Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-14-01614/USCOURTS-ca13-14-01614-0/pdf.json

Parties Involved:
Hospira, Inc.
Appellee
Ivera Medical Corporation
Appellant

Document Text:

United States Court of Appeals 

for the Federal Circuit ______________________ 

IVERA MEDICAL CORPORATION,

Plaintiff-Appellant

v.

HOSPIRA, INC.,

Defendant-Appellee

______________________ 

2014-1613, 2014-1614

______________________ 

Appeals from the United States District Court for the 

Southern District of California in Nos. 3:11-cv-01246-HRBB, 3:12-cv-01582-H-RBB, Judge Marilyn L. Huff.

______________________ 

Decided: September 8, 2015

______________________ 

DAVID J.F. GROSS, Faegre Baker Daniels LLP, Minneapolis, MN, argued for plaintiff-appellant. Also represented by THEODORE MICHAEL BUDD, CHAD DROWN, EVA 

BETH STENSVAD. 

ADAM R. HESS, Venable LLP, Washington, DC, argued 

for defendant-appellee. Also represented by MEAGHAN 

KENT, MARTIN LYNN SAAD; PAUL F. STRAIN, Baltimore, 

MD.

______________________ 

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2 IVERA MEDICAL CORPORATION v. HOSPIRA, INC. 

Before NEWMAN, REYNA, and TARANTO, Circuit Judges.

REYNA, Circuit Judge.

Ivera Medical Corp. (“Ivera”) sued Hospira, Inc.

(“Hospira”) in the Southern District of California alleging 

infringement of U.S. Patent Nos. 7,780,794 (the ’794 

patent), 7,985,302 (the ’302 patent), and 8,206,514 (the 

’514 patent). The district court granted summary judgment of invalidity, finding the asserted patent claims 

obvious under 35 U.S.C. § 103. Ivera appeals. For the 

reasons that follow, we reverse and remand. 

BACKGROUND

A. The Patents-in-Suit.

The ’514 patent is a continuation of ’302 patent, which 

is a continuation of the ’794 patent. All three patents 

share the same written description.1 The patents explain 

that medical implements, such as catheters and luer 

ports, are common sites for transmissions of pathogens 

into patients. ’794 patent col. 1 ll. 32–35. To prevent 

these types of transmissions, medical staff traditionally 

swabbed a site before making connections to medical 

implements. Id. col. 1 ll. 41–45. The swabs came in a 

small pad of cotton gauze soaked in a cleaning agent (e.g., 

isopropyl alcohol) and packed in a foil package to prevent 

evaporation. Id. col. 1 ll. 45–47. After swabbing, the site 

is allowed to dry, killing any pathogens. Id. col. 1 ll. 48–

55. 

In practice, these swabbing procedures were often

“overlooked” or “poorly executed.” Id. col. 1 ll. 56–58. To 

overcome this problem, the inventors provided a cleaning 

device that includes a cap that, when used, reliably disin1 For simplicity, we refer below to the written description of the ’794 patent.

 

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fects a medical implement. For example, FIG. 6, provided 

below, shows a cross-sectional diagram of a cleaning 

device 100 that includes a cap 102. Id. col. 6 ll. 19–20. 

Cap 102 includes threads 105 adapted to receive a medical implement, and first and second cleaning materials 

107 and 108. Id. col. 6 ll. 26–30 and 49-52. When the 

medical implement is twisted into cap 102, first cleaning 

material 107 compresses radially, cleansing the sides of 

the implement, and second cleaning material 108 compresses axially, cleansing the foremost surface of the 

implement. See id. col. 7 ll. 27–33. 

Central to the parties’ arguments on summary judgment are openings that permit venting of the interior of 

the cap. The patents describe two embodiments of these 

openings. First, in FIG. 6, threaded ring 106 can create 

“a small vent aperture or opening” relative to the inner 

wall of cap 102 to allow evaporation of the cleaning agent 

in cap 102. Id. col. 6 ll. 37–43. Second, in FIG. 14 (provided below), holes 164 are formed in housing 162 of the 

cap. Holes 164 “can promote evaporation of the cleaning 

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agent, particularly when the housing covers a site of a 

medical implement to be disinfected.” Id. col. 8 ll. 15–17.

