United States Court of Appeals 

for the Federal Circuit ______________________ 

LOS ANGELES BIOMEDICAL RESEARCH 

INSTITUTE AT HARBOR-UCLA MEDICAL 

CENTER,

Appellant

v.

ELI LILLY AND COMPANY,

Appellee

______________________ 

2016-1518

______________________ 

Appeal from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board, in No. IPR2014-

00752.

______________________ 

Decided: February 28, 2017

______________________ 

 EWA M. DAVISON, Fenwick & West LLP, Seattle, WA, 

argued for appellant. Also represented by DAVID KEITH

TELLEKSON, ELIZABETH B. HAGAN; VIRGINIA KAY

DEMARCHI, AMY HAYDEN, Mountain View, CA.

 MARK J. FELDSTEIN, Finnegan, Henderson, Farabow, 

Garrett & Dunner, LLP, Washington, DC, argued for 

appellee. Also represented by JOSHUA GOLDBERG, YIEYIE 

YANG; CHARLES E. LIPSEY, Reston, VA; MARK STEWART, 

Eli Lilly and Company, Indianapolis, IN.
2 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

______________________ 

Before NEWMAN, BRYSON, and MOORE, Circuit Judges.

Opinion for the court filed by Circuit Judge BRYSON. 

Opinion concurring in part, dissenting from the judgment filed by Circuit Judge NEWMAN.

BRYSON, Circuit Judge.

Appellant Los Angeles Biomedical Research Institute 

at Harbor-UCLA Medical Center (“LAB”) seeks review of 

a decision of the Patent Trial and Appeal Board holding 

all claims of U.S. Patent No. 8,133,903 (“the ’903 patent”) 

unpatentable as obvious. We vacate the Board’s order

and remand for further proceedings.

I 

A 

The ’903 patent claims a method of “arresting or regressing” a condition known as penile fibrosis. The method entails the long-term, daily administration of drugs 

known as type 5 phosphodiesterase (“PDE5”) inhibitors. 

The drugs function by inhibiting the enzymatic action of 

PDE5, which is found in the human penis. See ’903 

patent, col. 6, line 51, through col. 7, line 15.

The penis contains two cylindrical chambers called 

the corpora cavernosa. Those chambers fill with blood 

during an erection. The corpora cavernosa are surrounded by a membrane called the tunica albuginea. Penile 

fibrosis is characterized by the buildup of excess collagen. 

It includes two conditions: penile tunical fibrosis, which 

results from the buildup of excess collagen in the tunica 

albuginea, and corporal tissue fibrosis, which results from 

a buildup of excess collagen in the corpora cavernosa. See

’903 patent, col. 68, ll. 22-32, 37-39; see also id., col. 9, ll. 

45-46. 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 3

The two fibrotic conditions can cause erectile dysfunction, although they do not always do so. Tunical fibrosis 

can manifest itself as Peyronie’s disease, a condition that 

“usually leads to penile deformation (curved penis during 

erection), pain, and quite frequently erectile dysfunction.” 

’903 patent, col. 1, ll. 33-34. Corporal tissue fibrosis,

which results from the death of smooth muscle cells in the 

corpora cavernosa and a corresponding buildup of collagen, can cause dysfunction of the mechanism that retains 

blood in the corpora cavernosa during an erection. In a 

healthy male, the relaxation of the smooth muscle cells in 

the penis increases the flow of blood to the corpora cavernosa. The flow of blood into the corpora cavernosa in turn 

compresses the veins of the penis against the tunica 

albuginea to block the flow of blood from the penis. The 

compression of those veins is known as the veno-occlusive 

mechanism. Disruption of that mechanism, known as

corporal veno-occlusive disorder (“CVOD”), can lead to

erectile dysfunction. Id., col. 2, ll. 23-31. 

In addition to the two types of penile fibrosis, there

are many other causes of erectile dysfunction. Some 

causes of erectile dysfunction, such as those of psychological origin, are entirely unrelated to fibrosis.

In the early 2000s, PDE5 inhibitors such as sildenafil 

(Viagra) and tadalafil (Cialis) were well known and commonly used for the on-demand treatment of erectile 

dysfunction. See ’903 patent, col. 10, line 59, through col. 

11, line 3. The use of sildenafil and tadalafil for that 

purpose was not restricted to cases of erectile dysfunction 

resulting from penile fibrosis. Individuals with erectile 

dysfunction of varying causes were instructed to take 

PDE5 inhibitors before sexual activity in order to obtain 

an erection at the desired time. As the ’903 patent explains, that use of PDE5 inhibitors was “not addressed to 

the long-term cure of underlying tissue fibrosis.” Id., col. 

10, line 67, through col. 11, line 3. 
4 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

At that time, according to the patent, there was a 

need for adequate non-surgical treatments for Peyronie’s 

disease and other fibrotic conditions. ’903 patent, col. 2, 

ll. 2-7 (noting that surgery was “the only option” available 

in most cases of Peyronie’s disease). Erectile dysfunction 

resulting from those conditions could be treated symptomatically with on-demand PDE5 inhibitors, but there was 

“[n]o effective method of treatment . . . directed towards 

the molecular pathways underlying excessive collagen 

deposition” to address penile fibrosis. Id., col. 2, ll. 44-46. 

The ’903 patent, owned by LAB, claims such a treatment. Claim 1, the only independent claim, recites:

1. A method comprising:

a) administering a cyclic guanosine 3’, 5’-

monophosphate (cGMP) type 5 phosphodiesterase (PDE5) inhibitor according to a continuous long-term regimen 

to an individual with at least one of a 

penile tunical fibrosis and corporal tissue fibrosis; and

b) arresting or regressing the at least one 

of the penile tunical fibrosis and corporal tissue fibrosis, wherein the PDE5 inhibitor is administered at a dosage 

up to 1.5 mg/kg/day for not less than 45 

days.

’903 patent, col. 68, ll. 23-32. 

The remaining four claims depend from claim 1 and 

concern the type of drug (claim 2), the type of fibrotic 

condition (claim 3), the mode of administration (claim 4), 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 5

and the duration of treatment (claim 5). Id., col. 68, ll. 33-

45.1

B 

In 2013, LAB filed an infringement action in the 

United States District Court for the Central District of 

California against Eli Lilly & Company (“Lilly”), alleging 

that Lilly’s marketing of the drug Cialis induced infringement of the ’903 patent. Los Angeles Biomed. 

Research Inst. v. Eli Lilly & Co., No. 2:13-cv-08567-JAKJCG (C.D. Cal. filed Nov. 20, 2013). Lilly subsequently 

filed multiple petitions requesting that the Patent Trial 

and Appeal Board conduct inter partes review of the ’903 

patent. The Board instituted inter partes review on the

petition in which Lilly contended that all the claims of the 

’903 patent were unpatentable as obvious in light of three 

references. The cited references were: Francesco Montorsi 

et al., The Ageing Male and Erectile Dysfunction, 20 

World J. Urology 28-53 (2002) (“Montorsi”); International 

Patent Application No. WO 01/80860 (published Nov. 1, 

2001) (John S. Whitaker et al., applicants) (“Whitaker”); 

and Hartmut Porst et al., Daily IC351 Treatment of ED, 

12 Int’l J. Impotence Research (Supp. 3) S76, B13 (2000) 

(“Porst”).2

1 LAB has not presented separate arguments for 

the patentability of any of the dependent claims.

2 The Board also instituted inter partes review on 

the petition in which Lilly argued that all the claims of 

the ’903 patent were unpatentable as anticipated by 

Whitaker. The Board conducted that inter partes review 

in a separate proceeding, No. IPR2014-00693. At the 

conclusion of that proceeding, the Board ruled that the 

claims were not anticipated. That decision, which Lilly 

appealed, is addressed in the related case, Eli Lilly & 

Company v. Los Angeles Biomedical Research Institute at 

 
6 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

The ’903 patent claims priority from Provisional Application No. 60/420,281, which was filed on October 22, 

2002. ’903 patent, col. 1, ll. 12-15. The Board rejected 

LAB’s argument for the earlier priority date and determined that the specification of the provisional application 

did not disclose the dosage limitation of “up to 1.5 

mg/kg/day,” i.e., a dosage of up to 1.5 milligrams of PDE5 

inhibitor per kilogram of the patient’s body weight each 

day.

The Board also construed several claim limitations 

that are now at issue on appeal. First, the Board construed the phrase “an individual with at least one of 

penile tunical fibrosis and corporal tissue fibrosis” to 

mean an “individual hav[ing] symptoms that may be 

associated with penile fibrosis, such as [erectile dysfunction], but not that the patient be specifically diagnosed as 

having penile tunical fibrosis or corporal tissue fibrosis.” 

