Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-azd-2_12-cv-02110/USCOURTS-azd-2_12-cv-02110-2/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 35:271 Patent Infringement

---

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

WO

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF ARIZONA

Clerisy Corporation, et al.,

Plaintiffs, 

v.

Airware Holdings, Inc., et al., 

Defendants.

)

)

)

)

)

)

)

)

)

)

CV 12-2110-PHX-PGR

ORDER

After holding a Markman hearing on June 10, 2013, the Court enters the following

claim construction Order.

I. Background

Plaintiff Reed Transition Technologies, LLC, is the owner by assignment of United

States Patent No. 6,295,982 (“the Patent”), issued by the United States Patent and

Trademark Office (“PTO”) on October 2, 2001. (Doc. 59, Ex A.) The Patent is for an

“Apparatus for and Methods of Administering Volatile Substances into an Inhalation Flow

Path.” (Id.) Plaintiff Clerisy Corp. manufactures, markets, and distributes Aromahaler®

Nasal SoftStripsTM using the patented apparatus. Defendants market, sell, and distribute

“AIR” branded nasal products, which, like the Nasal SoftStrips, are infused with

aromatherapeutic essential oils. 

Plaintiffs allege that Defendants are infringing the Patent. On July 26, 2012, they filed

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 1 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 2 -

a complaint in the Western District of New York. The case was transferred to the District

of Arizona in October 2012. Plaintiffs filed an amended complaint on November 11, 2012.

(Doc. 59.) Defendants filed an answer and counterclaims on December 6, 2012. (Doc. 62.)

The parties have asked the Court to construe eight of the Patent’s claim terms.

Pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996), the Court

must construe the claims as a matter of law. The parties have filed briefs supporting their

proposed constructions of the terms. Having considered the arguments and evidence

presented in the parties’ briefs, exhibits, and at the Markman hearing, the Court construes the

disputed terms as set forth below.

II. Legal standards

Section 112 of the Patent Act provides that a patent specification “shall contain a

written description of the invention, and of the manner and process of making and using it

in such full, clear, concise, and exact terms as to enable any person skilled in the art to which

it pertains . . . to make and use the same.” 35 U.S.C. § 112. The section further provides that

a specification “shall conclude with one or more claims particularly pointing out and

distinctly claiming the subject matter which the applicant regards as his invention.” Id. “It

is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to

which the patentee is entitled the right to exclude.’” Phillips v. AWH Corp., 415 F.3d 1303,

1312 (Fed.Cir. 2005) (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc.,

381 F.3d 1111, 1115 (Fed.Cir. 2004)). 

Claim construction, which is the determination of the meaning of the terms in a patent,

is a question of law exclusively within the province of the Court. Markman, 517 U.S. at 372.

To interpret claims, the court first considers the claims themselves. Vitronics Corp. v.

Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir. 1996). The court should “look to the words

of the claims themselves,” giving them “their ordinary and customary meaning,” unless

clearly stated otherwise. Id. The “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

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 2 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 3 -

time of the invention.” Phillips, 415 F.3d at 1313 (9th Cir. 2005); see also Texas Digital Sys.,

Inc. v. Telegenix, Inc., 308 F.3d 1193, 1202 (Fed.Cir. 2002) (“The terms used in the claims

bear a ‘heavy presumption’ that they mean what they say and have the ordinary meaning that

would be attributed to those words by persons skilled in the relevant art.”).

After the claims themselves, the court looks to the patent specification. Vitronics, 90

F.3d at 1582. The specification is highly relevant to the claim construction analysis and

usually is dispositive. Phillips, 415 F.3d at 1315. The specification is the single best guide

to the meaning of a disputed term. Id. Courts therefore relies heavily on the written

description of the claims in the specification for guidance when conducting claim

construction. Id. at 1317.

The specification may give a special definition to a claim term that differs from the

meaning it otherwise would have. Id. at 1316. In such cases, the inventor’s special definition,

or lexicography, governs. Id. In other cases, the specification intentionally may disclaim or

limit the scope of the claim. Id.

