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SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC

United States District Court, W.D. Kentucky, Bowling Green Division

April 7, 2017

SCA HYGIENE PRODUCTS AKTIEBOLAG, et al. PLAINTIFFS
v.
FIRST QUALITY BABY PRODUCTS, LLC, et al. DEFENDANTS

          MEMORANDUM OPINION & ORDER

          GREG N. STIVERS, JUDGE

         This is a patent infringement case involving disposable pants-type diapers. Plaintiffs SCA Hygiene Products Aktiebolag and SCA Personal Care, Inc. (collectively, “SCA”) allege that certain products manufactured and sold by Defendants First Quality Baby Products, LLC, First Quality Hygienic, Inc., First Quality Products, Inc., and First Quality Retail Services, LLC (collectively, “First Quality”) infringe the asserted claims of U.S. Patent No. 6, 375, 646 and its accompanying Reexamination Certificate (collectively, the “‘646 Patent”). This matter is before the Court upon: (1) First Quality's Motion to Exclude Portions of the Expert Report of Earle Sherrod Relating to Infringement and for Summary Judgment of Non-Infringement (DN 96); (2) First Quality's Motion to Exclude Portions of Expert Reports of Earle Sherrod & Richard Gering Relating to Commercial Success (DN 97); (3) SCA's Motion to Preclude Expert Testimony of Daniel D. Gardner, Jr. on the Issue of Infringement of the Patent-in-Suit (DN 100); and (4) First Quality's Motion for Partial Summary Judgment of Non-Infringement (DN 98).

         I. BACKGROUND

         The ‘646 Patent describes a pants-type diaper for use by both potty-training children and adults with incontinence issues. (Claims Construction Mem. Op. & Order 4, DN 61). Before the Court can address the motions at hand, a brief discussion of the diaper outlined in the specification of the ‘646 Patent is necessary. The easiest way to describe the diaper is to work from an illustration of the preferred embodiment, which is provided in the patent and reproduced below.

         Image Omitted.

         The diaper has a front part and a back part (1 and 2) with side edges (4 and 5) and one end edge on each side (6 and 7). U.S. Patent No. 6, 375, 646 col. 5 ll. 46-48, 55-57 (filed Apr. 23, 2002). The diaper's side edges are joined together to create the final product. Id. at col. 5 ll. 63-66. A crotch part (3) is located between the front and back parts, and the side edges of the crotch (8) form the leg openings when the product is assembled. Id. at col. 5 ll. 49-52, 57-62. The front and back parts of the diaper have elastically stretchable regions (29 and 30)-the elastically stretchable regions are comprised of elastic elements, such as elastic threads, film, laminate, bands, or ribbons. Id. at col. 7, ll. 17-28, 37-41. The diaper also has elastically stretchable front and back waist parts (31 and 32). Id. at col. 7, ll. 59-61. Finally, the diaper includes an elongated absorbent pad (14). Id. at col. 6, ll. 4-8. The absorbent pad has a front end part (17) and a back end part (18). Id. at 6, ll. 35-36.

         The ‘646 Patent contains 38 claims. Claims 1 and 15 are independent claims; the rest are dependent. Independent claim 1 states, in relevant part:

[T]he pants-type diaper further comprises at least one elastically stretchable region covering essentially the whole of at least one of the respective front and back parts; the crotch part being essentially non-stretchable in relation to said stretchable region; at least one of the respective end parts of the absorbent layer being disposed within one of said elastically stretchable regions; the central part of the absorbent layer being disposed within the relatively non-stretchable crotch part of the diaper; and at least one of the stretchable regions being disposed on the side of the absorbent layer facing away from the inner casing layer, whereby those forces that are exerted by the elastically stretchable region on at least one of the end part of the absorbent layer function to hold the absorbent layer in sealing abutment with the wearer when the pants-type diaper is worn.

Id. at col. 8, ll. 64-67, col. 9, ll. 1-13. Similarly, independent claim 15 provides:

[A]t least one of the respective front and back parts has at least one elastically stretchable region; the crotch part being essentially non-stretchable in relation to said stretchable region; at least one of the respective end parts of the absorbent layer being disposed within one of said elastically stretchable regions; the central part of the absorbent layer being disposed within the relatively non-stretchable crotch part of the diaper; and at least one of the stretchable regions being disposed on the side of the absorbent layer facing away from the inner casing layer, whereby those forces that are exerted by the elastically stretchable region on at least one of the end part of the absorbent layer function to hold the absorbent layer in sealing abutment with the wearer when the pants-type diaper is worn; and at least one of the end edge of the front and the back parts has at the waist opening of the pants at least one elastically stretchable waist part whose stretching and contraction power is greater than the remainder of the stretchable region.

Id. at col. 10, ll. 21-39.