Second, the Board construed the phrase “arresting or 

regressing the at least one of the penile tunical fibrosis 

and corporal tissue fibrosis” as having no limiting role, 

but merely stating the intended result of administering a 

PDE5 inhibitor at a dosage of up to 1.5 mg/kg/day for at 

least 45 days. 

Third, in the Decision on Institution, the Board construed the term “continuous long-term regimen” to mean 

“the administration of drug over a certain period of time 

without intermission such that the treatment is therapeutically effective.” In its final decision, the Board concluded that the claim limitation requiring the delivery of a 

dosage of up to 1.5 mg/kg/day for at least 45 days “would 

meet the claim requirement of a continuous, long-term 

regimen.”

Harbor-UCLA Medical Center, No. 2016-1547, decided 

together with this case but in a separate opinion. 

 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 7

The Board then addressed the three prior art references: Montorsi, Whitaker, and Porst. 

Montorsi is a review article that addresses the treatment of erectile dysfunction in the aging male population. 

Montorsi states that male erectile dysfunction is associated with aging; that atherosclerosis (the buildup of plaque 

in the arteries) is common in the elderly; and that atherosclerosis is associated with CVOD and corporal fibrosis, 

which can cause erectile dysfunction. Montorsi at 28, 30-

31. Montorsi concludes that “it seems reasonable to 

hypothesise that the [erectile dysfunction] from ageing is 

the result of atherosclerosis-induced cavernosal ischaemia 

leading to cavernosal fibrosis and [CVOD].” Id. at 31. 

Montorsi discusses several relevant studies of erectile 

dysfunction. It begins by reviewing a group of studies on 

sildenafil as a treatment for erectile dysfunction in elderly 

patients. The patients in that study were instructed to 

take up to 100 mg of sildenafil on demand (one hour 

before sexual activity) but no more than once daily over a 

12 week to 6 month period. Those studies showed that 

sildenafil was well tolerated and that it ameliorated the 

treated condition. Montorsi at 32-33. Another study 

reported that administering a 100 mg dose of sildenafil at 

bedtime to male patients between 40 and 68 years old 

with erectile dysfunction produced an increase in nocturnal erections. Id. at 31 (citing Francesco Montorsi et al., 

Sildenafil Taken at Bedtime Significantly Increases 

Nocturnal Erections: Results of a Placebo-Controlled 

Study, 56 Urology 906, 907 (2000)). Montorsi concludes 

that this study “opened the door to further study investigating the possible dosage of sildenafil to be administered 

daily at bedtime to prevent or treat [erectile dysfunction] 

in the elderly patient.” Montorsi at 31. 

Whitaker is an abandoned patent application that 

claims the chronic use of low-dose PDE5 inhibitors to 

treat erectile dysfunction. Whitaker defines “chronic” as 
8 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

“the regular administration of the [PDE5 inhibitor] in 

intervals unrelated to the onset of sexual activity,” and 

states that “chronic administration generally refers to 

regular administration for an extended period, preferably 

daily for three or more days, and still more preferably 

daily for as long as the patient suffers from erectile dysfunction (in the absence of therapy).” Whitaker at 7. 

Whitaker defines “daily” as “administration of the [PDE5 

inhibitor] one or more times, generally one to three times, 

still more preferably one time, per about 24-hour period.” 

Id.

Example 6 of Whitaker combines data from five clinical studies to show that chronic administration of low 

doses (5 mg or 10 mg) of tadalafil improved erectile function in a population of patients with male erectile dysfunction. Whitaker at 34. The study population included 

four subgroups, in which tadalafil was taken (1) less than 

30% of the time, (2) 30-50% of the time, (3) 50-70% of the 

time, and (4) more than 70% of the time. Id. Example 6 

states that tadalafil “was administered ‘daily’ to [these] 

patients.” Id.; accord id. at 35 (“The Study Drug was 

administered in 5 mg and 10 mg doses, ‘daily’ and not 

more than once every 24 hours.”). Whitaker notes “a 

trend toward better response with increased frequency of 

dose.” Id. at 36 (referring to results showing better erectile function in subgroups 3 and 4 than in subgroups 1 

and 2). In Example 7, tadalafil was administered daily 

for three weeks to men 21-72 years old with erectile 

dysfunction, in subgroups receiving either a placebo or 

one of four dosages (10, 25, 50, and 100 mg). The results 

showed that “[a]dverse events [side effects] were doserelated, and attenuated with continued daily treatment.” 

Id. at 38.

Whitaker states that “[t]he enhanced efficacy demonstrated by low daily dosing of a PDE5 inhibitor in treating 

erectile dysfunction . . . results from improved vascular 

responsiveness when the PDE5 inhibitor is present con-
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 9

tinuously, or essentially continuously, in plasma.” Whitaker at 12. Whitaker terms that effect “vascular conditioning,” an effect that had not been reported or observed 

in treatments with PDE inhibitors generally, nor more 

specifically in the case of on-demand dosing of PDE5 

inhibitors. Id. Whitaker concludes that “[i]t is expected 

that vascular conditioning occurs after chronic administration of the PDE5 inhibitor, for example, after about 

three daily doses of up to 10 mg, preferably after five days 

of daily dosing, and more preferably after seven days of 

daily dosing. In addition, after about three days of daily 

dosing, intermittently missing one chronic dose may lead 

to a reduction in vascular conditioning, but not a complete 

loss of conditioning.” Id. at 13. Whitaker then posits: “It 

is theorized, but not relied upon herein, that vascular 

conditioning is caused by a partial or complete reversal of 

circulatory dysfunctions in penile circulation arising from 

conditions such as diabetes, atherosclerosis, smoking, 

hypertension, or a combination of such factors.” Id. at 13. 

Porst is a published abstract of a study showing that 

100 mg of tadalafil administered daily for three weeks to 

men with erectile dysfunction having a mean age of 52.4 

years was safe and well tolerated, and that it improved 

erectile function. 

The Board found that Montorsi and Whitaker taught

administering a PDE5 inhibitor to an individual with 

erectile dysfunction, as required by its construction of “an 

individual with at least one of a penile tunical fibrosis and 

corporal tissue fibrosis.” The Board also found that 

Montorsi taught that erectile dysfunction in the aging 

male is associated with atherosclerosis, which in turn is 

associated with the development of corporal fibrosis, and 

that Whitaker taught that long-term treatment with a 

PDE5 inhibitor can cause reversal of circulatory dysfunctions caused by diabetes, atherosclerosis, smoking, hypertension, or a combination of such factors.
10 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

The Board further found that the three references together taught daily dosing of up to 1.5 mg/kg/day for at 

least 45 days, and therefore met the “continuous longterm regimen” limitation of the ’903 patent. In particular, 

the Board found that Montorsi taught dosing of up to 100 

mg of sildenafil per day. According to the ’903 patent, col. 

45, ll. 7-12, a dosage of 100 mg per day is roughly equivalent to 1.5 mg/kg for an average weight adult male. 

Although the Board acknowledged that Whitaker’s Example 6 did not specifically disclose dosing every day, it 

noted that Whitaker taught that better results are obtained with increased frequency of dosing, that adverse 

effects are attenuated with daily administration, and that 

treatment should continue for as long as the erectile 

dysfunction persists. Finally, the Board found that Porst 

taught that a dosage of 100 mg of tadalafil per day is safe 

and well tolerated. 

In response to Lilly’s arguments based on the prior 

art references, LAB argued that its treatment method 

produced unexpected results, because at the time of the 

invention the scientific community believed that PDE5 

inhibitors would exacerbate fibrosis, not treat it. That 

belief, according to LAB, was based on the understanding 

that the enzyme inductible nitric oxide synthase (“iNOS”) 

and its product, nitric oxide, which have a mechanism of 

action similar to that of PDE5 inhibitors, were profibrotic. 

The Board rejected that argument on the ground that the 

claims of the ’903 patent do not require a particular 

mechanism of action and that any antifibrotic effect 

resulting from the administration of PDE5 inhibitors, 

whether expected or not, is inherent. 

The Board ultimately concluded that the combination 

of references satisfies each of the limitations of the ’903 

patent, as construed, and that the combination provides a 

reasonable expectation of success in treating erectile 

dysfunction.
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 11

On appeal, LAB argues that the Board erred (1) in 

denying LAB’s claim of priority to the October 2002 filing 

date of the inventors’ provisional application, (2) in construing the three disputed claim terms, (3) in deciding 

that claim 1 of the ’903 patent would have been obvious 

based on incorrect claim constructions, and (4) by failing 

to adequately consider the prevailing beliefs in the field 

and the unexpected results achieved by the inventors. 

II

A 

In order for a patent to be entitled to priority based on 

an earlier application or chain of applications, each previous application in the chain must comply with the written 

description requirement of 35 U.S.C. § 112(a). Bradford 

Co. v. Conteyor N. Am., Inc., 603 F.3d 1262, 1269 (Fed. 