When reviewing the specification, however, courts must avoid reading limitations

from the specification into the claims. Id. at 1323. To avoid importing limitations, the court

must consider the purposes of the specification, which are to teach and enable those of skill

in the art to make and use the invention and to provide the best way for doing so. Id.

In addition to the claims themselves and the specification, courts should consider the

patent’s prosecution history. Phillips, 415 F.3d at 1317. The prosecution history consists of

the record of the proceedings before the PTO and includes the prior art cited during the

examination of the patent. Id. The prosecution history, which is part of the “intrinsic

evidence,” provides evidence of how the PTO and the inventor understood the patent. Id. The

prosecution history often informs the meaning of the claim language by demonstrating how

the inventor understood the invention and whether the inventor limited the invention in the

course of the prosecution, thereby making the claim scope narrower than it otherwise would

be. Id.

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 3 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 4 -

Although the intrinsic evidence is the most important for claim construction, the court

also may rely on extrinsic evidence if necessary. Extrinsic evidence is all evidence external

to the patent and prosecution history, such as expert and inventor testimony, dictionaries, and

learned treatises. Id. Although it may prove useful, extrinsic evidence is less significant than

the intrinsic record for determining the meaning of claim language. Id. In most situations,

analysis of the patent and its prosecution history will resolve any ambiguity in a disputed

claim term. Vitronics, 90 F.3d at 1583.

“Ultimately, the interpretation to be given a term can only be determined and

confirmed with a full understanding of what the inventors actually invented and intended to

envelop with the claim.” Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250

(Fed.Cir. 1998) (citing Markman, 517 U.S. at 389). “The construction that stays true to the

claim language and most naturally aligns with the patent’s description of the invention will

be, in the end, the correct construction.” Id. Therefore, “[a] claim construction is persuasive,

not because it follows a certain rule, but because it defines terms in the context of the whole

patent.” Id.

III. Discussion

The parties agree that the “key teaching” of the Patent is “introducing a vapor of

volatile substance into an inhalation flow path.” The abstract of the patent reads: “A method

of introducing a vapor of a volatile substance into an inhalation flow path of a respiratory

organ, the method comprising the steps of providing a carrier having a volatile substance and

engaging the carrier at the inhalation flow path of the respiratory organ.” (Doc. 59, Ex. A.)

The patent includes 17 claims. (Id.) Plaintiffs accuse Defendants of infringing claims

1, 11, and 15. (Id.) Claims 1 and 11 are independent claims. (Id.) They are directed,

respectively, to a method and a vehicle for “introducing a vapor of at least one volatile

substance into an inhalation flow path of a respiratory organ.” (Id.) The method comprises

the steps of:

providing a carrier conformable to a surface of the skin;

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 4 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 5 -

providing the carrier with at least one volatile substance;

providing a barrier coupled to a surface of the carrier, the barrier being

substantially impermeable to the one or more volatile substances carried by

the carrier; and

engaging the carrier to the surface of the skin proximate an inhalation flow

path of a respiratory organ with the barrier adapted to be interposed between

the carrier and the skin to prevent the one or more volatile substances from

contacting the skin.

(Id.) 

All of the disputed terms are in Claims 1 and 11. The parties’ proposed constructions

of the terms are set forth in their opening claim construction briefs. (Docs. 85, 88.) 

The chart below summarizes the Court’s construction of the contested claim terms.

It is followed by the Court’s supporting analysis.

Disputed Claim Term Construction

Volatile substance “A substance that readily vaporizes or evaporates.”

Carrier “The portion of the vehicle or device that carries or

provides at least one volatile substance.”

Barrier “The portion of the vehicle or device that prevents

contact between the skin and the volatile

substance.”

Coupled to “Connected to.”

Substantially impermeable to

one or more volatile substances

“Preventing passage of most or all of the one or

more volatile substances.”

