IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE BAUSCH & LOMB INCORPORATED, PF CONSUMER HEALTHCARE 1 LLC, Plaintiffs, vo C.A. No. 20-1463-GBW SBH HOLDINGS LLC, Defendant.

MEMORANDUM ORDER Pending before the Court are the following findings and recommendations issued by Magistrate Judge Burke: (1) Report and Recommendation (“R&R”) dated December 29, 2023 (hereinafter, the “Dec. 29 R&R”) (D.I. 102); (2) R&R dated February 8, 2024 (hereinafter, the “Feb. 8 R&R”) (D.I. 108); (3) Oral Order dated April 18, 2024 (hereinafter, the “April 18 Oral Order”) (D.I. 124), and (4) Oral Order dated July 1, 2024 (hereinafter, the “July 1 Oral Order”) (D.I. 141). Defendant SBH Holdings LLC (“Defendant”) filed objections to three of Magistrate Judge Burke’s recommendations (D.I. 111, D.I. 127, D.I. 146), and Plaintiffs Bausch & Lomb Incorporated and PF Consumer Healthcare 1 LLC (“Plaintiffs”) opposed each objection (D.I. 112, D.J. 128, D.I. 147). Having reviewed Magistrate Judge Burke’s recommendations, Defendant’s objections, and all related briefing, the Court hereby finds that Defendant’s objections are OVERRULED and Magistrate Judge Burke’s recommendations and orders are ADOPTED.

I. LEGAL STANDARD! The Supreme Court has construed the statutory grant of authority conferred on magistrate judges under 28 U.S.C. § 636 to mean that non-dispositive pretrial matters are governed by § 636(b)(1)(A) and dispositive matters are covered by § 636(b)(1)(B). Gomez v. United States, 490 U.S. 858, 873-74 (1989); see also Fed. R. Civ. P. 72(a). Pursuant to subparagraph (B), a district court may refer a dispositive motion to a magistrate judge “to conduct hearings, including evidentiary hearings, and to submit to a judge of the court proposed findings of fact and recommendations for the disposition.” 28 U.S.C. § 636(b)(1)(B); see EEOC v. City of Long Branch, 866 F.3d 93, 99-100 (3d Cir. 2017). The product of a magistrate judge, following a referral of a dispositive matter, is often called a “report and recommendation.” /d. “Parties ‘may serve and file specific written objections to the proposed findings and recommendations’ within 14 days of being served with a copy of the magistrate judge's report and recommendation.” Jd. (quoting Fed. R. Civ. P. 72(b)(2)).

“If a party objects timely to a magistrate judge's report and recommendation, the district court must ‘make a de novo determination of those portions of the report or specified proposed findings or recommendations to which objection is made.’” EEOC, 866 F.3d at 99 (quoting 28 U.S.C. § 636(b)(1)). If a party does not object timely to a magistrate judge's report and recommendation, the party may lose its right to de novo review by the district court. Id. However, ’ “because a district court must take some action for a report and recommendation to become a final order and because ‘[t]he authority and the responsibility to make an informed, final determination

... remains with the judge,’ even absent objections to the report and recommendation, a district

' The Court writes for the benefit of the parties who are already familiar with the pertinent background facts.

court should ‘afford some level of review to dispositive legal issues raised by the report.’” Id. (internal citations omitted). The district court must give “reasoned consideration” to the report

_ and recommendation. Jd. at 100.

II. DISCUSSION A. Dec. 29 R&R (D.L. 102) on Defendant’s Motion on JOP: On April 4, 2023, Defendant moved for Judgment on the Pleadings (“JOP”) on grounds that United States Patent Nos. 6,660,297 (the “’297 patent”) and 8,603,522 (the “’522 patent” and collectively with the ’297 patent, “the asserted patents”) were invalid as a matter of law. See generally D.I. 63. On December 29, 2023, Magistrate Judge Burke determined that Defendant’s arguments should be raised “[a]t some later point in the case[] when the record is fully developed.” See D.J. 102 at 7, 11-12. Thus, Magistrate Judge Burke issued the Dec. 29 R&R recommending that Defendant’s Motion for JOP be denied. /d. at 12. Neither party objected to the Dec. 29 R&R. Having reviewed the Dec. 29 R&R, Defendant’s Motion for J OP, and all related briefing, the Court agrees that Defendant’s Motion for JOP raised several issues of fact that could not be adjudicated at the Rule 12(c) stage. Accordingly, the Dec. 29 R&R (D.I. 102) denying Defendant’s Motion for JOP is adopted.