The asserted claims of the patents-in-suit recite cleaning devices that include a “second opening,” “aperture,” or 

“means for venting” that inhibit pressure buildup and 

allow for evaporation.2 For example, claim 13 of the ’794 

patent recites:

13. A cleaning device for a medical implement, the 

cleaning device comprising:

a cap having a first opening to an inner cavity, an 

inner surface of the first opening including one or 

2 We refer to these limitations collectively as 

“vents.” 

 

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more threads adapted to receive a site of the medical implement;

a cleaning material formed of a compressible material that is at least partially secured in the inner 

cavity, the cleaning material containing a cleaning agent;

a second opening in the cap to allow evaporation of 

the cleaning agent from the inner cavity and to 

inhibit a buildup of pressure in the cap when the 

cleaning material is compressed by the site of the 

medical implement and a removable covering that 

covers the first opening and the second opening to

the inner cavity prior to coupling the threads of 

the cap with the site of the medical implement via 

the first opening.

’794 patent col. 10 ll. 1–17 (emphasis added). 

B. The Prior Art. 

1. Hoang. 

U.S. Patent Application Publication No. 2007/0112333 

(“Hoang”) describes a “device for antiseptically maintaining a patient fluid line access valve.” Hoang, ¶ 5. The 

parties focus their attention on FIG. 10b of Hoang, which 

is provided below. FIG. 10b shows a cap device 78 that 

has a lid 78a and a pad 80. Id. ¶ 43. Cap device 78 can be 

twisted onto a patient’s valve using its threads (not numerically referenced in FIG. 10b). Id. ¶ 44. Pad 80 can be 

used as a “dry” pad or a “wet” pad. Id. ¶ 43. When used 

as a “dry” pad, pad 80 is impregnated with an antimicrobial agent that maintains antiseptic conditions on the 

access portion of a valve. Id. ¶ 23. When used as a wet 

pad, pad 80 is impregnated with a cleaning agent and, 

optionally, an antimicrobial agent. Id. ¶ 27. In this latter

example, pad 80 can clean the valve as cap device 78 is 

twisted on to the valve. Id. ¶ 44. 

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2. Chin-Loy. 

U.S. Patent No. 5,954,957 (“Chin-Loy”) describes a 

cap adapted to cover blood ports or other hydraulic connection ports for medical devices such as hemodialysis 

machines. Chin-Loy col. 3 ll. 19–23. FIG. 1 of Chin-Loy, 

provided below, shows a cap 10 with a first end 12 defining a female portion 16, which receives a male blood port. 

Id. col. 3 ll. 54–57. Side wall 22 and end wall 24 together 

define a receptacle 34 that receives the male nipple. Id. 

col. 4 ll. 5–7. Cap 10 can be twisted onto a blood port 

when the port is threaded or can “snap on” for unthreaded 

ports. Id. col. 4 ll. 32–35, col. 4 ll. 46–49. Cap 10 also 

includes a channel 66 defined by interior surface 28. Id.

col. 5 ll. 1–2. When cap 10 is attached to a blood port, 

channel 66 permits “venting of the medical device through 

the male blood nipple while maintaining an internal 

condition of the medical device until time of use.” Id. col. 

2 ll. 41-43 and col. 5 ll. 12–15.

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3. White. 

U.S. Patent No. 5,242,425 (“White”) describes a catheter assembly that includes a distal member and a proximal member.3 FIG. 7 of White, provided below, shows an 

example catheter assembly that includes a distal member 

70 having a finger grip 72. White col. 7 ll. 23–25. Distal 

member 70 is connected to flexible catheter tubing 18 and 

proximal member 82. Id. col. 7 ll. 29–32. Proximal member 82 has a self-sealing septum 84 through which a 

needle can be inserted to introduce liquids into catheter 

tubing 18. Id. col. 7 ll. 1–6.