         SCA filed this action on August 2, 2010, alleging that a number of First Quality's products infringe the ‘646 Patent. (Compl., DN 1). For sake of convenience, the parties have grouped the products accused of infringing into nine representative categories: (1) SCA-AP-020; (2) SCA-AP-050; (3) SCA-AP-056; (4) SCA-AP-016; (5) SCA-AP-051; (6) SCA-AP-001; (7) SCA-AP-004; (8) SCA-AP-010; and (9) SCA-00-AP-008/023[1] (collectively, “the Accused Products”). (See Email from Evans to Mandaro, DN 100-9; Email and Letter from Mandaro to Flannery, DN 100-10; Email from Mandaro to Evans, DN 100-11). SCA has asserted claims 1-6, 10-11, 15-21, and 35-38 against SCA-AP-020, 023, 050, and 056; claims 15, 18-21, and 25 against SCA-AP-001, 004, 016, and 051; and claims 1-11, 15-25, and 35-38 against SCA-AP-010. (Sherrod Decl. 18, DN 107-3).

         On December 29, 2011, the Court conducted a claim construction hearing as required by Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996). (Order, DN 60). Following the hearing and a review of the parties' submissions the Court entered a Markman Order, construing the disputed terms of the ‘646 Patent. (Claims Construction Mem. Op. & Order 22-23, DN 61). Subsequently, the Court granted summary judgment for First Quality on grounds of laches and equitable estoppel. (Mem. Op. & Order, DN 119). SCA appealed. (Notice of Appeal, DN 122). The Federal Circuit affirmed this Court's grant of summary judgment as to laches, reversed as to equitable estoppel, and remanded for further consistent proceedings. (Op. 21, DN 134). SCA petitioned the United States Supreme Court for writ of certiorari as to the Federal Circuit's decision on First Quality's laches defense, and the Supreme Court granted SCA's petition (DN 149). Recently, the Supreme Court vacated the Federal Circuit's ruling in part and remanded for further consistent proceedings. SCA Hygiene Prods. Aktiebolag v. First Quality Baby Prods., 197 L.Ed.2d 292, 305 (2017).

         Before the Supreme Court made its ruling, SCA moved to stay proceedings in this Court. (See Mot. Stay Pending Petition for Writ of Cert. 1, DN 139-1). The Court denied SCA's request on grounds of judicial economy because there were a number of motions to be resolved wholly unrelated to the matter before the Supreme Court. (Order 1-2, DN 150). The Court will now address the merits of those motions.

         II. JURISDICTION

         The Court has subject-matter jurisdiction under 28 U.S.C. § 1331 because a federal question is presented.

         III. DISCUSSION

         A. Motions Concerning Expert Testimony

         According to the Federal Circuit, regional circuit law applies to evidentiary rulings in patent cases. Liquid Dynamics Corp. v. Vaughn Co., 449 F.3d 1209, 1218 (Fed. Cir. 2006) (citing Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., 265 F.3d 1294, 1308 (Fed Cir. 2001)). Generally, Rules 702 and 104(a) of the Federal Rules of Evidence govern the admissibility of expert testimony. See Nelson v. Tenn. Gas Pipeline Co., 243 F.3d 244, 250 (6th Cir. 2001) (citing Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589 (1993)). Rule 702 provides:

         A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:

(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert has reliably applied the principles and methods to the facts of the case.

Fed. R. Evid. 702.

         Under Daubert v. Merrell Dow Pharmaceuticals, Rules 702 and 104(a) require that the trial court act as a gatekeeper and ensure that expert testimony is both relevant and reliable. Daubert, 509 U.S. at 589; Conwood Co. v. U.S. Tobacco Co., 290 F.3d 768, 792 (6th Cir. 2002). The test for relevancy is one of “fit, ” meaning the testimony must be sufficiently related to the facts of the case such that it will aid the trier of fact in understanding the evidence or determining a fact in issue. Daubert, 509 U.S. at 591.

         When determining reliability, a key consideration for the trial court in carrying out its gatekeeping function is “whether the reasoning or methodology underlying the testimony is sufficiently valid . . . .” Daubert, 509 U.S. at 592-93. The Supreme Court, however, has advised that the inquiry is flexible and that “[t]he focus . . . must be solely on principles and methodology, not on the conclusions they generate.” Id. at 594-95. There is no definitive checklist for determining whether an expert's testimony is reliable, but Daubert outlines factors for courts to consider, such as: (1) whether the theory or method in question “can be (and has been) tested”; (2) whether it “has been subjected to peer review and publication”; (3) whether it has a “known or potential rate of error”; and (4) whether the theory or technique enjoys “general acceptance” in the “relevant scientific community.” Id. at 593-94.

         Daubert applies to all expert testimony. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999). The factors, however, are not exhaustive. See Id. Moreover, where a party challenges the testimony of a proffered expert for insufficient “factual basis, data, principles, methods, or their application . . . the trial judge must determine whether the testimony has a reliable basis in the knowledge and experience of [his or her] discipline.” Id. at 149 (quoting Daubert, 509 U.S. at 592). Daubert involves balancing the desire to liberally admit relevant evidence against the necessity of excluding misrepresentative “junk science.” Best v. Lowe's Home Ctrs., Inc., 563 F.3d 171, 176-77 (6th Cir. 2009) (citing Amorgianos v. Nat'l R.R. Passenger Corp., 303 F.3d 256, 267 (2d Cir. 2002)).