B. Feb. 8 R&R (D.I. 108) on Claim Construction: The parties briefed their positions on claim construction on May 25, 2023. D.I. 79. Of the seven terms briefed for construction, four terms were disputed: (1) “approximately”, in various contexts; (2) “vitamin A in the form of beta-carotene, substituted or supplemented with lutein, zeaxanthine or a raw material combination thereof”; (3) “0.04 mg to 40 mg lutein-zeaxanthine combination”; and (4) “early age-related macular degeneration.” Jd Magistrate Judge Burke conducted a Markman hearing on September 26, 2023 and issued an R&R regarding claim construction on February 8, 2024. DJ. 108. The Feb. 8 R&R proposed the following constructions:

1. “approximately” with respect to the amounts of vitamin C, vitamin E, zinc, copper, lutein, zeaxanthine and lutein-zeaxanthine combination should be construed to mean “reasonably close to” and “approximately” with respect to the amounts of vitamin A in the form of beta-carotene should be construed to mean “an amount of vitamin A in the form of betacarotene that comes reasonably close to 6 to 10 times the RDA for vitamin A, but not less than 5 times the RDA for vitamin A”

2. “0.04 mg to 40 mg lutein-zeaxanthine combination” should be construed to mean “0.04 mg to 40 mg lutein-zeaxanthine achieved deliberately because of normal composition or through raw material contamination”

3. “vitamin A in the form of beta-carotene, substituted or supplemented with lutein, zeaxanthine or a raw material combination thereof’ should be construed to mean “lutein, zeaxanthine,, or a raw material combination thereof, may be used instead of, or in addition to, vitamin A in the form of beta-carotene”

4, “early age-related macular degeneration” should be construed to mean “early AMD, intermediate AMD, and advanced AMD in one eye only”

Id. at 29.

On February 22, 2024, Defendant filed objections to Magistrate Judge Burke’s proposed constructions of two disputed terms, “approximately” and “substituted and supplemented with.”

See generally D.I. 111. For the following reasons, Defendant’s objections are overruled, and the Feb. 8 R&R (D.I. 108) on claim construction is adopted.

od. “approximately” means “reasonably close to.” The claims of the asserted patents generally disclose compositions and methods of administering compositions which contain “approximately” identified amounts of various ingredients, including vitamin A in the form of beta-carotene, vitamin C, vitamin E, zinc, copper, lutein, zeaxanthine, and/or lutein-zeaxanthine combination. See, e.g., patent 9:58-67, 10:21- 32. The parties addressed the “approximately” terms in two categories: (1) “approximately” (with respect to the amounts of vitamin C, vitamin E, zinc, copper, lutein, zeaxanthine and lutein- zeaxanthine combination), and (2) “approximately” (with respect to the amounts of vitamin A in the form of beta-carotene). D.I. 79 at 7-8. Magistrate Judge Burke agreed that the construction of “approximately” should be addressed in two categories, given that the latter category “was specifically addressed in the context of the '297 patent reexamination proceedings.” D.I. 108 at 12. With respect to the amounts of vitamin C, vitamin E, zinc, copper, lutein, zeaxanthine and lutein-zeaxanthine combination, Magistrate Judge Burke found that “approximately” should be given its plain and ordinary meaning of “reasonably close to.” D.I. 108 at 4. Defendant objects to this construction and contends that Magistrate Judge Burke ignored evidence that the patentee disclaimed and disavowed a construction of “approximately” according to its plain and ordinary meaning of “reasonably close to” during prosecution of the ’297 patent. D.I. 111 at 1. Defendant notes, for instance, that the patentee sought to distinguish its claimed composition from several prior art sources during examination proceedings by emphasizing the “unique” and “specific” formulation of its composition. Jd According to Defendant, the patentee highlighted “[t]he

specific amounts” of certain formulations and “did not use the word ‘approximately,’” and the Examiner “parroted” the same arguments in its allowance. /d. at 2 (arguing that the allowance “Tcjonfirm[s] this [was] the [E]xaminer’s reasons for allowance of the ’297 patent”).

However, Magistrate Judge Burke carefully considered each prosecution statement raised by Defendant and correctly found that the statements did not amount to clear and unmistakable disclaimer. D.I. 108 at 8. Magistrate Judge Burke noted, for example, that at several points during prosecution, “the patentee [made] clear that the claimed amounts were approximations.” Jd. at 9. Because disclaimer “requires that the alleged disavowing actions or statements made during prosecution be both clear and unmistakable,” Aylus Networks, Inc. v. Apple Inc., 856 F.3d 1353, 1359 (Fed. Cir. 2017), the Court agrees that the prosecution history of the °297 patent does not demonstrate that the patentee unequivocally and unambiguously disavowed the plain meaning of “approximately.”