Cir. 2010). To satisfy the written description requirement, the disclosure in each application must “reasonably 

convey[]” to those skilled in the art that as of the claimed 

priority date the inventor was in possession of the later 

claimed subject matter. Vas-Cath Inc. v. Mahurkar, 935 

F.2d 1555, 1563 (Fed. Cir. 1991). A disclosure in a parent 

application is not sufficient if it “merely renders the laterclaimed invention obvious . . . ; the disclosure must describe the claimed invention with all its limitations.” 

Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158 (Fed. Cir. 

1998). 

In this case, the inventors filed a provisional application in October 2002 to which the ’903 patent claims 

priority. Lilly argues on appeal that the three prior art 

references were published before the provisional application was filed and are thus prior art under 35 U.S.C. § 

102(a) even with the priority date of October 2002. LAB 

responds that Lilly asserted Whitaker and Montorsi as 

prior art only under 35 U.S.C. § 102(b) before the Board 

and that Whitaker and Montorsi do not qualify as prior 

art under that provision. We decline to address the 
12 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

question of Lilly’s waiver, as we conclude on the merits

that the ’903 patent is not entitled to the priority date of 

the provisional application because of a lack of adequate 

written description. 

The provisional application does not explicitly disclose 

a dosage of “up to 1.5 mg/kg/day.” LAB, however, contends that the dosage level is disclosed by a rat study 

described in the provisional application. In that study, 

rats were provided with 100 mg/L (milligrams per liter) of 

sildenafil in drinking water. LAB argues that a person of 

skill in the art would be able to calculate the corresponding human dosage according to a conversion method

devised by E. J. Freireich, and that the result of that 

computation would be a dosage of approximately 1.5 

mg/kg/day. See Emil J. Freireich, Quantitative Comparison of Toxicity of Anticancer Agents in Mouse, Rat, Hamster, Dog, Monkey, and Man, 50 Cancer Chemotherapy

Reports 219-44 (1966).

LAB’s argument depends on several assumptions regarding the knowledge of a person of skill in the art. 

Such a person would have to know the average daily 

water intake of the rat model used in the ’903 patent, the 

average weight of the rat model used in the ’903 patent, 

the average weight of an adult human male, and the 

average height of an adult human male. Moreover, that

person would need to know of the Freireich method for 

calculating the rat-to-human interspecies dosage conversion and have a reason to apply it. The Board held that 

the first four variables were not knowable from the disclosure in the application, but would at best require persons 

of skill to look to the prior art and make assumptions. 

That is not enough to establish priority. See Lockwood v. 

Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) 

(“It is not sufficient for purposes of the written description 

requirement of § 112 that the disclosure, when combined 

with knowledge in the art, would lead one to speculate as 

to modifications that the inventor might have envisioned, 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 13

but failed to disclose.”). Moreover, the underlying assumptions for LAB’s expert’s derivation were themselves 

faulty. For example, LAB’s expert assumed an adult male

weight of 86.1 kg to calculate the 1.5 mg/kg/day human 

dosage from the rat study. He relied on an uncited, nonprior art reference for that data. Lilly’s expert showed 

that the dosage would have been approximately 1.7 

mg/kg/day if 67 kg—the weight disclosed in the ’903 

patent—had been used instead.3 

As for the fifth assumption, LAB presented no evidence as to why a person of skill would choose to rely on 

the Freireich method to calculate a human dosage for 

therapeutic treatment of fibrosis with PDE5 inhibitors. 

That reference was not disclosed in the provisional application, is nearly half a century old, and was based on 

measurements of toxicity of anticancer agents. More 

importantly, LAB cannot rely on standalone references 

that it failed to incorporate in the provisional application 

in order to make out its priority claim. “[I]t is the disclosures of the [provisional] application[] that count,” not 

those of uncited references. Allergan, Inc. v. Sandoz Inc., 

796 F.3d 1293, 1309 (Fed. Cir. 2015) (holding that it was 

error to rely on a clinical protocol to show earlier possession because the protocol was not disclosed in the specifications of the asserted patents). 

Because proof of priority requires written description 

disclosure in the parent application, not simply information and inferences drawn from uncited references, the 

Board correctly held that LAB’s expert’s calculation did

not satisfy the requirements for priority and that the ’903 

3 The patent states that “1.5 mg/kg . . . is about the 

dose ingested by men with an on demand single 100 mg 

tablet.” ’903 patent, col. 45, ll. 7-12. That passage assumes that an adult man weighs approximately 67 kg.

 
14 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

patent was therefore not entitled to the October 2002 

priority date of the provisional application. 

B 

In an inter partes review proceeding, the Board gives 

claims their broadest reasonable interpretation consistent 

with the specification. In re Cuozzo Speed Techs., LLC, 

793 F.3d 1268, 1276, 1279 (Fed. Cir. 2015), aff’d, 136 S. 

Ct. 2131, 2142 (2016). We review the Board’s claim 

construction de novo except for subsidiary fact findings, 

which we review for substantial evidence. Id. at 1280.

1. The broadest reasonable interpretation of the 

phrase “an individual with at least one of penile tunical 

fibrosis and corporal tissue fibrosis” is its plain meaning: 

an individual with penile tunical fibrosis and/or corporal 

tissue fibrosis.4 The Board’s construction (“an individual 

hav[ing] symptoms that may be associated with penile 

fibrosis, such as [erectile dysfunction], but not that the 

patient be specifically diagnosed as having penile tunical 

fibrosis or corporal tissue fibrosis”) reads that limitation 

out of the claim. That is because erectile dysfunction can 

have causes other than penile fibrosis, and because penile 

fibrosis does not necessarily result in erectile dysfunction. 

Because erectile dysfunction is merely a symptom that 

4 Although Lilly claims that any “plain meaning” 

argument was waived below, LAB adequately preserved 

that argument when it stated in its Response to the 

Petition for Institution that “a person of ordinary skill in 

the art would understand the claims of the ’903 patent to 

concern treatment of fibrosis, a disease.” See Phillips v. 

AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en 

banc) (“[T]he ordinary and customary meaning of a claim 

term is the meaning that the term would have to a person 

of ordinary skill in the art in question at the time of the 

invention.”).

 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 15

may be, but is not necessarily, associated with penile 

fibrosis, erectile dysfunction cannot be equated with

tunical fibrosis and corporal tissue fibrosis. 

The patent makes clear that penile fibrosis and erectile dysfunction are not the same thing and do not necessarily accompany one another. The specification makes 

clear that penile fibrosis may result in erectile dysfunction, but it may not. E.g., ’903 patent, col. 1, ll. 29-34, 43-

44 (“Peyronie’s disease is a fibromatosis of the tunica 

albuginea” that “[c]linically . . . quite frequently leads to 

erectile dysfunction” but “is not always associated with 

erectile dysfunction”). Conversely, the specification 

acknowledges that erectile dysfunction has alternative 

causes and may present without underlying penile fibrosis. See, e.g., id., col. 2, ll. 23-26 (“aging associated [erectile dysfunction] . . . is mostly related to the loss of 

[smooth muscle cells] in the penile corpora cavernosa by 

apoptosis [cell death], with a corresponding increase in 

collagen fibers”); id., col. 2, ll. 28-31 (“clinical result of this 

aging process in the penis is defective cavernosal [smooth 

muscle cell] relaxation leading to [CVOD], the most 

common cause of [erectile dysfunction]” in aging males). 

The patented invention targets the treatment of fibrosis, whether or not the fibrosis causes erectile dysfunction

in a particular case. For example, the invention treats

Peyronie’s disease even in a patient with no symptoms of 

erectile dysfunction. The point is that the claimed treatment method is intended to decrease the level of fibrotic 

tissue, without regard to whether the patient’s fibrosis is 

accompanied by erectile dysfunction. 

The Board relied on a statement in the Background 

section of the patent that notes that “[a] need exists for 

effective methods to treat and/or ameliorate the symptoms of a variety of fibrotic disease, such as [Peyronie’s 

disease], [erectile dysfunction] and arteriosclerosis.” ’903 

patent, col. 2, ll. 42-44. But that statement plainly refers 
16 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

to instances of erectile dysfunction that arise from fibrosis 

(a “symptom[] of . . . fibrotic disease”), not to all cases of 

erectile dysfunction. The next sentence in the specification clarifies that the focus of the treatment method is 

fibrosis, not the possible symptoms of fibrosis, such as 

erectile dysfunction. That sentence states: “No effective 

method of treatment currently exists that is directed 

towards the molecular pathways underlying excessive 

collagen deposition [fibrosis].” Id., col. 2, ll. 44-46. 

This court’s decision in Rapoport v. Dement, 254 F.3d 

1053 (Fed. Cir. 2001), is closely analogous to this case. 

