United States Court of Appeals 

for the Federal Circuit ______________________ 

ALLGENESIS BIOTHERAPEUTICS INC.,

Appellant

v.

CLOUDBREAK THERAPEUTICS, LLC,

Appellee

______________________ 

2022-1706

______________________ 

Appeal from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in No. IPR2020-

01438.

______________________ 

Decided: November 7, 2023

______________________ 

DONALD J. MIZERK, Husch Blackwell LLP, Chicago, IL, 

argued for appellant. Also represented by PHILIP D.

SEGREST, JR. 

 NITIKA GUPTA FIORELLA, Fish & Richardson P.C., Wilmington, DE, argued for appellee. Also represented by 

SARAH JACK, Minneapolis, MN. 

 ______________________ 

Before MOORE, Chief Judge, STOLL and CUNNINGHAM,

Circuit Judges.

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MOORE, Chief Judge. 

Allgenesis Biotherapeutics Inc. (Allgenesis) appeals 

from an inter partes review final written decision in which 

the Patent Trial and Appeal Board held that Allgenesis 

failed to prove claims 4 and 5 of U.S. Patent No. 10,149,820 

are unpatentable. Because Allgenesis has failed to establish an injury in fact sufficient to confer standing to appeal, 

we dismiss.

BACKGROUND

Cloudbreak Therapeutics, LLC (Cloudbreak) owns the 

’820 patent, which discloses compositions and methods for 

treating pterygium. ’820 patent at 1:19–22. Pterygium is

an eye condition in which a tumor-like growth extends from 

the nasal or temporal side of the eye to the cornea. Id. at 

1:26–31, 5:61–63. Historically, the only treatment option 

was surgery to remove the growth. Id. at 6:36–42. This 

surgery, however, provides no guarantee against tumor recurrence. Id. Recognizing these drawbacks, the ’820 patent sought to provide a new treatment option for 

pterygium—administering multikinase inhibitors1 to the 

eye to inhibit specific growth factors that contribute to tumor growth and hyperemia (i.e., eye redness). Id. at 6:49–

7:2, 7:19–21, 11:17–20. The patent discloses that 

nintedanib in particular “may be one of the most powerful 

multikinase inhibitors for reducing corneal neovascularization,” i.e., new blood vessel growth on the front part of 

1 The term “multikinase inhibitor” refers to “drug 

compounds (e.g., a small molecule) that reduce or inhibit 

the expression or activity of two or more kinases, including, 

for example, intracellular and/or cell surface protein kinases.” ’820 patent at 8:28–32. Examples of multikinase 

inhibitors include nintedanib, pazopanib, and sunitinib. 

Id. at 8:47–56.

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the eye that is associated with hyperemia and pterygia. Id.

at 12:3–7; see also id. at 18:2–17.

Claim 4, which depends from claims 1 and 3, is representative and recites:

1. [disclaimed] A method for reducing hyperemia 

or symptoms thereof in pterygium in an affected 

eye of a subject in need of such treatment, without 

surgically excising a pterygium, comprising administering to the affected eye of the subject a therapeutically effective amount of a multikinase 

inhibitor. 

3. [disclaimed] The method of claim 1, wherein the 

multikinase inhibitor is administered to the affected eye in the form of topical ocular formulation 

or ocular implant. 

4. The method of claim 3, wherein the multikinase 

inhibitor is nintedanib and the nintedanib is administered to the affected eye in the form of a topical ocular formulation and is administered 

topically to the affected eye. 

Id. at 24:33–37, 48–54 (emphasis added). 

Allgenesis petitioned for IPR of all eleven claims of the 

’820 patent. After the Board instituted, Cloudbreak disclaimed the genus claims, i.e., claims 1–3 and 6–11, leaving 

only claims 4 and 5, which more narrowly claim the use of 

nintedanib. 

The Board issued a final written decision holding

Allgenesis failed to show claims 4 and 5 are unpatentable. 

Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, 

LLC, No. IPR2020-01438, 2022 WL 496909 (P.T.A.B. Feb. 