As Plaintiffs note, two additional tribunals to consider the construction of “approximately” similarly declined to find that the patentee disclaimed the plain meaning of “approximately” during prosecution. D.I. 112 at 3. During reexamination proceedings for the’297 patent, for instance, the Examiner concluded that the patentee did not “clearly and unambiguously disclaim[] or disavow[] any interpretation of the term ‘approximately’ in order to distinguish the recited ranges of the claimed components from the ranges [in] the prior art.” D.I. 108 (citing D.I. 54, ex. El at 8). The United States District Court for the Western District of New York also found that “there [could] be no finding that the disclaimer was made for the purpose of obtaining the ’297 patent.” See Bausch & Lomb Inc. v. Vitamin Health, Inc., 13-CV-6498T, 2015 WL 13574354, at *7 (W.D.N.Y. Jan. 15, 2015). For these reasons, and for the additional reasons outlined by Magistrate Judge

Burke, Defendant’s claims of prosecution history disclaimer are not persuasive. Thus, Defendant’s objections are overruled, and the Court adopts the R&R’s construction of “approximately.”

employment history, and (3) Mr. Denning’s conclusory opinions on the indefiniteness and enablement defenses. D.I. 124.

For these reasons, Defendant’s objections to the April 18 Oral Order (DI. 124) are overruled.

D. July 1 Oral Order (D.I. 141): Shortly following Magistrate Judge Burke’s April 18 Oral Order striking the Denning Declaration, D.I. 124, Defendant served the Reply Report of SBH Unretained Expert Zac Denning (the “Denning Reply Report”) on April 26, 2024. D.I. 135 at 1. Plaintiffs subsequently moved to strike the Denning Reply Report on grounds that the Denning Reply Report violates the Court’s Scheduling Order. D.I. 134 at 1. Magistrate Judge Burke agreed and, on July 1, 2024, granted Plaintiff's Motion to Strike the Denning Reply Report. See generally D.I. 141. The Oral Order explained that “[p]aragraph 7(f)(i) of the [Scheduling Order] is clearly meant to permit an expert

to file a reply expert report only if an expert for that side has previously properly submitted an opening/initial expert report or disclosure on the subject at issue.” Jd. Additionally, because the April 18 Oral Order struck the Denning Disclosure, the Oral Order found “no valid initial expert report/disclosure having been served by Mr. Denning or any other expert for Defendant as to the subject matter at issue in Mr. Denning’s reply report.” Jd. Thus, Magistrate Judge Burke granted Plaintiffs’ Motion to Strike the Denning Reply Report. /d.

On July 12, 2024, Defendant objected to the Oral Order on grounds that Magistrate Judge Burke lacked authority to resolve Daubert motions and motions in limine. See generally D.I. 146. However, consistent with the Court’s holding with respect to the Denning Disclosure, the Court finds that Magistrate Judge Burke was within his authority to resolve the Motion to Strike. As Plaintiffs note, the Motion to Strike “was not based on whether Mr. Denning’s proposed testimony can survive a challenge under Daubert, nor was it a trial motion.” D.I. 147 at 3. Rather, Plaintiffs moved to strike the Denning Reply Report on grounds that the report violated the Court’s Scheduling Order. Jd. Because the Court’s Referral Order referred “all pre-trial matters up to and including expert discovery matters,” Magistrate Judge Burke was authorized to resolve the Motion to Strike. See D.I. 40.

Defendant next contends that the Oral Order “was clearly erroneous” because the Denning Reply Report was “timely and properly submitted in full compliance with the scheduling order.” D.I. 146 at 4. The Court disagrees. As the Oral Order explained, Defendant had no valid initial report for Mr. Denning following the April 18 Oral Order. D.I. 141. Thus, to serve the Denning Reply Report pursuant to the Court’s Scheduling Order, the Court agrees with Magistrate Judge Burke that Defendant was required to serve the Denning Reply Report on or before the deadline for opening expert disclosures. Jd. Because Defendant failed to do so, there is no dispute that the Denning Reply Report was untimely. Finally, the Court agrees that Defendant failed to demonstrate good cause to permit its violation of the Scheduling Order under Fed. R. Civ. P. 16(b)(4). fd. Therefore, Defendant’s objections are overruled. kkk

At Wilmington, this 27th day of September 2024, IT IS HEREBY ORDERED that: 1. The Report and Recommendation dated December 29, 2023, DI. 102, is ADOPTED, and Defendant’s Motion for Judgment on the Pleadings, D.I. 63, is DENIED.

3. The Oral Order dated April 18, 2024, D.I. 124, is ADOPTED, and Defendant’s objections, D.I. 127, are OVERRULED. 4. The Oral Order dated July 1, 2024, D.1. 141, is ADOPTED, and Defendant’s objections, D.I. 146, are OVERRULED. =\n VQ : GREGORY B. WILLIAMS UNITED STATES DISTRICT JUDGE