         While the trial court is not required to hold a Daubert hearing to determine the admissibility of expert testimony, it must ensure that the testimony is both relevant and reliable. See Clay v. Ford Motor Co., 215 F.3d 663, 667 (6th Cir. 2000); Nelson, 243 F.3d at 248-49 (citing Greenwell v. Boatwright, 184 F.3d 492, 498 (6th Cir. 1999)). Ultimately, “a trial judge . . . ha[s] considerable leeway in deciding whether particular expert testimony is reliable, ” and the decision is reviewed for abuse of discretion. Kumho Tire, 526 U.S. at 142, 152; Conwood, 290 F.3d at 792; see also Tamraz v. Lincoln Elec. Co., 620 F.3d 665, 672 (6th Cir. 2010) (“Rule 702, we recognize, does not require anything approaching absolutely certainty. And where one person sees speculation, we acknowledge, another may see knowledge, which is why the district court enjoys broad discretion over where to draw the line.” (internal citation omitted) (citation omitted)).

         1. First Quality's Motion to Exclude Portions of Sherrod's Report Relating to Infringement and for Summary Judgment of Non-Infringement

         To prevail in its infringement suit, SCA must prove that the Accused Products practice the following limitation: “those forces that are exerted by the elastically stretchable region on at least one end part of the absorbent layer function to hold the absorbent layer in sealing abutment with the wearer when the pants-type diaper is worn” (the “sealing abutment limitation”). See U.S. Patent No. 6, 375, 646 col. 9 ll. 8-12, col. 10, ll. 31-35. Additionally, to prevail as to independent claim 15, SCA must prove that the Accused Products have an “elastically stretchable waist part whose stretching and contraction power is greater than the remainder of the stretchable region” (the “stretching and contraction power limitation”). See Id. at col. 10, ll. 35- 39. To meet its burden, SCA offers the opinion of Earle Sherrod (“Sherrod”). Sherrod has over ten years of experience in the area of incontinence-product development. (Sherrod Report 2-3, DN 107-3). He relied on his experience, the Court's claim construction opinion, review of technical documents, deposition testimony, and visual inspection and testing of the Accused Products in reaching his conclusions on these limitations. (Sherrod Report 20, 39-40, 43-45; Sherrod Report Ex. B, at 27-42, DN 96-8). First Quality contends that Sherrod's opinions contained in paragraphs 71-72; 102-103; 111-116; Exhibits M-V, BB, CC, and portions of Exhibits DD-EE of his report, all of which relate to the sealing abutment and stretching and contraction power limitations, are inadmissible. (Defs.' Mem. Supp. Mot. Exclude Portions of Expert Report of Earle Sherrod Relating to Infringement & for Summ. J. 1, DN 96-1 [hereinafter Defs.' Mot. Exclude-Infringement]). Likewise, because Sherrod's opinion is the only evidence offered by SCA as proof that the sealing abutment and stretching and contraction power limitations are found in the Accused Products, First Quality has moved for summary judgment of non-infringement. (Defs.' Mot. Exclude-Infringement 1-2).

         Sherrod opines that each of the Accused Products meets the sealing abutment limitation. (Sherrod Report 41). First, Sherrod notes that one of ordinary skill in the art visually inspecting the Accused Products when worn by an appropriately-sized wearer would conclude that the sealing abutment limitation is met because, for example, when the products are placed on a mannequin one can see that the front end of the absorbent core is held against the body of the wearer. (Sherrod Report 40-41). Second, Sherrod opines that based on the design of the accused products, one of ordinary skill in the art examining the products would determine that all of the accused products are designed to fit against the body of the wearer and reduce leakage. (Sherrod Report 40). Third, through his review of deposition testimony, Sherrod maintains that First Quality has confirmed that all of the Accused Products were designed to fit against the body of the wearer when worn. (Sherrod Report 40).

         Finally, Sherrod declares that testing confirms the sealing abutment limitation is met. (Sherrod Report 40). Sherrod designed and laboratory technicians conducted a test that uses cylinders and a pressure sensor to determine the forces exerted by the elastically stretchable region. (Sherrod Report 29-30; Sherrod Report Ex. CC, DN 96-12; Sherrod Report Ex. CC, DN 96-13). Under Sherrod's test protocols, a pressure sensor was taped to the appropriate cylinder at least two centimeters below the rim. (Sherrod Report 30). Each product was marked at the following two locations: (1) under the center of belly elastics between the waist and the front edge of the core and (2) under an end part of the absorbent core. (Sherrod Report 30; Sherrod Report Ex. CC, DN 96-12; Sherrod Report Ex. CC, DN 96-13). The product was then placed over the cylinder such that the first marking position on the product (under the center of belly elastics) was aligned with the sensor. (Sherrod Report 30; Sherrod Report Ex. CC, DN 96-12; Sherrod Report Ex. CC, DN 96-13). The product remained in this position for approximately 90 seconds while an image of the forces acting on the pressure sensor was recorded and saved. (Sherrod Report 30; Sherrod Report Ex. CC, DN 96-12; Sherrod Report Ex. CC, DN 96-13). The product was then repositioned on the cylinder such that the second marking position on the product (under an end part of the absorbent core) was aligned with the sensor. (Sherrod Report 30; Sherrod Report Ex. CC, DN 96-12; Sherrod Report Ex. CC, DN 96-13). Again, the product remained in this position for approximately 90 seconds while an image of the pressure forces acting on the pressure sensor was recorded and saved. (Sherrod Report 30; Sherrod Report Ex. CC, DN 96-12; Sherrod Report Ex. CC, DN 96-13). This process was repeated for nine additional samples of the Accused Products in each representative category. (Sherrod Report 30; Sherrod Report Ex. CC, DN 96-12; Sherrod Report Ex. CC, DN 96-13).