Distal member 70 has an externally threaded shoulder 74 that is adapted to receive internal threads of outer 

protective cap 78. Id. col. 7 ll. 26–27. Outer protective 

cap 78 contains a sponge 80 that is saturated with an 

3 In White, the “distal end” is the end closest to the 

patient and “proximal end” is the end exposed to the 

outside world. White col. 2 ll. 45–50. 

 

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antiseptic. Id. col. 7 ll. 27–29. When outer protective cap 

78 is twisted onto externally threaded shoulder 74, the 

antiseptic from sponge 80 can “bathe the exterior surfaces 

of distal member 70, proximal member 82, and selfsealing septum 84.” Id. col. 7 ll. 29–35. 

C. Prosecution History. 

In February 2007, Bobby Rogers and Paul DiPerna 

filed non-provisional application no. 11/705,805 (the “’805 

application”), which led to the ’794 patent. In response to 

a September 2009 Office Action, which rejected all of the 

claims as either anticipated by Hoang or obvious over 

Hoang and various secondary references, the applicant 

amended the claims to recite, inter alia, vents that allow 

for evaporation or drying of the cleaning agent. J.A. 

5412–18. In response, the examiner allowed the application. J.A. 5029–33. In the Notice of Allowance, the examiner stated that “the reviewed prior art does not disclose 

or render obvious a medical implement cleaning device 

comprising a cap having holes or openings for venting the 

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device while in use,” J.A. 5033, and that Hoang does not 

disclose “vent holes, apertures, or additional openings to 

inhibit vacuum [sic] in the cap cleaning device.” J.A. 

5034. The ’794 patent issued thereafter in August 2010. 

The ’794 and ’302 patents were each subject to ex 

parte reexamination. In each of these proceedings, the 

examiner initially rejected the claims over various references. In at least the reexamination of the ’794 patent, 

the examiner considered the Hoang reference. J.A. 5097–

98. The examiner determined that the challenged claims 

of the ’794 and ’302 patents were patentable over the cited 

prior art based at least partially on the vent limitations. 

J.A. 38; J.A. 54; J.A. 5097–98; J.A. 5161–62.

Hospira later requested inter partes reexamination of 

the patents-in-suit, which the United States Patent and 

Trademark Office granted. After the examiner rejected 

claims in an Action Closing Prosecution (“ACP”), Ivera 

attempted to enter seven declarations, including one from 

an inventor of the Hoang reference, Minh Hoang, and 

another from Dr. Alan Buchman, the sole inventor of a 

prior art reference relied on during the inter partes reexaminations, but not at issue here. J.A. 5473. In the Right 

of Appeal Notice (“RAN”), the examiner determined that 

these declarations would not be considered because Ivera 

had not explained why this evidence was not presented 

earlier in the proceedings. J.A. 5473. 

Assessing the merits, the examiner rejected all of the 

challenged claims as obvious over the combination of 

Hoang and Chin-Loy (among other rejections). J.A. 5467–

68, 5513–14, 5553–54. The examiner concluded that it 

would have been obvious to one of ordinary skill to include 

“the venting channel of Chin-Loy in the cap housing of 

Hoang because it would allow for venting from the cap 

interior while preventing the infiltration of microorganisms to maintain the sterile condition of the catheter 

access site.” J.A. 5468. The examiner also concluded that 

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because threaded luer connections are not fluid-tight, a 

threaded opening (such as the ones disclosed in Hoang 

and White) can meet the vent limitations. See J.A. 5521. 

Ivera informs us that it is appealing the rejections to the 

Patent Trial and Appeal Board. Appellant’s Br. 18. 