There, the appellant argued that the claim term “treatment of sleep apneas” encompassed treatment of the 

symptoms associated with sleep apnea. Id. at 1059. This 

court disagreed, noting that the plain meaning of the term 

sleep apnea and the specification made clear that the 

patent was directed to treatment of the underlying sleep 

apnea condition, even though the written description 

noted that the claimed “treatment [also] alleviates the 

sleep apnea-related symptoms of anxiety, depression, 

fatigue, malaise, irritability, anger and hostility.” Id.

(citing patent application).

In this case, similarly, the ’903 specification mentions 

various fibrotic conditions and their possible symptoms. 

See, e.g., ’903 patent, col. 2, ll. 13-22 (arteriosclerosis, or 

fibrosis of the media of the arterial wall, is one of the 

underlying causes of hypertension). But the claims are 

narrower and are clearly aimed at penile fibrosis—not 

other types of fibrosis, and not at symptoms such as

erectile dysfunction. See Rapoport, 254 F.3d at 1059 

(“[t]he plain language . . . unambiguously refers to ‘treatment of sleep apneas’ narrowly defined, and does not also 

include by its plain terms ‘treatment of symptoms associated with sleep apneas.’”). The specification’s references 

to erectile dysfunction as a possible symptom of penile 

fibrosis do not broaden the phrase “an individual with at 

least one of penile tunical fibrosis and corporal tissue 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 17

fibrosis” beyond its ordinary meaning. As in Rapoport, 

the ordinary meaning “narrowly refers to . . . the underlying disorder itself.” Id. 

The Board’s construction would make the patent 

claims applicable to individuals with erectile dysfunction 

not caused by penile fibrosis. Yet for patients suffering 

from erectile dysfunction without penile fibrosis, the 

claimed method would have no effect on the treatment of 

penile fibrosis. The Board’s construction is therefore not 

the broadest reasonable interpretation of the disputed 

claim language; rather, it is overly broad. Given the 

relationship between erectile dysfunction and penile 

fibrosis, it is unreasonable to use the symptom of erectile 

dysfunction as a proxy for penile fibrosis.

On the other hand, there is no support in the patent 

or the prosecution history for LAB’s contention that the 

phrase “an individual with at least one of penile tunical 

fibrosis and corporal tissue fibrosis” requires an individual to have “clinically significant” penile tunical or corporal 

tissue fibrosis. Both parties’ experts agreed that some

physicians would treat fibrosis even if it was not deemed 

“clinically significant.” We see no reason to import such a 

limitation here, and we conclude that “an individual with 

at least one of penile tunical fibrosis and corporal tissue 

fibrosis” includes an individual with one or both of those 

conditions, even if the condition is not deemed “clinically 

significant.” 

2. The limitation “arresting or regressing the at least 

one of the penile tunical fibrosis and corporal tissue 

fibrosis” requires halting the progression of, or reversing, 

penile fibrosis. Lilly contends that the phrase “arresting 

or regressing the [penile fibrosis]” has no patentable 

weight. We conclude, however, that the phrase is more 

than a statement of the intended result of administering 

the PDE5 inhibitor within the dosage limits, with the 
18 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

frequency, and for at least the minimum period prescribed 

in the patent.

The full text of the limitation in which the “arresting 

or regressing” language appears reads: “arresting or 

regressing the [penile] fibrosis, wherein the PDE-5 inhibitor is administered at a dosage up to 1.5 mg/kg/day for not 

less than 45 days.” ’903 patent, col. 68, ll. 29-32. While 

not dispositive, it is significant that the phrase “arresting 

or regressing the [penile] fibrosis” is drafted as part of a 

separate step of the method, not as the preamble or 

introduction to a process carried out by the administration of the drug. The structure of the ’903 patent claim 1 

is therefore not comparable to the structure of patent

claims in which statements of general purpose in the

preambles of method claims have been held to carry no 

patentable weight. E.g., Bristol-Myers Squibb Co. v. Ben 

Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001)

(preamble phrase “for reducing hematologic toxicity” was 

“non-limiting, and merely expressing a purpose”); see also

In re Montgomery, 677 F.3d 1375, 1380 (Fed. Cir. 2012)

(expressing “skeptic[ism]” that the phrase “for the treatment or prevention of stroke” in a claim preamble was 

more than an expression of purpose for the claimed method).

Other intrinsic evidence shows that the “arresting or 

regressing” limitation does not merely duplicate the 

wherein clause that follows. “Arresting or regressing”

demands efficacy; the wherein clause does not. As explained in the specification, “arresting” means “halt[ing] 

the progression” or “prevent[ing] the further development” of the fibrotic condition, and “regressing” means 

“reduc[ing] in size” or “reversing” the fibrotic condition. 

’903 patent, col. 3, ll. 8-13; id., col. 9, ll. 13-15; see also id., 

col. 2, ll. 53-61. In Example 3 of the specification, the 

inventors demonstrated the arrest or regression of fibrosis 

when administering a PDE5 inhibitor to rats daily for 45 

days at a dosage equivalent to 1.5 mg/kg/day for an adult 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 19

human male. ’903 patent, col. 36, line 25, through col. 37, 

line 5 (Example 3); id., col. 45, ll. 7-12.

The wherein clause sets forth the minimum duration 

supported by the disclosure (45 days) for the arrest or 

regression of fibrosis at a high dosage of the PDE-5 inhibitor. But the reference to a minimum duration period of 45 

days says nothing about the efficacy of the method if a

lower dosage of PDE5 inhibitor is administered. As the 

inventors explained during prosecution, “it is likely that if 

the dose [administered to the rats in Example 3] is reduced to 1/2 of the current dose to adapt it to the clinic 

and minimize side effects, the duration of the antifibrotic 

treatment may take 2 to 6 months or longer.”5 

Because the ’903 patent claims specify only a maximum dosage level and a minimum treatment period, it is 

different from cases in which the claims contain express 

dosage amounts as material claim limitations, and in 

which efficacy is “inherent in carrying out the claim 

steps.” Dawson v. Dawson, 710 F.3d 1347, 1355 (Fed. Cir. 

2013) (citing Bristol-Myers Squibb, 246 F.3d at 1375, and 

In re Montgomery, 677 F.3d at 1381). We therefore conclude that “arresting or regressing” the fibrosis adds an 

efficacy requirement that is not otherwise found in the 

claim language. 

Nor do LAB’s infringement contentions in the ongoing 

district court case render the “arresting or regressing” 

5 The inventors also stated during prosecution that, 

“like in the aging rat model [Example 3], it takes at least 

45 days of treatment with sildenafil to ameliorate the 

CVOD and underlying corporal fibrosis,” which “was done 

with daily doses equivalent to 2.5 fold the doses currently 

applied in the clinic to elicit an erection.”

 
20 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

limitation irrelevant.6 LAB alleged that the “[l]ong-term 

administration of Cialis on a once daily basis for the 

treatment of [erectile dysfunction] results in the arrest or 

regression of penile tunical fibrosis (i.e., [Peyronie’s 

disease]) and corporal tissue fibrosis (i.e., [CVOD]).” 

[LAB]’s Disclosure of Asserted Claims and Preliminary 

Infringement Contentions, Ex. A at 5, Los Angeles Biomed. Research Inst. v. Eli Lilly & Co., No. 2:13-cv-08567-

JAK-JCG (C.D. Cal. filed May 19, 2014). But LAB did not 

define “long-term” in that context. In order to prove 

infringement, LAB may need to show, for example, that 

Lilly induces the administration of 2.5 mg or 5 mg of 

Cialis daily by patients with penile tunical or corporal 

tissue fibrosis for a period of time that is long enough, 

given the dosage levels, to result in the arrest or regression of fibrosis. In any event, LAB does not contend that 

the Cialis label induces infringement by instructing the 

daily administration of 2.5 mg or 5 mg of Cialis, regardless of the duration of the treatment.

3. Claim 1 of the ’903 patent contains a limitation 

providing for a “continuous long-term regimen” in addition to the limitation providing for administering a PDE5 

inhibitor in an amount “up to 1.5 mg/kg/day for not less 

than 45 days.” The 45-day requirement makes clear that 

the “continuous long-term regimen” must be at least 45 

days in length. 

6 We deny LAB’s motion to strike Lilly’s references 

to those filings. We can properly take judicial notice of 

the records of related court proceedings. See Function 

Media, L.L.C. v. Google, Inc., 708 F.3d 1310, 1316 n.4 

(Fed. Cir. 2013). Because we take judicial notice of those 

records, we do not reach Lilly’s conditional objection to 

LAB’s reliance on the Final Written Decision in the 

related IPR proceeding on anticipation. See note 2 supra. 