         After the tests were completed, Sherrod examined the recorded images. (Sherrod Report 40). According to Sherrod, the amount of pressure at a given point is directly related to the amount of force exerted by the elastically stretchable region on that point. (Sherrod Report 41). Each captured image displays the pressure resulting from the forces exerted by the elastically stretchable region on the wearer's body at the location of the pressure sensor. (Sherrod Report 40). If forces are exerted, the image shows color. (Sherrod Report 41; see also, e.g., Sherrod Report Ex. M, at 64-73, DN 100-4). Because each image showed color, Sherrod concludes that on all of the Accused Products the elastically stretchable region exerts forces on the absorbent layer that holds it against the body of the wearer. (Sherrod Report 41).

         Sherrod also opines that each Accused Product practices the stretching and contraction power limitation. (Sherrod Report 45). First, Sherrod notes that visual inspection of the products reveals that each product meets the stretching and contraction limitation because: (1) the material in each product is bunched more in the horizontal direction at the waist part of the product than it is in the remainder of the elastically stretchable region in the front or back part of the product as exhibited by the “necking” down of the product at the waist part; and (2) the elastic elements or material at the waist part are more closely spaced and, in most cases, thicker than the elastic elements or material in the remainder of the elastically stretchable region on the front or back parts. (Sherrod Report 43-44).

         Second, Sherrod states that the technical documents associated with the Accused Products indicate that the elastic elements or material in the waist part of the product, in general, have a greater pre-elongation and are of a higher denier than the elastic elements or material in the remainder of the elastically stretchable region on the front or back part. (Sherrod Report 44). Moreover, through his review of deposition testimony, Sherrod believes that First Quality has admitted that many of the Accused Products meet the stretching and contraction limitation. (Sherrod Report 44).

         Last, Sherrod maintains that tests confirm his visual inspection and analysis of technical documents. (Sherrod Report 44). Under Sherrod's test protocol, 25 millimeter strips were cut from the front and back of the product at three locations: (1) waist; (2) belly elastics in the elastically stretchable region; and (3) thigh elastics in the elastically stretchable region. (Sherrod Report 29; Sherrod Report Ex. BB, DN 96-12; Defs.' Mot. Exclude-Infringement 9). The strips were cut so that the side seam of the product remained intact, forming a circular sample. (Sherrod Report 29). The strips were then placed on an Instron 5965 testing instrument and stretched to two inches below the maximum fit range of the product. (Sherrod Report 29; Sherrod Report Ex. BB, DN 96-24). This process was repeated for nine additional samples of the Accused Products in each representative category. (Sherrod Report 29; Sherrod Report Ex. BB, DN 96-24).

         While Sherrod did not personally conduct the tests, he observed technicians perform testing on at least one product from each representative category to ensure that they were comfortable with the protocol. (Sherrod Report 29). After Sherrod determined that the technicians were performing capably, they completed the tests and gave Sherrod the raw data. (Sherrod Report 29). Sherrod then analyzed the data and concluded that the stretching and contraction limitation was met for all of the tested Accused Products. (Sherrod Report 29). Sherrod's Report contains graphs that illustrate the stretching power of each tested strip. (See, e.g., Sherrod Report Ex. M, at 57-63, DN 100-4).

         First Quality argues that Sherrod's opinions on sealing abutment and stretching and contraction power are inadmissible under Daubert and Rule 702 because his tests are unreliable and, aside from the tests, his opinions rest on nothing more than generalized conclusions. With regard to the sealing abutment limitation, First Quality contends his pressure-sensing test is unreliable because: (1) it merely determines that some force is exerted by the diaper, which is not sufficient to show sealing abutment; (2) Sherrod did not explain his basis for the test; and (3) Sherrod did not use control samples.

         Contrary to First Quality's assertion, however, Sherrod's pressure-sensing test is an appropriate way to show that the Accused Products meet the sealing abutment limitation. Importantly, “[o]nce a district court has construed the relevant claim terms, and unless altered by the district court, then that legal determination governs for purposes of trial. No party may contradict the court's construction to a jury.” Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1321 (Fed. Cir. 2009). An expert's testimony must be consistent with the court's claim construction opinion. See, e.g., Medisim Ltd. v. BestMed LLC, 861 F.Supp.2d 158, 171 (S.D.N.Y. 2012).