D. Procedural Posture. 

Ivera sued Hospira for infringement of the ’794 and 

’302 patents in 2011 and for infringement of the ’514 

patent in 2012. In October 2013, the district court issued 

its claim constructions for the disputed terms of all of the 

patents-in-suit. Relevant here, the district court construed the term “opening” or “first opening” to mean “an 

entrance or exit to the inner cavity of the cap,” “second 

opening” to mean “a second, distinct channel or pathway 

that extends from the interior to the exterior of the cap,” 

and “aperture” to mean “a channel, pathway, hole, gap, or 

split.” J.A. 5433, 5435, 5437. The district court also 

construed “means for venting” under 35 U.S.C. § 112, ¶ 

6,4 to mean “the following combination of proposed terms: 

(a) a threaded ring that fits into a groove that is formed in 

the inside edge surface of the cap near the opening, where 

the threaded ring includes or creates with the cap wall a 

small vent aperture or opening; (b) holes in the housing of 

the cap; and (c) permitted equivalents of (a) and (b).” J.A. 

5439. The parties do not challenge these constructions 

before us.

4 Paragraph 6 of 35 U.S.C. § 112 was replaced with 

newly designated § 112(f) when § 4(c) of the America 

Invents Act (AIA), Pub. L. No. 112-29, took effect on 

September 16, 2012. Because the applications resulting 

in the patents-in-suit were filed before that date, we refer 

to the pre-AIA version of § 112.

 

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In April 2014, the district court granted Hospira’s motion for summary judgment of invalidity. J.A. 9. The 

district court found that the scope of the prior art included 

Hoang, Chin-Loy, and White. J.A. 13. The court further 

found that the level of ordinary skill is a person with “a 

bachelor’s degree in mechanical engineering, biomedical 

engineering, or a comparable field with anywhere from 

two to five years’ work in the disposable medical device 

industry.” J.A. 16. 

Considering the differences between the prior art and 

the claimed inventions, the court found that the “patentsin-suit contain the same elements that perform the same 

functions they had been known to perform in the prior 

art,” J.A. 16, and that the “arrangement of elements in 

the asserted claims do[es] not yield anything other than 

predictable results,” J.A. 18. The court noted, however,

that Hoang does not disclose the vent limitations. J.A. 19. 

Still, a person of ordinary skill would not “need the benefit of hindsight to realize that adding a vent would relieve 

possible pressure on the inside of the cap.” J.A. 19. 

According to the court, a person of ordinary skill would 

recognize the benefits of adding a vent as allegedly taught 

in Chin-Loy, i.e., it would allow venting of the interior of 

the medical device through a blood port during sterilization. J.A. 19 (citing Chin-Loy col. 5 ll. 1–20). A person of 

ordinary skill would also recognize that adding a second 

opening would allow the cleaning agent to “vent onto the 

exterior of the medical implement, sterilizing a larger 

portion of it,” as allegedly described in White. J.A. 19 

(citing White col. 7 ll. 23–35). Thus, the district court 

determined that “the record demonstrates no triable issue 

of material fact on obviousness for the asserted claims of 

the patents-in-suit.” J.A. 20. The district court further 

found that Ivera’s evidence of secondary indicia of nonobviousness did not rebut this conclusion, stating that

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12 IVERA MEDICAL CORPORATION v. HOSPIRA, INC. 

ter regardless of evidence of secondary factors, and as a 

result fail to meet the requirement of § 103.” J.A. 21. 

Ivera timely appealed. We have jurisdiction under 28 

U.S.C. § 1295(a)(1). 

DISCUSSION

Summary judgment is appropriate if “the movant 

shows that there is no genuine dispute as to any material 

fact and the movant is entitled to judgment as a matter of 

law.” Fed. R. Civ. P. 56(a). We review a grant or denial of 

summary judgment under the law of the regional circuit, 

which in this case is the Ninth Circuit. Aristocrat Techs. 

Austl. Pty Ltd. v. Int’l Game Tech., 709 F.3d 1348, 1361 

(Fed. Cir. 2013). The Ninth Circuit reviews such a decision de novo. Humane Soc’y of the U.S. v. Locke, 626 F.3d 

1040, 1047 (9th Cir. 2010). That is, we apply the same 

standard applied by the district court. Lew v. Kona Hosp., 

754 F.2d 1420, 1423 (9th Cir. 1985). In doing so, we 

resolve factual disputes against the movant. Gen. Elec. 