 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 21

LAB argues that the term “continuous long-term regimen” adds a requirement that the drug concentration in 

the patient’s body attain a “constant level,” i.e., maintain 

a “steady state” plasma concentration. The patent, however, never mentions the “steady state” of a drug or other 

agent. As for “constant level,” LAB points to a single

sentence buried in the middle of the 68-column disclosure 

that states: 

A distinction exists between long-term (weeks, 

months, years) continuous treatment with, for example, a PDE5 inhibitor such as sildenafil to 

maintain a constant level of these agents in order 

to arrest or regress a fibrotic condition, versus on 

demand (prior to the sexual act) single pill, shortterm treatment with sildenafil or other PDE5 inhibitors to obtain smooth muscle vasodilation in

the penis (male penile erection) or vagina/clitoris 

(female sexual arousal) upon sexual stimulation.

’903 patent, col. 10, ll. 59-67. In that passage, the term

“constant level” is not presented as a definition of “continuous long-term regimen,” or its equivalent. Rather, the 

passage simply confirms that long-term continuous PDE5 

inhibitor treatment excludes an “on demand . . . single 

pill, short-term treatment”; the passage does not exclude 

any treatment that fails to maintain an unvarying level of 

the drug within the patient’s body. 

Nor is “a constant level” required by anything else in 

the specification. If an applicant intends to ascribe a 

meaning to a claim term different from its ordinary 

meaning, he must “set out the different meaning in the 

specification in a manner sufficient to give one of ordinary 

skill in the art notice of the change from ordinary meaning.” Innova/Pure Water, Inc. v. Safari Water Filtration 

Sys., Inc., 381 F.3d 1111, 1117 (Fed. Cir. 2004). Because 

the patentees in this case have not “demonstrated a clear 

intention to limit the claim scope,” id., in a manner incon-
22 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

sistent with the ordinary meaning of the term “continuous,” it would be improper to construe the claim language 

in the manner that LAB suggests.

Although LAB argues that the term “continuous longterm regimen” should be construed to require a “constant 

level of the administered PDE-5 inhibitor,” the position 

LAB took before the Board and takes in its briefs before 

this court makes clear that LAB is not using the word 

“constant” in its conventional sense. In its opening brief, 

LAB argues that a “constant level” of a PDE5 inhibitor 

refers to “the average plasma concentration of that drug 

upon reaching steady state,” even though the actual 

concentration “peaks and then declines.” LAB Opening 

Br. 36. In its reply brief, LAB departs even farther from 

the ordinary meaning of “constant” and argues that “a 

meaningful steady state (‘constant level’) requires a dose 

interval that allows drug concentration to stay within its 

therapeutic range.” LAB Reply Br. 16. 

LAB cites its expert’s report and a pharmacology text 

to support its argument that frequent dosages of a drug 

with a short half-life are required to maintain a high, if 

varying, level of plasma drug concentration. However,

LAB points to nothing in the patent that supports the 

construction of the term “continuous long-term regimen” 

to require dosing frequency sufficient to maintain the 

level of drug concentration within what LAB refers to as 

“its therapeutic range.” 

The prosecution history also undercuts LAB’s argument. In the provisional application, claim 16 required 

both a “continuous long term regimen” and “maintaining 

a constant level.” It provided: “The method of claim 1, 

wherein said administering comprises long term continuous treatment for weeks, months or years to maintain a 

constant level of the inhibitor.” But in the 2004 application that matured into the ’903 patent, the claims did not 

include the language “maintaining a constant level.” The 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 23

separate use of those terms in the provisional application

gives rise to the inference that “maintaining a constant 

level” is not implicit in the term “continuous long-term 

regimen.” And the omission of the reference to “maintaining a constant level” from the non-provisional application 

strongly suggests that the claims in the patent were not 

meant to require that a constant level of the PDE5 inhibitor be maintained.

LAB points out that during prosecution the inventors 

distinguished “continuous long-term” treatment from ondemand treatment. While that is true, the inventors drew 

that distinction based on the duration of the treatment 

regimen, not on the plasma level of the drug. For example, in addressing the prior art, the inventors “predict[ed] 

that 21 days of even a daily or twice a day treatment with 

a PDE5 inhibitor would be totally insufficient . . . to 

prevent or ameliorate CVOD, since in our unpublished 

study on the time course of CVOD in the rat after cavernosal nerve damage, . . . once CVOD is established, . . . it 

takes at least 45 days of treatment with sildenafil to 

ameliorate CVOD and underlying corporal fibrosis.” 

There is no suggestion in the prosecution history that a 

“constant level” of the drug is required for patentability or 

efficacy.

Finally, LAB argues that the Board’s construction impermissibly renders the term “continuous long-term 

regimen” superfluous in light of the limitation requiring 

administration of the PDE5 inhibitor “at a dosage up to 

1.5 mg/kg/day for not less than 45 days.” While the two 

limitations clearly overlap, the more general reference to 

a “continuous long-term regimen” limitation serves to 

emphasize that the treatment is continuous and not 

sporadic. The fact that the limitations overlap is not 

fatal, nor does it compel us to adopt an otherwise unsupported construction of the claims. See SimpleAir, Inc. v. 

Sony Ericsson Mobile Commc’ns AB, 820 F.3d 419, 429 

(Fed. Cir. 2016) (Although “interpretations that render 
24 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

some portion of the claim language superfluous are disfavored,” that “preference for giving meaning to all 

terms . . . is not an inflexible rule that supersedes all 

other principles of claim construction.”). The overlap in 

the limitations that results from giving them their plain 

meaning does not justify importing a “constant level” or 

“steady state” limitation into the claims where such a 

limitation has no support in the specification or the 

prosecution history. 

C 

Determining whether an invention would have been 

obvious requires consideration of the scope and content of 

the prior art, differences between the prior art and the

patent claims, the level of ordinary skill in the art, and 

any secondary considerations. KSR Int’l Co. v. Teleflex 

Inc., 550 U.S. 398, 406 (2007). In the case of a combination of references that together disclose all the limitations

of the claimed invention, the adjudicator must determine 

whether there was an “apparent reason to combine the 

known elements in the fashion claimed by the patent at 

issue,” id. at 418, and whether a person of skill in the art

at the time of the invention would have had a “reasonable 

expectation of success” in pursuing that combination, see 

Genzyme Therapeutic Prods. Ltd. P’ship v. Biomarin 

Pharm. Inc., 825 F.3d 1360, 1373 (Fed. Cir. 2016). 

LAB contends that the Board’s findings are insufficient to establish obviousness under the correct constructions of “an individual with at least one of a penile tunical 

fibrosis and corporal tissue fibrosis” and “arresting or 

regressing the at least one of a penile tunical fibrosis and 

corporal tissue fibrosis.” We agree. The Board concluded 

that the references on which it relied rendered obvious 

the treatment of erectile dysfunction via the claimed 

method, but it did not determine whether those references 

showed that it would have been obvious to use long-term 

continuous treatment with a PDE5 inhibitor to treat 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 25

individuals with penile fibrosis and to achieve the arrest 

or regression of that condition. 

1. The Board found that Montorsi and Whitaker 

taught the treatment of erectile dysfunction, a symptom 

sometimes associated with penile fibrosis, and that the 

combination of Montorsi, Whitaker, and Porst gave rise to

a reasonable expectation of success in treating erectile 

dysfunction. What the Board did not do, however, was to 

find that those references taught treating a patient with 

penile tunical fibrosis or corporal tissue fibrosis. Nor did 

the Board find that those references provided the basis for

a reasonable expectation of success in treating those 

conditions. See Institut Pasteur & Universite Pierre et 

Marie Curie v. Focarino, 738 F.3d 1337, 1346 (Fed. Cir. 

2013) (“Importantly, without a sound explanation for 

doing otherwise, . . . the expectation-of-success analysis 

must match the highly desired goal, not switch to a different goal that may be a less challenging but also less 

worthwhile pursuit.”). As indicated above, the correct 

construction of the pertinent claim language requires 

more than simply treating erectile dysfunction.7 

To be sure, Montorsi teaches that corporal fibrosis is 

associated with erectile dysfunction in atherosclerotic or 

aging patient populations. Montorsi, however, is directed 

7 The dissent states that the Board found that the 

method of claim 1 was used in the prior art. The Board’s 

findings, however, rest on its erroneous claim constructions, including equating erectile dysfunction with penile 

fibrosis. The Board found in the prior art the method of 

long-term administration (i) to an individual with erectile 

dysfunction (ii) to symptomatically treat the erectile 

dysfunction. It did not find in the prior art the method of 

claim 1: long-term administration (i) to an individual with 

penile fibrosis (ii) in an effective amount to arrest or 

regress the fibrosis. 

 
26 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

to on-demand dosing of PDE5 inhibitors; it does not teach

long-term daily treatment. The only statement in Montorsi relating in any way to long-term treatment appears

in Montorsi’s discussion of a study showing that a onetime administration of sildenafil at bedtime increased 

nocturnal erections in men between 40 and 68 years of 

age with erectile dysfunction. Montorsi comments that 

the study “opened the door to further study investigating 

the possible dosage of sildenafil to be administered daily 

at bedtime.” Montorsi at 31. The study discussed by 

Montorsi, however, was not limited to a population of 

patients suffering from erectile dysfunction caused by an 

underlying fibrotic condition (or even aging or atherosclerotic patients who have a higher likelihood of an underlying fibrosis). 