         The pressure-sensing test is consistent with this Court's claim construction opinion. In the Markman opinion, the Court accorded the phrase “to hold the absorbent layer in sealing abutment with the wearer” its ordinary and customary meaning as understood in the context of the claimed invention by one skilled in the art at the time of the invention. (Claim Construction Mem. Op. & Order 21). Moreover, the Court specifically noted that “[o]ne skilled in the art at the time of the invention reading the phrase [sealing abutment] in the context of the claimed invention would understand that the phrase describes the end part of the absorbent layer being held against the wearer.” (Claims Construction Mem. Op. & Order 19). It follows that, depending on the construction of a pants-type diaper, the end part of the absorbent layer could be spaced away from the body, could lie closely without contact, or could be pressed into contact with the body of the wearer. In the context of the ‘646 Patent, however, the elastic elements or material in the elastically stretchable region exert forces strong enough to actually press the end part of the pad against the body. In turn, Sherrod's test is appropriate to determine sealing abutment. The end part of the absorbent pad will not press against the wearer if the elastically stretchable region does not exert force of sufficient strength upon it. Likewise, if the pressure sensor records forces acting on it, the sealing abutment limitation is met; if it does not, the limitation is not met.

         First Quality urges that leakage is the true measure of sealing abutment and that Sherrod's failure to test for leakage renders his opinion unreliable. First Quality's argument is unpersuasive because it ignores the claim construction opinion. During claim construction, First Quality's proposed construction of the term “sealing abutment” was that “[t]he pad of the pants-type diaper is held against the wearer in such a way that there is no leakage[, ]” and the Court rejected this construction. (Defs.' Opening Claim Construction Br. 31-32, DN 52; Claims Construction Mem. Op. & Order 19-21). Furthermore, while it is true that a pad held in sealing abutment with the wearer's body will reduce leakage, it does not necessarily follow that a test for leakage measures sealing abutment. In his declaration, Sherrod notes that a leak test shows how much fluid a product can hold before it leaks, which is a function of many factors, including for example, the absorbency of the product and the effectiveness of the “gasketing” at the legs and waist. (Sherrod Decl. 28). Moreover, SCA explained to the PTO during reexamination of the ‘646 Patent and to this Court at the Markman hearing that a leak test does not measure sealing abutment because it “relates to the (potential) sealing effects of the waist and leg openings, ” not “the forces exerted on at least one of the end parts of the absorbent layer that holds the absorbent layer in sealing abutment with the wearer.” (Claims Construction Mem. Op. & Order 20). As a result, the Court cannot say that Sherrod's testing is unreliable merely because it does not address leakage.

         Relying on the fact that a prior absorbent pants-type diaper patent was tested using mannequins, First Quality claims that the pressure-sensing test is inappropriate because it uses cylinders. Sherrod did not arbitrarily decide to use cylinders. Rather, he explained that he used cylinders to foster consistency and accommodate the range of size of people that would wear the elastics at issue. (Sherrod Dep. 553:2-554:18, Dec. 11, 2012, DN 96-16). Sherrod's pressure-sensing test is not unreliable simply because he used cylinders rather than mannequins; he was not required to use mannequins for his test just because other diapers have been tested that way. See Best, 563 F.3d at 181 (“Admissibility under Rule 702 does not require perfect methodology.”). In this respect, weaknesses in Sherrod's methodology may affect the weight his opinion is given at trial, but not its threshold admissibility. Id. at 182 (citing Kudabeck v. Kroger Co., 338 F.3d 856, 861-62 (8th Cir. 2003)).

         First Quality's reliance on Warner Chilcott Laboratories Ireland Ltd. v. Impax Laboratories, Inc., Nos. 2:08-cv-06304, 2:09-cv-02073, 2:09-cv-01233, 2012 U.S. Dist. LEXIS 60386 (D.N.J. Apr. 30, 2012), for the proposition that Sherrod's testing is unreliable is misplaced. In Warner Chilcott, an unpublished case from a sister court, the expert failed to provide the parameters used for his testing or explain the reason for the methodology he had chosen. Id. at *73-74. Parts of the expert's tests were simply arbitrary. See Id. In the present case, however, Sherrod explained why the pressure-sensing test measures sealing abutment in his opening report and his deposition. (Sherrod Report 39-41; Sherrod Dep. 552:18-554:18, 559:21- 560:23). Further, in light of the Court's claim construction the pressure-sensing test is a non-arbitrary, reliable measurement of the sealing abutment limitation. See In re Scrap Metal Antitrust Litig., 527 F.3d 517, 529 (6th Cir. 2008) (“[T]he requirement that an expert's testimony be reliable means that it must be ‘supported by appropriate validation-i.e., “good grounds, ” based on what is known.'” (quoting Daubert, 509 U.S. at 590)).