Co. v. Joiner, 522 U.S. 136, 143 (1997). We must also 

take into account that invalidity of a patent must be 

shown by clear and convincing evidence. Microsoft Corp. 

v. i4i Ltd. P'ship, 131 S. Ct. 2238, 2243 (2011); see also 

Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).

Under 35 U.S.C. § 103, a patent may not be obtained 

“if the differences between the subject matter sought to be 

patented and the prior art are such that the subject 

matter as a whole would have been obvious at the time 

the invention was made to a person having ordinary skill 

in the art to which said subject matter pertains.”5 Obviousness is a legal question based on the following underlying factual inquiries: (1) the scope and content of the 

prior art; (2) the level of ordinary skill in the art; (3) the 

5 Again, we refer to the pre-AIA version of § 103.

 

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differences between the claimed invention and the prior 

art; and (4) secondary evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). “A party 

seeking to invalidate a patent on obviousness grounds 

must demonstrate by clear and convincing evidence that a 

skilled artisan would have been motivated to combine the 

teachings of the prior art references to achieve the 

claimed invention, and that the skilled artisan would 

have had a reasonable expectation of success in doing so.” 

InTouch Techs., Inc. v. VGO Commc'ns, Inc., 751 F.3d 

1327, 1347 (Fed. Cir. 2014) (internal citations and quotation marks omitted). Determining whether one of ordinary skill in the art would have been motivated to 

combine the teachings of different references is a flexible 

inquiry, and the motivation is not required to be found in 

any particular prior art reference. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007). 

Ivera argues that a person of ordinary skill in the art 

would not have been motivated to add a vent to Hoang’s 

cap. Appellant’s Br. 33. Instead, the record shows, according to Ivera, that the conventional wisdom among 

those skilled in the art was that disinfecting caps should 

be fluid tight. Id. Hospira responds that Chin-Loy describes benefits of venting a cap, which would have motivated a person of ordinary skill to add a similar vent to 

Hoang’s cap. Appellee’s Br. 29. Hospira also cites the 

written description of the patents-in-suit as encouraging 

evaporation of cleaning agents. Id. A person of ordinary 

skill in the art would also have, according to Hospira,

seen the benefit of bathing the exterior of a cap, as allegedly described in White. Id. at 31. 

We agree with Ivera that record evidence establishes 

a genuine dispute over whether a person of ordinary skill 

would have been motivated to add a vent to Hoang’s 

disinfecting cap. During the inter partes reexaminations, 

Ivera submitted multiple expert declarations. As noted 

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14 IVERA MEDICAL CORPORATION v. HOSPIRA, INC. 

tions because Ivera did not establish why it had not 

submitted them earlier. Hospira does not, however, 

challenge Ivera’s reference to these declarations at the 

summary judgment stage before the district court. The 

declarations indicate that a person of ordinary skill would 

have desired fluid-tight disinfecting caps to retain the 

cleaning agent included within the cap. For example, 

Ivera relies on a declaration from an inventor of the 

Hoang reference, Minh Hoang. In his declaration, Minh

Hoang states that “[a]t the time of my invention, it was 

the understanding and belief of persons of ordinary skill 

in the art, such as myself, that such a cap should seal over 

the access portion of the access valve and retain the 

cleaning solution contained in the cap.” J.A. 5652. Referring to the cap described in the Hoang reference, Minh

Hoang explains the cap “avoided using any pathways or 

channels out of the housing of the cap during placement 

or use on the access valve, because doing so would allow 

an exit of the cleaning solution from the cap, which I 

believed would reduce the effectiveness of the cap.” J.A. 

5653. Although the statements of an inventor are not 

controlling as to the content of a patent application, 

Hospira does not challenge Minh Hoang’s assertion that 

he is a person of ordinary skill. Ivera’s expert, Karl 

Leinsing, agreed with Minh Hoang that one of ordinary 

skill in the art would not seek to add a vent to Hoang’s 

cap because doing so would cause the loss of cleaning 

solution. J.A. 5618. Karl Leinsing added that, in his 

opinion, fluid-line connections are generally presumed to 

be “fluid-tight to avoid leakage of any such fluid into the 

hospital environment.” J.A. 5585. 