Proximate an inhalation flow

path

“Close to or within the entrance to the mouth and/or

the nasal passages and not on the bridge of the

nose.”

Engaging the carrier to a surface

of the skin

“Attaching the vehicle to the skin.”

Means for engaging the carrier

to the surface of the skin

Function: “Attaching the vehicle to the skin

proximate an inhalation flow path.”

Structure: “Adhesive, clamp, deformable element,

or deformable member.” 

A. “Volatile substance” 

Claims 1 and 11 refer to a method and vehicle “providing the carrier with at least one

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 5 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 6 -

volatile substance.” Plaintiffs define “volatile substance” as “a substance that is readily

vaporizable, including, for example, essential oils.” Defendant propose the following

construction: “a liquid or solid material that readily evaporates at ambient pressure and

temperature.”

The parties agree that “the technical meaning of a volatile substance is a substance

that readily transitions to a gas or vapor (i.e. vaporizes)” (Doc. 89 at 3) or “a substance that

readily vaporizes or evaporates” (Doc. 91 at 7). Defendants argue, however, that Plaintiffs’

construction is incomplete and potentially misleading. They contend that it is accurate to

qualify “volatile substance” with the phrase “liquid or solid” because a substance that

vaporizes is by definition not a gas. (Id.) They also argue that adding the phrase is

appropriate because “volatile substance” is a “technical chemistry term that a lay jury may

not know.” (Id. at 4.) Defendants likewise assert that the phrase “at ambient pressure and

temperature” is technically accurate and proper. (Id. at 5.)

Plaintiffs argue that it is inappropriate to read these additional limitations into the

specification. The Court agrees. “Where a specification does not require a limitation, that

limitation should not be read from the specification into the claims.” Intel Corp. v. U.S. Int’l

Trade Comm’n, 946 F.2d 821, 836 (Fed.Cir. 1991). Neither of the limitations proposed by

Defendants is required, nor would a jury would not fail to understand what is meant by

“substance” or “readily”

Accordingly, the Court will construe “volatile substance” as “a substance that readily

vaporizes or evaporates.”

B. “Carrier,” “Barrier,” “Substantially impermeable to one or more volatile

substances,” and “Coupled to.”

Claims 1 and 11 specify a vehicle and method “providing a barrier coupled to a

surface of the carrier, the barrier being substantially impermeable to the one or more volatile

substances carried by the carrier.”

Plaintiffs define “carrier” as “a portion of the vehicle or device that carries or provides

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 6 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 7 -

at least one volatile substance.” Defendants propose the following construction: “a distinct

layer comprised of a substantially absorbent material that can take up and hold the volatile

substance, while allowing the release of the vapor of the volatile substance.” Plaintiffs define

“barrier” as “a portion of the vehicle or device that prevents contact between the skin and the

volatile substance.” Defendants propose “a distinct layer comprised of a different material

than the carrier that prevents the volatile substance from contacting the skin.”

In support of their proposed constructions, Defendants assert that “carrier” and

“barrier” must be defined as separate and distinct layers, composed of different materials,

because the two layers perform opposing functions. Defendants note that the vehicles

disclosed in the specification are composed of distinct barrier and carrier layers, and that “in

describing four of the five embodiments, the patentee explicitly states that the vehicle is

‘comprised of a series of layers.’” (Doc. 85 at 3.) Defendants also argue that the “carrier”

must consist of a “substantially absorbent material” and that the term “portion,” as used by

Plaintiffs, is too broad.

Plaintiffs counter that the claims of the Patent require only the presence of a “carrier”

and “barrier” in the vehicle or device. There is no requirement of “distinct layers,” and the

phrase does not occur in the claims. Plaintiffs argue that a single material can be used as a

“carrier” and a “barrier.” They further assert that the manner in which the vehicle carries a

volatile substance while preventing contact with the skin is a design choice. Therefore,

although a “carrier” may consist of a substantially absorbent material, as it is in one of the

design choices described in the Patent, such a definition is not required. 