         Finally, First Quality's argument that the pressure-sensing test is unreliable because it lacks control samples is unpersuasive. First Quality cites Dal-Tile Corp. v. United States, 424 F.3d 1286, 1292 (Fed. Cir. 2005), for the proposition that “basic principles or methods of scientific inquiry [require] using a representative sample population, using control groups, or testing hypotheses via., e.g., statistical checks.” (Defs.' Reply Mot. Exclude Portions Expert Reports of Earle Sherrod Relating to Infringement & for Summ. J. 9, DN 115). In that decision, however, the Federal Circuit was quoting the Court of International Trade and did not specifically hold that Daubert requires the use of control samples in all cases. Dal-Tile Corp., 424 F.3d at 1292. The Court accepts the notion that controls can be an element of Daubert's concern with reliability. See United States v. Hebshie, 754 F.Supp.2d 89, 123 (D. Mass. 2010). Nevertheless, the Court's inquiry under Daubert is a “flexible one” geared to the facts of each case. See Id. (“The government cannot just say that in some situations, or in general, a single sample will suffice. They have to show that in this case, on these facts, a single sample was reliable.”); Daubert, 509 U.S. at 594-95.

         In Hebshie, upon which First Quality relies heavily, the government's expert tested a sample of carpet to determine if it contained chemicals connecting the defendant to a fire. Hebshie, 754 F.Supp.2d at 99, 103. The government used only one carpet sample in its testing, which it gathered from the place investigators had already determined to be the fire's point of origin. Id. at 123. The court found that such a practice ignores that the chemical found in the carpet could have been the result of the defendant's actions or something else, which is why a “control” was so important to avoid the risk of a “false positive”-the expert should have tested another sample of carpet collected away from the alleged point of origin. Id.

         In the present case, ten samples from each of the nine representative product groups were tested. (Sherrod Report 30). Before each sample was subjected to the pressure-sensing test, the technicians performing the test checked the sensor to confirm that it was properly balanced and not recording any forces when no product was on the cylinder. (Sherrod Decl. 27). These procedures alone are sufficient to distinguish Sherrod's testing from the practice rejected in Hebshie.

         First Quality's position that, aside from testing, Sherrod's opinion on sealing abutment rests on nothing more than generalized conclusions is unfounded. Sherrod bases his opinion on visual observation, inspection of the Accused Products, and a review of deposition testimony. For example, Sherrod explained in his opening report that “when products are placed on a mannequin, it can be seen that the front end part of the absorbent core is held against the body of the wearer.” (Sherrod Report 40). Given the Court's prior construction of sealing abutment, such an observation provides a reliable foundation for Sherrod's opinion. See Exergen Corp., 575 F.3d at 1321; In re Scrap Metal, 527 F.3d at 529-30 (“[T]he task for the district court in deciding whether an expert's opinion is reliable is not to determine whether it is correct, but rather to determine whether is rests upon a reliable foundation, as opposed to, say, unsupported speculation.” (citing Fed.R.Evid. 702)). The Court's role here is not to determine the correctness of Sherrod's opinion. See Powell v. Tosh, 942 F.Supp.2d 678, 720 (W.D. Ky. 2013) (citing In re Scrap Metal, 527 F.3d at 529-30). Sherrod's opinion on sealing abutment is reliable because it rests on reasonable grounds; therefore, it is admissible.

         The Court must next determine whether Sherrod's opinion that the stretching and contraction power limitation is found in all of the Accused Products rests upon a reliable foundation. Sherrod's test used an Instron device to determine the stretchability of the materials at issue, which testing is common in the industry. (Sherrod Report Ex. BB, at 49-50, DN 96-12; Sherrod Decl. 21; Silwanowicz Dep. 146:20-149:10, May 3, 2012, DN 107-27). Indeed, First Quality tests its own products using an Instron. (Sherrod Decl. 21; Silwanowicz Dep. 146:20-149:10). Sherrod developed detailed test protocols with the Court's claim construction opinion and the technical specifications of First Quality's products in mind. The technicians performing the tests recorded the results, and Sherrod analyzed those results and reproduced the data in his report.

         First Quality contends that Sherrod's stretching-and-contraction-power test is unreliable because: (1) it ignores the definition of the terms “waist part” and “remainder of the elastically stretchable region” found in the ‘646 Patent and skews the test results towards infringement-the 25 millimeter “waist” strips include extra elastic from the remainder of the elastically stretchable region (increasing stretching power), while the other 25 millimeter strips are smaller than the actual “remainder” and have less elastic than they should (decreasing stretching power); (2) it fails to provide results for contraction power; and (3) it was not performed correctly-the test lacked adequate quality control measures, the strips cut for testing were not uniformly 25 millimeters wide (the width of the waist strip and belly-elastic strip in actual samples tested ranged from 20 millimeters to 30 millimeters), and one belly-elastic strip had cut elastics and split side seams, presumably resulting in reduced stretching power.