Ivera also submitted a declaration from Dr. Alan 

Buchman, the sole inventor of a prior art patent cited in 

the inter partes reexaminations. In his declaration, Dr. 

Buchman states that his goal in creating a catheter 

cleaning device was to “create a device that would form a 

fluid-tight seal over the injection port and continuously 

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bathe the surface of the injection port entrance in the 

antimicrobial solution to obtain the best possible disinfection” and that “[e]stablishing and maintaining a fluidtight seal over the injection port was an important aspect 

of my design.” J.A. 5293. It was “commonly understood,” 

according to Dr. Buchman, that effective disinfection of 

the surface of the injection port “required that it be continuously bathed in the antimicrobial fluid.” J.A. 5293-94. 

Hospira argues that the prior art provides reasons to 

add a vent to Hoang’s cap. Appellee’s Br. 29. For example, Chin-Loy describes a channel that permits venting of 

the medical device during sterilization. Chin-Loy col. 5 ll. 

13–15. Chin-Loy, however, relates to blood ports of hemodialysis machines. Id. col. 3 ll. 19–23. Hospira cites no 

evidence explaining how this description is relevant to 

disinfecting caps. Hospira has not explained, for example, 

whether disinfecting caps like the one described in Hoang 

are sterilized or would benefit from venting during such a 

sterilization procedure. Chin-Loy thus does not foreclose 

a genuine dispute over whether a person of ordinary skill 

would have been motivated to add a vent to Hoang’s cap. 

Hospira also cites the following passage of the ’794 

patent’s written description as indicating that a person of 

ordinary skill in the art would not seek to retain the 

cleaning solution, but rather seek to have the cleaning 

solution evaporate: 

The site should be allowed to dry, usually twenty 

to thirty seconds, immediately prior to making 

any connection. This ‘drying’ period is important: 

when alcohol dries, it breaks open the cellular 

walls of microorganisms, thereby killing them. 

’794 patent col. 1 ll. 51–55. This passage, however, relates to manual swabbing of a site, and Hospira presents 

no evidence relating these teachings to the use of disinfecting caps. In fact, earlier in the same paragraph, the 

patents explain that caps are designed to retain the 

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cleaning agent, explaining that the swabs are packed 

individually in a foil package to “retain the alcohol within 

the package and to prevent evaporation.” Id. col. 1 ll. 45–

47. In any event, the tradeoff between the desire to retain 

the cleaning agent and the patents’ disclosure regarding 

drying is a factual matter left to the factfinder. 

Finally, Hospira points to White’s disclosure of bathing “the exterior surfaces of distal member 70, proximal 

member 82, and self-sealing septum 84.” White col. 7 ll. 

29–35. The parties dispute whether this disclosure means 

that the antiseptic bathes only threaded shoulder 74 of 

distal member 70 (as Ivera asserts), or if the antiseptic 

drips down the outside of distal member 70 (as Hospira 

asserts). Appellant’s Br. 28; Appellee’s Br. 31. White is 

not clear on which interpretation is correct, and neither 

side points to any other evidence favoring one interpretation. This dispute over the content of White is a factual 

dispute that we must resolve in Ivera’s favor at the summary judgment stage. Plantronics, Inc. v. Aliph, Inc., 724 

F.3d 1343, 1356-57 (Fed. Cir. 2013); Gen. Elec. Co., 522 

U.S. at 143. The cited passage from White does not, 

therefore, indicate that one of ordinary skill in the art 

would have sought to add a vent to Hoang’s cap. 

CONCLUSION

For the foregoing reasons, we hold that Ivera established a genuine dispute over whether one of ordinary 

skill in the art would have been motivated to add a vent 

to the disinfecting cap described in Hoang. Accordingly, 

we reverse the district court’s entry of summary judgment 

of invalidity. 

REVERSED AND REMANDED 

COSTS

No Costs.

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