15, 2022) (Decision). The Board first determined Allgenesis 

failed to show the claims were anticipated by, or would 

have been obvious over, Allgenesis’ PCT Application Publication No. WO 2016/209555 (Allgenesis’ PCT). Id. at *8–

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27. Specifically, the Board determined Allgenesis’ PCT, 

which claims priority to a U.S. provisional application filed 

June 22, 2015, does not qualify as prior art because claims 

4 and 5 may claim priority to Cloudbreak’s U.S. Provisional 

Application No. 62/172,063 (the ’063 provisional), filed 

June 6, 2015. Id. In reaching this priority determination, 

the Board found the ’063 provisional provides sufficient 

written description support for claims 4 and 5. Id. at *12–

17.

The Board also determined Allgenesis failed to show 

claims 4 and 5 would have been obvious over King2 and 

Amparo.3 Id. at *27–35. The Board determined a skilled 

artisan would have been motivated to combine the references with a reasonable expectation of success. Id. at *27–

33. But it ultimately held the claims were not unpatentable in light of objective indicia of nonobviousness, namely 

unexpected results. Id. at *33–35. The Board credited the 

’820 patent’s description of the unexpected result that 

nintedanib provides improved efficacy and has a better 

safety profile compared to the closest prior art, sunitinib. 

Id. (citing ’820 patent at Table 2, 11:17–24, 12:1–20, 18:2–

18). 

Allgenesis appeals, challenging the Board’s finding 

that the ’063 provisional provides written description support for claims 4 and 5 and its unexpected results analysis.

DISCUSSION

We have jurisdiction to review final decisions of the 

Board under 28 U.S.C. § 1295(a)(4)(A). However, Article 

2 U.S. Patent Application Publication No. 

2013/0012531.

3 Amparo et al., Safety and Efficacy of the Multitargeted Receptor Kinase Inhibitor Pazopanib in the Treatment of Corneal Neovascularization, 54 INVESTIGATIVE

OPHTHALMOLOGY & VISUAL SCI. 537–44 (2013).

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III of the U.S. Constitution limits our jurisdiction to the 

adjudication of “Cases” or “Controversies.” U.S. Const. art. 

III, § 2, cl. 1. To establish a case or controversy, a party 

invoking federal jurisdiction must meet the “irreducible 

constitutional minimum of standing.” Lujan v. Defs. of 

Wildlife, 504 U.S. 555, 560 (1992). Although a party does 

not need Article III standing to file an IPR petition or to 

obtain a Board decision, see Cuozzo Speed Techs., LLC v. 

Lee, 579 U.S. 261, 279 (2016), the party must establish Article III standing once it seeks review of the Board’s decision in this Court. Consumer Watchdog v. Wis. Alumni 

Rsch. Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014). 

To meet the Article III standing requirements, an appellant must have “(1) suffered an injury in fact, (2) that is 

fairly traceable to the challenged conduct of the defendant, 

and (3) that is likely to be redressed by a favorable judicial 

decision.” Spokeo, Inc. v. Robins, 578 U.S. 330, 338 (2016). 

To establish an injury in fact, an appellant must show it 

has “suffered ‘an invasion of a legally protected interest’ 

that is ‘concrete and particularized’ and ‘actual or imminent, not conjectural or hypothetical.’” Id. at 339 (quoting 

Lujan, 504 U.S. at 560). As the party seeking judicial review, Allgenesis bears the burden of proving it has standing. Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168, 1171 

(Fed. Cir. 2017). 

Allgenesis asserts it has standing to appeal the Board’s 

decision based on (1) its potential infringement liability 

and (2) the Board’s priority determination. We conclude 

Allgenesis has failed to meet its burden to establish standing on either ground. 

A 

Allgenesis first argues it has suffered an injury in fact 

based on the potential infringement liability stemming 

from its development of nintedanib treatments for pterygium. Where an appellant relies on potential infringement 

liability as a basis for injury in fact, “it must establish that 

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it has concrete plans for future activity that creates a substantial risk of future infringement or likely cause the patentee to assert a claim of infringement.” JTEKT Corp. v. 

