Fate Therapeutics, Inc. v. Shoreline Biosciences, Inc.

• Decision Date: 22 February 2023
• Docket Number: 22-cv-00676-H-MSB
• Parties: FATE THERAPEUTICS, INC.; and WHITEHEAD INSTITUTE FOR BIOMEDICAL RESEARCH, Plaintiffs, v. SHORELINE BIOSCIENCES, INC.; and DAN S. KAUFMAN, Defendants.
• Court: U.S. District Court — Southern District of California

FATE THERAPEUTICS, INC.; and WHITEHEAD INSTITUTE FOR BIOMEDICAL RESEARCH, Plaintiffs, v. SHORELINE BIOSCIENCES, INC.; and DAN S. KAUFMAN, Defendants.

No. 22-cv-00676-H-MSB

United States District Court, S.D. California

February 22, 2023

TENTATIVE CLAIM CONSTRUCTION ORDER

MARILYN L. HUFF, UNITED STATES DISTRICT COURT JUDGE

In the present action, Plaintiffs Fate Therapeutics, Inc. (“Fate”) and Whitehead Institute for Biomedical Research (“Whitehead”) assert claims for patent infringement against Defendants Shoreline Biosciences, Inc. (“Shoreline”) and Dan S. Kaufman, alleging claims for infringement of U.S. Patent Nos. 8,071,369 (“the '369 Patent”), 8,932,856 (“the '856 Patent”), 8,951,797 (“the '797 Patent”), 8,940,536 (“the '536 Patent”), 9,169,490 (“the '490 Patent”), U.S. Patent No. 10,017,744 (“the '744 Patent”), and 10,457,917 (“the '917 Patent”) (collectively, “the asserted patents”). (Doc. No. 162, Supp. FAC ¶¶ 157-414.) On January 6, 2023, the parties filed their amended joint claim construction hearing statement, chart, and worksheet pursuant to Patent Local Rule 4.2. (Doc. No. 113.) On February 7, 2023, the parties each filed their opening claim construction briefs. (Doc. Nos. 149, 150, 151.) On February 17, 2023, the parties each filed their responsive claim construction briefs. (Doc. Nos. 178, 179, 180.)

A claim construction hearing is scheduled for February 27, 2023 at 11:00 a.m. In anticipation of the hearing, the Court issues the following tentative claim construction order.

Background

In the present action, Plaintiffs allege that Defendants infringe the asserted patents under 35 U.S.C. § 271(a) and 35 U.S.C. § 271(b) and that Defendants infringe the asserted method patents under 35 U.S.C. § 271(g).^[1] (See Doc. No. 162, Supp. FAC ¶¶ 157-414.) Specifically, Plaintiffs allege that Defendants, individually and acting in concert, make, use sell, offer for sale, and/or import induced pluripotent stem cells (“iPSCs”) that infringe one or more claims of the asserted patents.^[2] (Id. ¶ 140; see, e.g. Id. ¶¶ 162 (“Defendants' use of their ‘iPSC-derived cell therapy manufacturing platform' infringed at least claim 1 of the '369 Patent.”), 212 (“iPSCs used by Defendants to make at least the iPSC-derived natural kill (NK) cell platforms are made by a process that comprises at least each step of claim 1 of the '856 Patent.”).)

Plaintiff Whitehead is the owner via assignment of the patents-in-suit. See U.S. Patent No. 8,071,369, at [73] (issued Dec. 6, 2011); U.S. Patent No. 8,932,856, at [73] (issued Jan. 13, 2015); U.S. Patent No. 8,951,797, at [73] (issued Feb. 10, 2015); U.S. Patent No. 8,940,536, at [73] (issued Jan. 27, 2015); U.S. Patent No. 9,169,490, at [73] (issued Oct. 27, 2015); U.S. Patent No. 10,017,744, at [73] (issued Jul. 10, 2018); U.S. Patent No. 10,457,917, at [73] (issued Oct. 29, 2019). Plaintiffs allege that Fate is the exclusive licensee of the patents-in-suit. (Doc. No. 162, Supp. FAC ¶¶ 16, 19.)

The '369 Patent is entitled “Compositions for reprogramming somatic cells” and was issued on December 6, 2011. '369 Patent at [45], [54]. The '856 Patent is entitled “Methods for reprogramming somatic cells” and was issued on January 13, 2015. '856 Patent at [45], [54]. The '797 Patent is entitled “Compositions for identifying reprogramming factors” and was issued on February 10, 2015. '797 Patent at [45], [54]. The '536 Patent is entitled “Methods for making somatic cells more susceptible to reprogramming” and was issued on January 27, 2015. '536 Patent at [45], [54]. The '490 Patent is entitled “Methods for reprogramming somatic cells” and was issued on October 27, 2015. '490 Patent at [45], [54]. The '744 Patent is entitled “Methods for reprogramming somatic cells” and was issued on Jul. 10, 2018. '744 Patent at [45], [54]. The '917 Patent is entitled “Methods for reprogramming somatic cells” and was issued on October 29, 2019. '917 Patent at [45], [54].