The Court finds Plaintiffs’ position more convincing, and will adopt their proposed

constructions of “barrier” and “carrier.” Plaintiffs correctly note that “Defendants’ proposed

constructions rely on limitations imported from the specification into the claims.” (Doc. 91

at 2.) As the court explained in Phillips, “although the specification often describes very

specific embodiments of the invention, we have repeatedly warned against confining the

claims to those embodiments. . . . In particular, we have expressly rejected the contention that

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 7 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 8 -

if a patent describes only a single embodiment, the claims of the patent must be construed

as being limited to that embodiment.” 415 F.3d at 1323; see Liebel-Flarsheim Co. v. Medrad,

Inc., 358 F.3d 898, 906 (Fed.Cir. 2004) (reiterating that “this court has expressly rejected the

contention that if a patent describes only a single embodiment, the claims of the patent must

be construed as being limited to that embodiment”). 

Furthermore, “[t]hat claims are interpreted in light of the specification does not mean

that everything expressed in the specification must be read into all the claims.” Teleflex, Inc.

v. Ficosa North America Corp., 299 F.3d 1313, 1326 (Fed.Cir. 2002) (quoting Raytheon Co.

v. Roper Corp., 724 F.2d 951, 957 (Fed.Cir. 1983)). In Teleflex, the court ruled that the term

“clip” was not confined to the embodiment described in specification, which would limit

“clip” to a structure having a single pair of legs. 299 F.3d 1313, 1326–28. The court

explained that there were no clear statements in the specification or prosecution history

indicating that the scope of claim should be so limited, noting, for example, that “[t]he

language of asserted claim 1 does not support limiting the claim to a ‘single pair of legs.’

Neither ‘single’ nor ‘pair of legs’ appears in claim 1.” Id. at 1327. The court concluded that

the district court “erred by importing the ‘single pair of legs’ limitation from the specification

into the claim.” Id. at 1328. 

A similar analysis applies to Defendants’ attempt to import into claims 1 and 11 the

limit of “distinct layers.” The phrase “distinct layer” does not appear in the claims or the

specifications. Defendants note that the embodiments describe vehicles containing carrier and

barrier layers. Similarly, Defendants assert that because all of the embodiments disclosed in

the specification include a carrier made of a substantially absorbent material, the term carrier

must be so defined. Again, however, it is improper to confine a claim to the embodiments set

forth in the specification. Moreover, “the specification need not describe every embodiment

of the claimed invention.” Netword, LLC v. Centraal Corp., 242 F.3d 1347, 1352 (Fed.Cir.

2001); see Epistar Corp. v. International Trade Com’n, 566 F.3d 1321, 1337 (Fed.Cir. 2009)

(rejecting accused infringer’s argument that the term “substrate” had to have a certain

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 8 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 9 -

thickness, provide structural support, and be limited to a single layer since the disclosure in

the specification was only for an “exemplary” embodiment).

Plaintiffs also argue that the “distinct layer” limitation would improperly exclude “an

embodiment disclosed in the specification in which the carrier is comprised of several layers

sandwiched together.” (Doc. 91 at 3.) This embodiment includes a carrier that consists of two

other members “sandwiched together with a suitable adhesive and each consisting of a

natural or synthetic sponge-like or substantially absorbent,” with a “macrocapsule containing

one or more volatile substances” captured between the members. (Doc. 86-1, col. 6, ll. 8-12,

and FIG. 16.) As Plaintiffs note, in this embodiment the carrier, being comprised of two

members and a macrocapsule, cannot accurately be defined as a “distinct layer.” Courts

“normally do not interpret claim terms in a way that excludes embodiments disclosed in the

specification.” Oatey Co. v. IPS Corp., 514 F. 3d 1271, 1276 (Fed.Cir. 2008). For this reason

too, the “distinct layer” limitation is not properly imported into the claim.