GKN Auto. LTD., 898 F.3d 1217, 1221 (Fed. Cir. 2018). In 

support of standing, Allgenesis submitted a declaration 

from its Vice President of Finance, Jack Chang. J.A. 5139–

45. Mr. Chang testifies that Allgenesis has been and is 

continuing to develop formulations of nintedanib for the 

treatment of pterygium and “reasonably expects that 

Cloudbreak will seek to enforce [the ’820 patent] against 

any product brought to market.” J.A. 5144 ¶ 25; see J.A. 

5140 ¶ 5. Mr. Chang, however, fails to identify any specific, 

concrete plans for Allgenesis to develop a nintedanib product that might implicate claims 4 and 5 of the ’820 patent. 

Mr. Chang testifies that “Allgenesis is engaged in research and clinical trials” to develop its nintedanib product 

but points only to a Phase II clinical trial completed over 

three years ago and a related 2020 publication. J.A. 5140–

41 ¶ 6. He does not identify any of Allgenesis’ development 

activities since the completion of its Phase II trial in 2020

or its plans for future clinical development. For example, 

he has not identified any plans to conduct Phase III trials4

or seek FDA approval. 

4 Allgenesis asserted in its briefing and at oral argument that it plans to engage in Phase III trials. Appellant’s Opening Br. at 2; Oral Arg. at 10:08–26, available at

https://oralarguments.cafc.uscourts.gov/default.aspx?fl=22

-1706_10042023.mp3. However, there is no record support 

for this assertion, as Mr. Chang’s declaration makes no 

mention of Phase III trials. See Phigenix, 845 F.3d at 1173

(“[A]n appellant ‘must either identify . . . record evidence 

sufficient to support its standing to seek review or, if there 

is none because standing was not an issue before the 

agency, submit additional evidence to the court of appeals,’ 

such as ‘by affidavit or other evidence.’” (quoting Sierra 

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Rather, Mr. Chang generically states that “Allgenesis 

has not abandoned its development of nintedanib and is 

continuing to devote resources to the development of this 

project.” J.A. 5144 ¶ 25; see also J.A. 5141 ¶ 8 (“Allgenesis 

continues to invest in and pursue this project.”); J.A. 5144 

¶ 26 (describing Allgenesis’ past expenditures and the 

“likely” future cost of bringing the product to market); J.A. 

5145 ¶ 28 (“Allgenesis’s concrete future plans to continue 

to develop and bring to market its own nintedanib treatments for pterygium pose a substantial risk that Cloudbreak will sue Allgenesis in the future alleging 

infringement of the ’820 patent.”). Such conclusory testimony is insufficient to establish that Allgenesis has any 

concrete plans to develop and bring to market a nintedanib 

treatment for pterygium.

Beyond this, Allgenesis has not shown its activities will 

create a substantial risk of infringement or will likely 

cause Cloudbreak to assert a claim of infringement. 

Allgenesis directs us to settlement conversations between 

the parties relating to Allgenesis’ IPR petition. J.A. 5142–

44 ¶¶ 13–17, 19, 21–22, 24 (Chang Decl.). Mr. Chang explains “the parties were unable to reach a mutually agreeable settlement that could remove the likelihood of 

litigation for patent infringement when Allgenesis brings 

its product to market.” J.A. 5144 ¶ 24. These conversations merely show that Allgenesis reached out to Cloudbreak in relation to Allgenesis’ IPR petition. J.A. 5142 

¶¶ 14–15; see also Oral Arg. at 27:44–28:00. Such evidence 

is insufficient to show its activities will create a substantial 

risk of infringement, especially given that Allgenesis has 

made no assertion that Cloudbreak has sued or threatened 

to sue Allgenesis if it brings a nintedanib product to market. See AVX Corp. v. Presidio Components, Inc., 923 F.3d 

Club v. E.P.A., 292 F.3d 895, 899 (D.C. Cir. 2002)) (second 

alteration in original)).

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1357, 1365 (Fed. Cir. 2019) (“[Petitioner]’s suspicion that 

[Patent Owner] would assert the upheld claims against 

[Petitioner] if it had a reasonable basis for doing so does 

not mean that there is any reasonable basis right now.” (internal citation omitted)). 

Allgenesis has failed to establish it has nonspeculative, 

concrete plans for future activity that creates a substantial 

risk of future infringement. We therefore conclude Allgenesis has failed to show an injury in fact based on potential 

infringement liability.

