding limitation. A court generally determines if prosecution history estoppel applies before deciding a motion for summary judgment of infringement under the doctrine of equivalents. Bai, 160 F.3d at 1354. LP, however, only made prosecution history estoppel arguments with respect to the glass cladding limitation. Having decided that AMS may assert infringement under the doctrine of equivalents for the other limitations, the Court permits LP to bring a motion in limine regarding the application of prosecution history estoppel to those limitations. The Court will consider all of LP’s prosecution history estoppel arguments at that time. Should LP make no additional arguments regarding prosecution history estoppel, the Court will rely on the parties’ summary judgment briefs with respect to the glass cladding limitation. In light of the contradictory opinions of Milster and Knox and the incomplete briefing on the issue of prosecution history estoppel, the Court denies the motions for summary judgment on the issue of infringement under the doctrine of equivalents.
4. Willful infringement
LP seeks summary judgment on the issue of willful infringement on the ground that AMS failed to plead it. AMS responds that it pleaded willful infringement in its Complaint because it pleaded continuing infringement and infringement by inducement or contributory infringement, which require knowledge of the '699 Patent.
AMS relies on two cases to support its contention that it sufficiently pleaded willful infringement. In both cases, however, the patentee actually pleaded “willful” infringement. See Sentry Protection Prods., Inc. v. Eagle Mfg. Co., 400 F.3d 910, 918 (Fed.Cir.2005) (finding patentee did not waive marking argument by failing to plead notice where patentee alleged “that the infringements have been willful and with full knowledge of the [patents at issue]”); Jardin v. Datallegro, Inc., No. 08-1462, 2009 WL 186194, at *1, 7 (S.D.Cal. Jan. 18, 2009) (finding complaint stated a claim for willful infringement where “Plaintiff allege[d] Defendants have committed patent infringement and willful infringement of the patent”). AMS did not allege “willful” infringement in its Complaint, nor did it seek enhanced damages under 35 U.S.C. § 284 (2006). Cf. SRI Int’l, Inc. v. Advanced Tech. Labs., Inc., 127 F.3d 1462, 1464 (Fed.Cir.1997) (explaining that “willful infringement” is the phrase “designating behavior for which enhanced damages [under § 284] may be assessed”). Nothing in AMS’s Complaint gave LP “fair notice” of a claim for willful infringement. See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). Consequently, the Court grants LP’s motion for summary judgment of no willful infringement.
C. Invalidity
Tlie parties cross-moved for summary judgment on the issues of invalidity under §§ 112, 102, and 103 (2006). The Court sets forth the legal standards here only to the extent they have not been previously stated.
1. Legal standard
An issued patent is presumed valid. 35 U.S.C. § 282. An accused infringer has the burden of proving invalidity by clear and convincing evidence. Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 962 (Fed.Cir.2001). “When evaluating a motion for summary judgment, the court views the record evidence through the prism of the evidentiary standard of proof that would pertain at a trial on the merits.” Id. A moving party seeking to invalidate a patent on a motion for summary judgment must submit such clear and convincing evidence of invalidity so that no reasonable jury could find otherwise. Id. A moving party seeking to have a patent found not invalid at summary judgment must show that the nonmoving party failed to produce clear and convincing evidence on an essential element of a defense upon which a reasonable jury could invalidate the patent. Id.
2. Section 112
a. Functionality
Citing Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1, 67 S.Ct. 6, 91 L.Ed. 3 (1946), LP contends the asserted claims are invalid • because the 90% limitations, which LP characterizes as the “exact point of novelty,” are “purely functional.” “[T]here is no support, either in the actual holdings of prior cases or in the [Patent Act], for the proposition, put forward here, that ‘functional’ language, in and of itself, renders a claim improper,” and no “other ground for objecting to a claim on the basis of any language, ‘functional’ or otherwise, beyond what is already sanctioned by the provisions of 35 U.S.C. § 112.” In re Swinehart, 58 C.C.P.A. 1027, 439 F.2d 210, 213 (1971); see also Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255-56 (Fed.Cir.2008) (citing Swinehart with approval and explaining that functional claim language may render the claim indefinite under § 112, ¶ 2); 3 Donald S. Chisum, Chi-sum on Patents § 8.04[3] (2010) (“Under Swinehart’s analysis, functional language is not per se objectionable in claims. Functionality in claim language may raise problems under the established patent law standards requiring claim definiteness, full enabling disclosure, and patentable distinctness over