The Board found that Whitaker taught the chronic 

administration of PDE5 inhibitors to individuals with 

erectile dysfunction and, in particular, that it taught

treating individuals with erectile dysfunction that is 

associated with atherosclerosis. The first of those findings is supported by substantial evidence, but the second 

is not.

Whitaker mentions atherosclerosis only once in its 39-

page disclosure. It does so when addressing an effect that 

Whitaker refers to as “vascular conditioning,” which was 

not previously seen in patients treated with PDE5 inhibitors. Whitaker at 12-13. Upon observing that effect in 

the case of chronic treatment of patients with erectile 

dysfunction, Whitaker states that “[i]t is expected that 

vascular conditioning occurs after chronic administration 

of the PDE5 inhibitor, for example, after about three daily 

doses of up to 10 mg, preferably after five days of daily 

dosing, and more preferably after seven days of daily 

dosing.” Id. at 13. Whitaker then states that “[i]t is 

theorized, but not relied upon herein that vascular conditioning is caused by a partial or complete reversal of 

circulatory dysfunctions in penile circulation arising from 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 27

conditions such as diabetes, atherosclerosis, smoking, 

hypertension, or a combination of such factors,” conditions 

that “result in thickening of the arterial wall, decreased 

arterial compliance, and decreased responsiveness to 

endogenous vasodilators, such as nitric oxide.” Id.

Whitaker, however, provides no data to support this 

“vascular conditioning” causation theory. None of the 

studies reported in Examples 5, 6, and 7 of Whitaker were 

expressly limited to atherosclerotic, or even aging, patient 

populations. E.g., Whitaker at 34 (PDE5 inhibitor in 

Example 6 was administered to “patients with male 

erectile dysfunction”). Nor can the presence of an underlying fibrotic condition be inferred, because the Board 

pointed to no findings regarding the rate of incidence of 

atherosclerosis in males with erectile dysfunction. In

sum, Whitaker provides no information about whether the

vascular conditioning effect was observed in erectile 

dysfunction patients with atherosclerosis and associated 

corporal fibrosis.

Indeed, Whitaker makes clear that the observation 

about “vascular conditioning” and its cause is speculative. 

Whitaker states that the “vascular conditioning” effect

was not previously observed, and notes that its relationship to circulatory dysfunctions such as atherosclerosis is 

merely “theorized.” Whitaker at 12-13. As such, Whitaker’s observation cannot serve as an express or implicit 

teaching. See, e.g., Star Scientific, Inc. v. R.J. Reynolds 

Tobacco Co., 655 F.3d 1364, 1375-76 (Fed. Cir. 2011) 

(prior art’s “speculative and tentative disclosure of what 

‘might’ or ‘may’ [explain the cause of a desired effect] does 

not sufficiently direct or instruct one of skill in this art”); 

Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1290 (Fed. 

Cir. 2006) (“[L]egal determinations of obviousness, as 

with such determinations generally, should be based on 

evidence rather than on mere speculation or conjecture.”).
28 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

Following its analysis of Whitaker, the Board found 

that persons of skill in the art would have had a reasonable expectation of success in treating erectile dysfunction 

in fibrotic patients, as in Montorsi, and doing so through 

long-term treatment, as in Whitaker. In so finding, 

however, the Board summarily dismissed LAB’s counterargument that those references would not have given rise 

to a reasonable expectation of success in treating erectile 

dysfunction in the subpopulation suffering from penile 

fibrosis.

According to LAB’s expert, it was widely believed at 

the time of the invention that the enzyme iNOS and its 

product nitric oxide were profibrotic, i.e., they exacerbated 

fibrotic conditions and the accompanying symptom of 

erectile dysfunction. It was known that nitric oxide

activates guanylate cyclase, which increases intracellular 

cyclic guanosine monophosphate (“cGMP”). It was also 

known that PDE5 inhibitors operate similarly: They 

inhibit the enzyme PDE5, which breaks down cGMP, so 

inhibiting PDE5 also leads to an increase in intracellular 

cGMP. LAB contends that the prevailing view in the field 

at the time of the invention was that PDE5 inhibitors

would also be profibrotic. Therefore, according to LAB, 

persons of skill in the art would not have prescribed a

PDE5 inhibitor on a long-term basis to treat erectile 

dysfunction in patients with penile fibrosis. 

The Board dismissed LAB’s argument as addressed 

only to the mechanism of action inherent in the claimed 

method, which it found was taught by the combination of 

Montorsi and Whitaker. That answer, however, does not 

address LAB’s point that even if the combination of 

Montorsi and Whitaker teach long-term treatment with a 

PDE5 inhibitor of individuals with some forms of erectile 

dysfunction, a person of skill in the art would not have 

been motivated to combine those references to treat

individuals with fibrosis-related erectile dysfunction

because, according to LAB, the results would have been 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 29

expected to be detrimental. See Institut Pasteur, 738 F.3d 

at 1346 (error to disregard prior art evidence of toxicity, 

which was relevant to question of whether skilled artisan 

would have a reasonable expectation of success in achieving the claimed invention). 

To be sure, LAB’s evidence is not undisputed. At the 

time of the invention, according to Lilly, the biochemical 

pathway was under study by those in the field as a way of 

addressing CVOD. And Whitaker, in discussing the 

possibility of such a treatment, does not single out atherosclerotic individuals (or others with an underlying penile 

fibrosis) and specifically warn against the profibrotic 

effects of long-term treatment with a PDE5 inhibitor.

The question remains whether a person of skill in the 

art would have had a reason to combine Montorsi, Whitaker, and Porst to treat penile fibrosis with a long-term 

regimen of a daily dosage of a PDE5 inhibitor, and would 

have had a reasonable expectation of success from doing 

so. Because the Board’s obviousness analysis was based 

on an erroneous construction of the claim language and 

an overly broad interpretation of Whitaker, and because 

the Board did not address the record evidence summarized above, we remand for the Board to make new findings as to whether there was an apparent reason to 

combine the prior art references and whether that combination would have rendered obvious the long-term administration of PDE5 inhibitors to treat penile fibrosis.8 

8 LAB contends (LAB Opening Br. 60-62) that the 

Board failed to consider the evidence of unexpected results as objective evidence of nonobviousness. As indicated above, the issue of unexpected results (and the related 

question of a reasonable expectation of success) is tied to 

the proper construction of the claim language. We there-

 
30 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

2. The Board also made no findings as to whether any 

reference or combination of references rendered obvious 

the claim limitation “arresting or regressing the at least 

one of a penile tunical fibrosis and corporal tissue fibrosis,” because the Board erroneously concluded that arresting or regressing fibrosis is an inherent effect of any 

regimen exceeding 45 days regardless of the dosage. The 

Board did not consider, for example, whether the chronic 

low dose of tadalafil (5 mg or 10 mg administered “daily” 

for 8 or 12 weeks) in Whitaker’s Example 6 would arrest 

or regress penile fibrosis, including the relevant inventor 

statements during prosecution that administration for 45 

days of an extremely high dose of sildenafil was required 

to achieve the arrest or regression of penile fibrosis, see 

supra note 5. On remand, the Board should make the 

findings necessary to determine whether the references 

render the “arresting or regressing” limitation obvious.

3. LAB also challenges the Board’s findings regarding 

the limitation “at a dosage up to 1.5 mg/kg/day for not less 

than 45 days.” But the Board’s findings on that issue are 

well founded. Porst discloses that taking up to 1.5 

mg/kg/day of a PDE5 inhibitor for three weeks is safe, 

well-tolerated, and effective as a treatment for erectile 

dysfunction. Whitaker teaches chronic dosing of PDE5 

inhibitor for at least 45 days. Whitaker does not explicitly 

disclose that dosing must occur every day, but it suggests

as much, noting that a “better response” was obtained 

“with increased frequency of dose.” Whitaker at 36 (better results reported with closer to daily compliance, in the 

context of comparing the subgroups in Example 6); see 

also id. at 38 (“Adverse events were . . . attenuated with 

continued daily treatment.”). And those remarks are 

supported by Montorsi’s observation that the study refore leave it to the Board on remand to address that issue 

in the first instance.

 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 31

viewed by Montorsi “opened the door to further study 

investigating the possible dosage of sildenafil to be administered daily at bedtime to prevent or treat [erectile 

dysfunction] in the elderly patient.” Montorsi at 31. 

In sum, Whitaker teaches long-term chronic treatment for more than 45 days, Montorsi and Whitaker 

suggest daily administration, and Porst and Montorsi 

teach a dosage of up to 1.5 mg/kg/day. The Board’s findings regarding the dosage and treatment period limitation 

are therefore supported by substantial evidence.