         The Court is not convinced that the size of the strips that Sherrod tested is fatal to the admissibility of his testimony. In Quiet Tech. DC-8, Inc. v. Hurel-Dubois UK Ltd., 326 F.3d 1333 (11th Cir. 2002), the appellant argued that the expert used incorrect data or was missing data to run the study at hand and used the wrong equations to run the analysis. Id. at 1344. According to appellant, if the data was incorrect, the expert's conclusions were necessarily flawed and had to be excluded. Id. at 1344-45. The court disagreed and found that the appellant's argument went to the weight of the evidence, rather than admissibility. Id. at 1345. Moreover, in Jahn v. Equine Services, 233 F.3d 382 (6th Cir. 2000), the Sixth Circuit reversed a trial judge's decision to exclude proposed expert testimony. The court explained that although the opinions of the proffered testimony “may very well be ‘shaky, '” because the opinions were based upon facts in the record, and were not “assumptions” or “guesses, ” challenges merely went to the accuracy of the conclusions, not to the reliability of the testimony. Id. at 390-93. Ultimately, while it is true that a significant error in the application of an expert's method will sometimes affect the admissibility of the expert's testimony, “rejection of expert testimony is the exception, rather than the rule.” Id. (quoting Fed.R.Evid. 702 advisory committee's note, 2000 amend.).

         In his declaration, Sherrod explains that the stretching and contraction testing protocol is based on the claim limitations found in the ‘646 Patent and the product specifications for the Accused Products. (Sherrod Decl. 24). After examining the specifications, Sherrod concludes that the target width of the waist part is, on average, up to approximately 25 millimeters. (Sherrod Decl. 24). He designed the test to compare the stretching and contraction power of a 25 millimeter waist strip against that of 25 millimeter strips from the remainder of the elastically stretchable region, one from the thigh region and one from the area between the waist and the absorbent pad, “to achieve a statistically correct representation of the ‘remainder.'” (Sherrod Decl. 24). Sherrod explains that comparing the stretching and contraction power of the waist part to the stretching and contraction power of the remainder of the elastically stretchable region is an “apples-to-apples” comparison of regions of the same size. (Sherrod Decl. 24).[2] Based on the product specifications for the Accused Products, Sherrod explains that “waist strands” are generally of a high denier or pre-elongation or are spaced closer together than the belly elastics in the same product, so the inclusion of belly elastic in the waist strip would actually decrease the stretching and contraction power of the strip. (Sherrod Decl. 25; Sherrod Dep. 181:3-18). Furthermore, based on the product specifications, Sherrod notes that the number of elastic strands in any given part of the products varies, as evidenced by the fact that the specifications set a target number of strands and provide a minimum and maximum acceptable number for quality control purposes. (Sherrod Decl. 25).

         Sherrod's failure to record results for contraction power does not render his testing unreliable. The stretching and contraction power limitation is concerned with the relative comparison of the stretching and contraction power of the waist to the remainder, and there is support for the proposition that the contraction curves would show the same relative difference between the sections as demonstrated by the stretching curves. Sherrod explains in his declaration that the contraction results were duplicative of the information provided by the stretching power results provided in his report. (Sherrod Decl. 23). In fact, First Quality's own expert is essentially in agreement with Sherrod on this point. (Gardner Dep. 90:13-94:2, Dec. 18, 2012, DN 107-21). If First Quality believes it can show that contraction power does not mirror stretching power, it certainly will be able raise the issue on cross examination. See Best, 563 F.3d at 180 (citing Daubert, 509 U.S. at 596)).

         First Quality is incorrect in asserting that Sherrod's declaration cannot be considered. Generally, Rule 26 of the Federal Rules of Civil Procedure does not prohibit an expert from revising and clarifying his opinions, so long as the testimony is not a departure from the “general scheme” of the expert's report. McHugh v. Olympia Entm't, Inc., 37 F. App'x 730, 735-36 (6th Cir. 2002); Hochstein v. Microsoft Corp., No. 04-73071, 2006 U.S. Dist. LEXIS 74574, at *15-16 (E.D. Mich. Oct. 13, 2006). Sherrod's declaration simply clarifies his opinion and is not a departure from the general scheme of his report. Therefore, the Court cannot say that Rule 26 prohibits its use.

         First Quality's argument that the stretching and contraction power test is unreliable because it was performed incorrectly-it lacked adequate quality control measures, some samples might not have been exactly 25 millimeters, and one sample had split side seams-is similarly unpersuasive. First, Sherrod's test protocols describe in detail how to perform the test and how to address quality control. (Sherrod Report Ex. BB, at 49-50, DN 96-12). Under Sherrod's protocols, almost 200 samples were tested and maintained in individually labeled bags. (Pls. Opp'n Defs.' Mot. Exclude Portions Expert Report of Earle Sherrod Relating to Infringement & Summ. J. 22, DN 107 [hereinafter Pls.' Opp'n]; Sherrod Report Ex. BB, at 49-50, DN 96-12). If side seams or elastics were cut, technicians were instructed to place the product into a separate bag. (Sherrod Report Ex. BB, at 50, DN 96-12). Second, Sherrod explained in his deposition that it is difficult, if not impossible, to cut strips of exactly equal length. (Sherrod Dep. 172:18-24, 263:5-19). Moreover, the pictures that First Quality produced in support of its argument are of samples taken after testing. (See Defs.' Mot. Exclude- Infringement 12). In his declaration, Sherrod explained that “the ragged edges of the tested samples are the result of the impact of the elastic contraction of the sample on the woven-like nature of the spunbond material sheet of the tested sample, not any improper cutting.” (Sherrod Decl. 22, 23). Third, the sample with cut elastics and split side seams that First Quality points to in support of its argument was not even tested, as SCA's counsel noted on the record during Sherrod's deposition. (Sherrod Dep. 389:4-24).