The asserted patents are all related and all share a common specification.^[3] (See Doc. No. 149 at 5 & n.2; Doc. No. 151 at 2 & n.2 (agreeing that the asserted patents all share the same specification); see also Doc. No. 162, Supp. FAC ¶ 132).) The shared specification states that the disclosed invention is directed to “methods for reprogramming somatic cells to a less differentiated state.” '369 Patent col. 2 ll. 24-25; see also Id. at [57] (“The invention provides methods for reprogramming somatic cells to generate multipotent or pluripotent cells.”).

Independent claim 1 of the '369 Patent claims:

A composition comprising an isolated primary somatic cell that comprises an exogenously introduced nucleic acid encoding an Oct4 protein operably linked to at least one regulatory sequence.

'369 Patent col. 20 ll. 40-43.

Independent claim 1 of the '856 Patent claims:

A method of making a somatic cell more susceptible to reprogramming to a pluripotent state comprising introducing at least one exogenous nucleic acid encoding Oct 4 operably linked to at least one regulatory sequence into the cell, thereby increasing expression of Oct4 protein in the somatic cell, wherein increased expression of Oct4 protein makes the cell more susceptible to reprogramming to a pluripotent state.

'856 Patent col. 20 ll. 38-44.

Independent claim 1 of the '797 Patent claims:

A composition comprising an isolated primary somatic cell that comprises an exogenously introduced nucleic acid encoding Oct 4, wherein the exogenously introduced nucleic acid increases Oct4 expression in the cell.

'797 Patent col. 20 ll. 40-43.

Independent claim 1 of the '536 Patent claims:

A method of making a primary somatic cell more susceptible to reprogramming to a less differentiated state, comprising: introducing an exogenous nucleic acid encoding an Oct 4 protein operably linked to at least one regulatory sequence into the somatic cell, wherein expression of the exogenously introduced nucleic acid results in making the somatic cell more susceptible to reprogramming to a less differentiated state.

'536 Patent col. 20 ll. 37-44.

Independent claim 1 of the '490 Patent claims:

A somatic cell comprising an exogenous nucleic acid encoding Oct4 and an amount of Oct4 expression comparable to the amount of Oct4 expression in an embryonic stem cell.

'490 Patent col. 20 ll. 39-41.

Independent claim 1 of the '744 Patent claims:

A method of making a somatic cell more susceptible to reprogramming to a cell having a less differentiated state, comprising:

obtaining a somatic cell that comprises an exogenously introduced polynucleic acid encoding Oct4 protein, and an exogenously introduced polynucleic acid encoding Sox2 or Nanog protein; wherein the exogenously introduced polynucleic acids result in making the somatic cell more susceptible to reprogramming to a less differentiated state.

'744 Patent col. 21 ll. 14-23.

Independent claim 1 of the '917 Patent claims:

A method of making a somatic cell more susceptible to reprogramming to a less differentiated state, comprising: introducing an exogenous nucleic acid encoding an Oct 4 protein operably linked to at least one regulatory sequence into the somatic cell, thereby increasing expression of Oct4 protein in the somatic cell, wherein increased expression of Oct4 protein makes the cell more susceptible to reprogramming; and wherein the exogenous nucleic acid is transiently transfected into the somatic cell.

'917 Patent col. 21 ll. 16-24.

On May 13, 2022, Plaintiffs filed a complaint against Defendants, alleging claims for infringement of the '369 Patent, the '856 Patent, the '797 Patent, the '536 Patent, the '490 Patent, and the '917 Patent. (Doc. No. 1, Compl. ¶¶ 66-236.) On August 12, 2022, the Court issued a scheduling order. (Doc. No. 51.)

On December 5, 2022, the parties filed their joint claim construction hearing statement, chart, and worksheet pursuant to Patent Local Rule 4.2. (Doc. No. 90.) On January 3, 2023, Plaintiffs filed a first amended complaint against Defendants, adding a claim for infringement of the '744 Patent. (Doc. No. 112, FAC ¶¶ 375-414.) On January 6, 2023, the parties filed an amended joint claim construction hearing statement, chart, and worksheet pursuant to Patent Local Rule 4.2. (Doc. No. 113.) On January 10, 2023, the Court issued an amended scheduling order. (Doc. No. 115.) On February 14, 2023, Plaintiffs filed a supplemental first amended complaint - the operative complaint. (Doc. No. 162, Supp. FAC.) On February 17, 2023, Defendant Shoreline filed an answer and counterclaims to Plaintiffs' supplemental first amended complaint. (Doc. No. 184.)

By the present claim construction briefs, the parties agree to the proper construction for two claim terms, and the parties request that the Court construe six disputed claim terms from the asserted patents. (See Doc. Nos. 149, 150, 151, 178, 179, 180; see also Doc. No. 113-1, Ex. A; Doc. No. 113-7, Ex. D.)

Discussion

A. Legal Standards for Claim Construction

Claim construction is an issue of law for the court to decide. Teva Pharms. USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 326 (2015); Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996). Although claim construction is ultimately a question of law, “subsidiary factfinding is sometimes necessary.” Teva, 574 U.S. at 326.

“It is a ‘bedrock principle' of patent law that the ‘claims of a patent define the invention to which the patentee is entitled the right to exclude.'” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (citations omitted). “The purpose of claim construction is to ‘determin[e] the meaning and scope of the patent claims asserted to be infringed.'” O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1360 (Fed. Cir. 2008) (citation omitted).

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