4. Because we agree with the Board that the “continuous long-term regimen” limitation is satisfied by the

administration of a PDE5 inhibitor “up to 1.5 mg/kg/day 

for not less than 45 days,” we conclude that the same

references teach “continuous long-term regimen.” The 

Board’s findings regarding that limitation are therefore 

supported by substantial evidence as well.

III

Because the Board’s obviousness determination was 

predicated on an erroneous claim construction of two of 

the limitations of claim 1, and because the Board did not 

make factual findings as to whether there was an apparent reason to combine the prior art references to treat 

penile fibrosis and whether a person of skill in the art 

would have had a reasonable expectation of success from 

such a combination, we remand this case to the Board. 

We also remand for the Board to make findings bearing 

on the obviousness of the “arresting or regressing” limitation.9 The Board’s order is vacated, and the case is re9 Although the dissent urges that we should resolve 

the obviousness question without a remand, it would be 

improper for us to do so in the absence of the necessary 

factual findings by the Board. Personal Web Techs., LLC 

v. Apple, Inc., No. 2016-1174, at 8-9 (Fed. Cir. Feb. 14, 

 
32 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

manded for further proceedings consistent with this 

opinion.

VACATED AND REMANDED

2017) (discussing the “basic principle[] of administrative 

law” that an agency must provide a full and reasoned 

explanation for its decision, which is necessary to both 

enable judicial review and “prevent judicial intrusion on 

agency authority”); Ariosa Diagnostics v. Verinata Health, 

Inc., 805 F.3d 1359, 1365 (Fed. Cir. 2015) (“[W]e must not 

ourselves make factual and discretionary findings that 

are for the agency to make.”) (citing SEC v. Chenery 

Corp., 332 U.S. 194, 196-97 (1947)); see also, e.g., Bilstad 

v. Wakalopulos, 386 F.3d 1116, 1126 (Fed. Cir. 2004) 

(“vacat[ing] the Board’s decision with respect to the 

written description requirement and remand[ing] for 

reconsideration under the proper test” because the court’s 

“resolution of the [written description] question” previously decided by the Board under an incorrect legal standard 

would “require[] fact findings this court is not permitted 

to make.”).

 
United States Court of Appeals 

for the Federal Circuit ______________________ 

LOS ANGELES BIOMEDICAL RESEARCH 

INSTITUTE AT HARBOR-UCLA MEDICAL 

CENTER,

Appellant

v.

ELI LILLY AND COMPANY,

Appellee

______________________ 

2016-1518

______________________ 

Appeal from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board, in No. IPR2014-

00752.

______________________ 

NEWMAN, Circuit Judge, concurring in part, dissenting

from the judgment.

I agree generally with the court’s discussion of the 

’903 patent and the prior art. However, I conclude that 

the Patent Trial and Appeal Board correctly held the 

claim invalid on grounds of obviousness and inherency. 

No dispositive error of law, no absence of support of 

dispositive findings by substantial evidence, has been 

shown. I would affirm the Board’s decision, and thus I

respectfully dissent from the ruling of vacatur and remand.
2 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

DISCUSSION

The subject claim of the ’903 patent is: 

1. A method comprising: 

a) administering a cyclic guanosine 3’,5’-

monophosphate (cGMP) type 5 phosphodiesterase

(PDE 5) inhibitor according to a continuous longterm regimen to an individual with at least one of 

a penile tunical fibrosis and corporal tissue fibrosis; and

b) arresting or regressing the at least one of the 

penile tunical fibrosis and corporal tissue fibrosis, 

wherein the PDE-5 inhibitor is administered at a 

dosage up to 1.5 mg/kg/day for not less than 45 

days.

’903 Patent, col. 68, lines 23–32. The references cited by 

the PTAB show the subject cGMP products for treatment 

of erectile dysfunction, and discuss the mode of action in 

erectile dysfunction. The cited references are in the same 

field of endeavor, and include a review article. I outline 

some relevant PTAB findings: 

• the prior art shows that the cGMP products of 

claim 1 were known PDE-5 inhibitors, and known 

to relieve erectile dysfunction; 

• the prior art shows use of these cGMP products 

in the claimed dosages and over extended time periods.

• the prior art shows that penile fibrosis was 

known to be a cause of erectile dysfunction. 

The PTAB held trial, with evidence and expert witnesses 

from both sides. The Board concluded that the subject 

matter of claim 1 would have been obvious in view of the 

cited references. Reversible error in this conclusion has 

not been shown, and the Board’s findings on which its 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 3

conclusion was based are supported by substantial evidence.

The court’s extensive opinion sets forth the relevant 

facts, which I repeat only as needed to explain why I 

conclude that our proper action is to affirm the decision of 

the PTAB.

PDE-5 inhibitors were known to treat erectile 

dysfunction, which was known to be caused 

by penile fibrosis. 

That penile fibrosis is a cause of erectile dysfunction, 

and that erectile dysfunction is relieved by treatment 

with these PDE-5 inhibitors, was known before the filing 

of the ’903 application. LABio stresses that erectile 

dysfunction was known to have other causes, such as 

diabetes, atherosclerosis, and psychological problems. 

However, on the prior art and expert testimony that when 

penile fibrosis was present it was affected by the PDE-5 

inhibitors, the Board found that this effect was inherent 

in the use of these products to treat erectile dysfunction.

There was no claim that the ’903 inventors discovered

that penile fibrosis is a cause of erectile dysfunction. 

Their work is described as relating to understanding the 

production of nitric oxide, and other scientific aspects of 

the mechanism of erectile dysfunction and how PDE-5 

inhibitors work. I do not diminish the scientific value of 

their investigations. However, this does not diminish the 

evidence and the Board’s findings that PDE-5 inhibitors

were known and used by others under the conditions set 

forth in claim 1.

Claim 1 is directed to use of the cGMP PDE-5 inhibitors in dosages and for periods shown in the prior art; and 

the Board found that this use existed in the prior art, 

with the effect on penile fibrosis inherent in this use. 

This finding is supported by substantial evidence. In 

Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1346 (Fed. 
4 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

Cir. 1999), the court explained that “if granting patent 

protection on the disputed claim would allow the patentee 

to exclude the public from practicing the prior art, then 

that claim is anticipated, regardless of whether it also 

covers subject matter not in the prior art.” 

We are reminded of the truism that “that which infringes if later anticipates if earlier.” Polaroid Corp. v. 

Eastman Kodak Co., 789 F.2d 1556, 1573 (Fed. Cir. 1986) 

(quoting Peters v. Active Mfg. Co., 129 U.S. 530, 537 

(1889)). Both parties have advised that LABio has 

charged Lilly with “willfully inducing infringement of the 

’903 patent by marketing Cialis®, whose active ingredient 

is the PDE-5 inhibitor tadalafil, to erectile dysfunction 

patients for daily use, knowing and intending that it 

would be used to treat the penile fibrosis of those erectile 

dysfunction patients suffering from that underling condition.” LABio Br. 12.1 I agree with the court that this 

representation is relevant to the issues of obviousness and 

inherency, for the prior art shows such daily use and at 

the claimed dosages. 

The cited references lead to the PTAB’s ruling of obviousness

The Montorsi reference is a review article published 

in April 2002, entitled “The Ageing Male and Erectile 

Dysfunction.” The Whitaker reference is an international

application published November 1, 2001, entitled “Daily 

Treatment for Erectile Dysfunction Using a PDE5 Inhibitor.” The Porst reference is an article entitled “Daily 

IC351 [tadalafil] Treatment of ED,” published in September 2000.2

1 The district court action has been stayed pending 

resolution of the PTAB proceedings.

2 LABio appeals the PTAB’s denial of priority to 

LABio’s provisional application, filed on October 22, 2002. 

 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 5

At the PTAB trial, witnesses discussed the mechanism whereby penile fibrosis is related to erectile dysfunction, and the mechanism of these cGMP compounds in 

PDE-5 inhibition. The PTAB found that “treatment of ED 

in elderly patients or patients with atherosclerosis, as 

suggested by both Montorsi and Whitaker, would result in 

treatment of patients with the fibrosis, as Montorsi teaches that corporal fibrosis is associated with ED in those 

patient populations.” PTAB Op. at 22. Substantial 

evidence supports this finding. 

The PTAB cited Montorsi, which is a review of the 

causes of erectile dysfunction, an ailment that had been 

extensively studied over the years. Montorsi reports on 

the use of cGMP compounds as PDE-5 inhibitors, and 

compiles information from many scientific publications. 

Montorsi describes studies investigating the causes of

erectile dysfunction in aging men, summarizing that “it 

seems reasonable to hypothesize that the ED from ageing 

is the result of atherosclerosis-induced cavernosal ischaemia leading to cavernosal fibrosis and veno-occlusive 

dysfunction.” Montorsi at 31. 