         First Quality is once again incorrect that, aside from testing, Sherrod's opinion rests on nothing more than generalized conclusions. Sherrod's visual inspection of the Accused Products and review of technical documents, as outlined above, further bolster the reliability of his opinion. It would no doubt be impermissible for Sherrod to blankly state that each Accused Product meets the stretching and contraction power limitation. That is not the case here; Sherrod examined the Accused Products and the technical documents associated with them and explained why each meets the stretching and contraction power limitation.

         Overall, after reviewing Sherrod's deposition, report, and declaration and the parties' submissions, the Court cannot say that Sherrod's opinion on the stretching and contraction power limitation rests on “assumptions or guesses.” See Jahn, 233 F.3d at 393; see also United States v. L.E. Cooke Co., 991 F.2d 336, 342 (6th Cir. 1993). It is simply not the purely speculative junk science that Daubert seeks to eliminate. See Johnson v. Stella Jones Corp., No. 5:13-CV-00101-TBR, 2015 U.S. Dist. LEXIS 19185, at *12 (W.D. Ky. Feb. 13, 2015). In any event, the crux of First Quality's argument is that Sherrod's testing produced incorrect results, so that his proposed testimony is unreliable. (See Defs.' Mot. Exclude-Infringement 8 (“In short, the use of 25 millimeter test strips . . . produces an incorrect result, a result that is biased in SCA's favor.”)). Again, it is not up to the Court to determine the correctness of Sherrod's opinion. See In re Scrap Metal, 527 F.3d at 529-30. The appropriate way for First Quality to deal with Sherrod is through cross-examination and presentation of contrary evidence. See Best, 563 F.3d at 180 (citing Daubert, 509 U.S. at 596).

         First Quality also attacks Sherrod's opinions on sealing abutment and stretching and contraction power collectively. It takes shots at both of Sherrod's tests by noting that they have not been peer reviewed and lack error rates. Both are Daubert factors; they are not requirements. Daubert, 509 U.S. at 593-94; Kumho Tire, 526 U.S. at 150. The Supreme Court has recognized that the Daubert factors do not apply in every case. Kumho Tire, 526 U.S. at 141-42 (“Daubert's list of specific factors neither necessarily nor exclusively applies to all experts or in every case. Rather, the law grants a district court the same broad latitude when it decides how to determine reliability as it enjoys in respect to its ultimate determination.” (citation omitted)). Therefore, the lack of peer review or error rates is not fatal.

         First Quality also argues that Sherrod's opinions are unreliable because the testing was performed by unsupervised technicians employed by SCA. True, Sherrod did not perform and was not present for all testing, but he gave the technicians detailed protocols and ensured their capability in testing before leaving them unsupervised. (Sherrod Decl. 22; Sherrod Report Ex. BB, at 49-50). The technicians had over two years of testing experience and had used the equipment involved regularly for quality testing and prototype evaluation. (Sherrod Decl. 22). They kept a notebook that recorded testing conditions and products tested for a given day, which was given to First Quality's counsel. (Sherrod Decl. 22; Pls.' Opp'n 21). The technicians also videotaped the testing of one sample of each tested product, which Sherrod reviewed to confirm that the testing was conducted according to his protocols. (Sherrod Decl. 22).

         First Quality cites no authority for the proposition that Sherrod should have been present for all testing or that the tests he designed are automatically unreliable because persons employed by SCA performed them. Other courts have held that experts need not be present for testing. See, e.g., Astra Aktiebolag v. Andrx Pharm., Inc., 222 F.Supp.2d 423, 492 (S.D.N.Y. 2002) (citing Ecolab Inc. v. Amerikem Lab., Inc., 98 F.Supp.2d 569, 574 (D.N.J. 2000)), aff'd sub nom. In re Omeprazole Patent Litig., 84 F. App'x 76 (Fed. Cir. 2003). Moreover, Federal Rule of Evidence 703 provides that an expert “may base an opinion on facts or data in the case that the expert has been made aware of or personally observed.” Fed.R.Evid. 703. First Quality's suggestion that SCA's employees falsified the test results lacks any support. Indeed, the test results reproduced in Sherrod's report suggest that there was no foul play-the results for the stretching and contraction power tests, for example, were consistent in each representative product category. (See, e.g., Sherrod Report Ex. M, at 57-63, DN 100-4; Sherrod Report Ex. N, at 75-80, DN 100-4).

         For all of these reasons, the Court concludes that Sherrod's opinions on sealing abutment and stretching and contracting power are admissible. Accordingly, this motion is denied.[3]

         2. First Quality's Motion to Exclude Portions of Expert Reports of EarleSherrod & Richard ...


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