B 

Allgenesis also argues it has suffered an injury in fact 

based on the Board’s priority determination. Specifically, 

the Board determined claims 4 and 5 of the ’820 patent are

entitled to the June 6, 2015 priority date of the ’063 provisional. Decision, 2022 WL 496909, at *27. Based on this, 

the Board determined Allgenesis’ PCT, which has a later 

effective filing date of June 22, 2015, is not prior art. Id. at 

*27. According to Allgenesis, because claims 4 and 5 of the 

’820 patent and Allgenesis’ PCT both relate to the same invention (i.e., nintedanib treatments for pterygium), the 

Board’s relative priority determination affects the scope 

Allgenesis’ own patent rights. 

Allgenesis asserts it suffered an injury in fact because 

the Board’s determination will have a preclusive effect on 

the scope of its pending patent application, Ser. No. 

17/750,400, which claims priority to Allgenesis’ PCT. See

Oral Arg. at 7:40–54. Allgenesis has not established that 

the Board’s decision will have preclusive effect. Again, 

Allgenesis’ allegations of harm are not sufficiently specific 

to establish any injury in fact.

We rejected a similar preclusion argument in Best Medical International, Inc. v. Elekta Inc., 46 F.4th 1346 (Fed. 

Cir. 2022). There, we held the patentee lacked standing to 

appeal a Board decision holding a claim unpatentable 

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because the patentee cancelled the claim before filing a notice of appeal. Id. at 1351–52. The patentee argued that 

certain “collateral estoppel effects” resulting from the 

Board’s decision, including that an examiner in a related 

reexamination proceeding relied on the Board’s analysis,

conferred standing. Id. at 1352. We rejected this argument, reasoning that collateral estoppel does not apply to 

non-appealable judgments and the patentee thus would be 

able to challenge the examiner’s findings and conclusions

in the reexamination proceeding on appeal. Id. at 1352–

53. We further explained, “the potential for collateral consequences is insufficient, on its own, to confer standing.” 

Id. at 1353 (internal citation and quotation marks omitted).

While Best Medical involved different facts, the reasoning is applicable here. Collateral estoppel will not attach 

to the Board’s non-appealable priority determination. See 

SkyHawke Techs., LLC v. Deca Int’l Corp., 828 F.3d 1373, 

1376 (Fed. Cir. 2016). If the examiner were to reach the 

same priority determination during prosecution of Allgenesis’ pending application, Allgenesis can challenge that determination in a separate appeal. Allgenesis has, based on 

these quite vague allegations, failed to establish a concrete 

injury.

Beyond any preclusive effect, Allgenesis argues the 

Board’s determination will still have a practical impact on 

the scope of its patent rights. Oral Arg. at 8:26–33, 8:58–

9:15. The problem with this argument is that Allgenesis 

has failed to articulate with any specificity how the Board’s 

priority determination will impact its issued patents or 

pending continuation applications which claim priority to 

its PCT application. Allgenesis’ argument on this point is 

limited to a single paragraph containing only vague allegations in its opening brief and reply brief, respectively. See

Appellant’s Opening Br. at 3–4 (“[T]he Board’s determination as to the scope of the disclosure of the ’063 provisional 

and the relative priority of the ’820 patent in comparison 

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to Allgenesis’s own patents and pending applications also 

affects or may affect . . . Allgenesis’s patent rights and the 

issued or still-pending continuation applications claiming 

priority to that application.”); Appellant’s Reply Br. at 12–

13 (“The Board’s specific priority finding, in the Final Written Decision that is the subject of this appeal, injures 

Allgenesis by impairing Allgenesis’s own patent rights.”). 

Allgenesis’ general and nonspecific allegations are insufficient to meet its burden of establishing standing. Under 

these circumstances, Allgenesis has failed to show it has 

suffered any concrete injury in fact based on the Board’s 

priority determination.

CONCLUSION

For these reasons, we conclude Allgenesis has failed to 

establish an injury in fact sufficient to confer Article III 

standing. We dismiss the appeal and do not reach the merits of the Board’s decision. 

DISMISSED

COSTS

No costs.

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