Montorsi describes a study “wherein sildenafil was 

taken as required, but no more than once daily, over a 12 

week to 6 month period,” relied on by the PTAB to show 

“that sildenafil is an effective treatment of ED in elderly 

men.” PTAB Op. at 20. The court observes that “Montorsi teaches that corporal fibrosis is associated with erectile 

dysfunction in atherosclerosis of aging patient populations,” Maj. Op. at 25, and finds that substantial evidence

Lilly points out, without apparent dispute, that the relevant prior art would not be eliminated by LABio’s provisional application’s filing date of October 22, 2002, 

because all the references are prior art within the meaning of 35 U.S.C. § 102(a), even if they do not qualify under 

§ 102(b). Lilly Br. at 18.

 
6 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

supports “the Board[s] f[inding] that Whitaker taught the 

chronic administration of PDE5 inhibitors to individuals 

with erectile dysfunction.” Id. at 26. I agree. Whitaker 

states that “[t]o receive the full benefit of the present 

invention, chronic administration generally refers to 

regular administration for an extended period, preferably 

daily for three or more days, and still more preferably 

daily as long as the patient suffers from erectile dysfunction (in the absence of therapy).” Whitaker at 7. Lilly’s 

expert testified that “it would take ‘months’ to resolve ED 

based on circulatory dysfunction due to diabetes, atherosclerosis, smoking hypertension or a combination of those 

factors (i.e., Whitaker’s patient population).” Goldstein 

Decl. at 73. 

The court cites Whitaker’s statement that “[i]t is expected that vascular conditioning occurs after chronic 

administration of the PDE5 inhibitor, . . .” Maj. Op. at 26, 

citing Whitaker at 13. My colleagues criticize Whitaker’s 

lack of data on vascular conditioning. Id. at 27. However, 

that does not erase Whitaker’s teaching of chronic administration; and I point out that claim 1 does not mention or 

require vascular conditioning. The PTAB found that 

“Whitaker expressly teaches once daily dosing, teaches 

that treatment should last as long as the erectile dysfunction continues, and expressly teaches time periods of eight 

to twelve weeks.” PTAB Op. at 21. These findings are

supported by substantial evidence.

On this appeal LABio argues, as it did during prosecution, that “[t]he pending claims are directed to a ‘curative’ effect as opposed to a ‘palliative’ effect . . . for a longterm result (e.g., years), not a pathophysiology (function) 

for a very short-term result of a vasodilation (e.g., hours, 

maximum 2-3 days.” LABio Br. 10. However, the references show use longer than hours or 2-3 days. The Porst 

reference shows clinical trials in which tadalafil was 

administered for three weeks to “men with mild to moderate erectile dysfunction.” The dosages were in the 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 7

range shown in claim 1. The PTAB considered this reference in combination with the references to Montorsi and 

Whitaker; no error has been shown in this combination

for the treatment of erectile dysfunction. 

The PTAB’s decision accords with precedent

Precedent has dealt with a variety of factual situations in which a purported new use or property has been 

discovered for a known product, and patentability is 

sought on various premises. In Bristol-Myers Squibb Co. 

v. Ben Venue Laboriatories, Inc., 246 F.3d 1368 (Fed. Cir. 

2001), the court held that “[n]ewly discovered results of 

known processes directed to the same purpose are not 

patentable because such results are inherent,” having 

observed that the claimed term “for reducing hematologic 

activity” “merely express[ed] a purpose” and is “nonlimiting.” Id. at 1375, 1376. 

Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362 

(Fed. Cir. 2012), involved a claim to a method comprising 

“stabilizing conjunctival mast cells by topically administering” olopatadine in a known composition. Id. at 1364. 

The prior art described the known composition used as an 

antihistamine. Id. This court reversed the district court’s 

finding that a person would not have used the composition to stabilize mast cells because “a person of ordinary 

skill in the art at the time of the invention would have 

been motivated to use olopatadine to treat human eye 

allergies as claimed for its established antihistaminic 

efficacy.” Id. at 1369.

A contrary result was reached in Allergan, Inc. v. 

Sandoz Inc., 726 F.3d 1286 (Fed. Cir. 2013), where the

proposed claim was for “reducing the number of daily 

topical ophthalmic doses.” Id. at 1289. The court held 

that the enhanced efficacy was not taught in or suggested 

in the prior art or inherent in the prior dosage regimen,

Id. at 1294, and allowed claims to the multiple daily 

doses. In Alcon Research, the court allowed claims to a 
8 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

specific high concentration of a known product for treatment of allergic eye disease, finding that the prior art only 

taught lower concentrations, and that the higher concentration would not be obvious to try. Id. at 1370. And in 

Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir. 2001), the 

court upheld claims to the use of a known product to treat 

sleep apnea, holding that the prior use to treat anxiety

“did not address treatment of the underlying sleep apnea 

disorder” because the sleep apnea treatment was not 

inherent in the prior art’s anxiety treatment. Id. at 1060, 

1062–63. While LABio states that Allergan and Rapoport

support its position, each of those cases relies on facts 

missing here. 

Precedent thus illustrates that the later discovery of a 

new and unobvious use of a known product may be patentable when the standards of unobviousness are met. 

Here, however, penile fibrosis was known in the prior art 

to be a mechanism of causing erectile dysfunction. A 

person of ordinary skill would, as the PTAB found, use 

the claimed compounds at the claimed doses for the 

claimed duration, for the purpose of treating erectile 

dysfunction in patients with penile fibrosis. The PTAB’s 

findings are supported by substantial evidence, and its 

conclusions based thereon are in accordance with law. 

See Alcon Research, 687 F.3d at 1369 (“Given that the 

patent defines, and expressly claims, olopatadine concentrations that are ‘therapeutically effective’ to stabilize 

conjunctival mast cells, Kamei’s disclosure of overlapping 

concentrations, even if for a different purpose, meets 

these claim limitations.”). The PTAB’s decision should be 

affirmed.

Finality and the America Invents Act

I respectfully dissent from my colleagues’ judgment of 

vacatur and remand, for such further proceedings fail the 

policy and purpose of the America Invents Act, and should 

be invoked only when there are major defects in the PTAB 
LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY 9

proceeding, requiring activity and redetermination that is 

not available on the appellate record.

The court at its footnote 9 takes issue with my position that our appellate obligation is to decide the appeal 

on the record on which the appeal reaches us. The court 

states that if an aspect is insufficiently established in the 

PTAB proceeding, our appellate role is to remand, despite 

the usual protocol that when sufficient basis has not been 

provided to support a necessary ruling, the side with the 

burden of establishing that position, loses. When, as 

here, the dispositive facts are not in dispute, it is not 

customary to authorize the deficient party to return to the 

trial tribunal to try again.

The America Invents Act adds rigor to this protocol, 

for the AIA created an expedited administrative procedure with strict time limits. Within these time limits, the 

parties must present their case and the PTAB must make 

its decision. It negates a foundation of the AIA for the 

appellate tribunal simply to remand for further proceedings after the statutory deadline. Our obligation is to 

decide the appeal as it reaches us.

According to the majority, the Board did not find that 

the prior art taught “long-term administration (i) to an 

individual with penile fibrosis (ii) in an effective amount 

to arrest or regress the fibrosis.” Maj. Op. at 25 n.7, 31. 

Respectfully, the majority is incorrect, because the Board 

expressly found that the Whitaker reference taught longterm administration to patients with erectile dysfunction, 

and the Board expressly found that in some of those 

patients erectile dysfunction is caused by penile fibrosis. 

It is not necessary to return to the Board to find whether 

the prior art administered “an effective amount to arrest 

or regress the fibrosis,” id. at 25 n.7, because LABiomed 

has conceded that it does; that is the basis for its litigation position.
10 LOS ANGELES BIOMEDICAL v. ELI LILLY AND COMPANY

Our obligation is to review the rulings of law and fact 

on the record presented. On this record, preponderant 

evidence is on the side of obviousness. Thus the decision 

in this IPR proceeding should be affirmed, not vacated 

and remanded.

The America Invents Act was enacted to remedy the 

lack of expedition and to add predictability in infringement disputes, by assigning to an expert administrative 

tribunal and presumed expert federal court the resolution 

of some major patentability issues, with tight procedural

rules and deadlines. It was expected that in the normal 

course questions of patentability under Section 102 and 

103 would be reliably and speedily resolved. Implementing this policy, when we find analytic lapses by the PTAB, 

it appears that the statute contemplates that we will 

make the determination, on the record that was made at 

the Board. Indeed, the depth of briefing by the parties 

suggests that this was their understanding, too.

I don’t say that remands are never appropriate, but 

remands should be rare. Here the issues were fully 

developed, with eloquent argument all around, and an 

extensive Board opinion in which my colleagues find only 

slight gaps. Finality is available; it is our obligation to 

decide the merits.