In addition, Defendants’ proposed construction of carrier is inappropriate under the

doctrine of claim differentiation, which holds that “the presence of a dependent claim that

adds a particular limitation raises a presumption that the limitation in question is not found

in the independent claim.” Liebel–Flarsheim, 358 F.3d at 910; see Curtiss–Wright Flow

Control Corp. v. Velan, Inc., 438 F.3d 1374, 1381 (Fed.Cir. 2006) (explaining that “claim

differentiation takes on relevance in the context of a claim construction that would render

additional, or different, language in another independent claim superfluous”); Phillips, 415

F.3d at 1315 (“The presence of a dependent claim that adds a particular limitation gives rise

to a presumption that the limitation in question is not present in the independent claim.”).

Furthermore, independent claims are generally given broader scope so as to avoid rendering

corresponding dependent claims redundant. Id. at 1324 (citing Dow Chem. Co. v. United

States, 226 F.3d 1334, 1341 (Fed.Cir.2000)). 

Dependent claim 12 describes a “vehicle of claim 11, wherein the carrier includes a

substantially absorbent member.” Therefore, there is a presumption that the “substantially

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 9 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 10 -

absorbent member limitation,” contrary to Defendants’ construction, is not found in

independent claim 11. Defendants are correct that the written description can overcome the

claim differentiation presumption in certain circumstances, but those circumstances are not

present here. The effect of ignoring the doctrine in this case “would render the dependent

claims superfluous or even invalid.” Abbott Laboratories v. Sandoz, Inc., 529 F.Supp.2d 893,

907 (N.D.Ill. 2007).

 Next, Plaintiffs define “substantially impermeable to one or more volatile substances”

as “preventing passage of most or all of the one or more volatile substances.” Defendants

argue that the phrase does not need to be construed beyond its plain meaning. The Court will

adopt Plaintiffs’ construction, which is consistent with the ordinary and customary meaning

of the words, and accurately describes the function of the barrier as set forth in the

specification. 

 Finally, Plaintiffs define “coupled to” as “connected or adjacent to.” Defendants

propose the following definition: “the distinct carrier layer is affixed to the distinct barrier

layer.” The parties agree that “connected” is a fair construction of “coupled to.” (Doc. 85 at

12.) 

Plaintiffs argue that their definition is consistent with the construction of the term

adopted by the court Federal Circuit in Johnson Worldwide Associates, Inc. v. Zebco Corp.,

175 F.3d 985, 992 (Fed.Cir. 1999), which held that the “clear meaning” of coupled “is not

limited to a mechanical or physical coupling.” Defendants counter that this definition is

inappropriate because a physical or mechanical coupling is required to connect the barrier

to the carrier; mere adjacency would not hold the carrier and barrier together. They also cite

the American Heritage Dictionary, which defines “adjacent” as “Close to; lying near” and

“Next to; adjoining.” 

The Court finds neither party’s definition of “couple to” satisfactory. While the Court

has rejected Defendants’ “distinct layers” limitation on the terms barrier and carrier, it

concludes that Plaintiffs’ proposed construction is overly expansive. “Adjacent,” which can

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 10 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 11 -

be defined as merely close to or near, is not consistent with Plaintiffs’ characterization of

their claims, which describe the carrier and barrier as being connected rather than merely

near each other. Accordingly, the Court will construe the term “coupled to” as “connected

to.” 

C. “Proximate an inhalation flow path,” “Engaging the carrier to a surface of the

skin,” and “Means for engaging the carrier to the surface of the skin.”

Claims 1 and 11 specify a vehicle and method “engaging the carrier to the surface

of the skin proximate an inhalation flow path of a respiratory organ with the barrier adapted

to be interposed between the carrier and the skin to prevent the one or more volatile

substances from contacting the skin.” The parties’ proposed constructions of these terms

address the placement of the device and the mechanism by which it is held in place. 

Plaintiffs define “proximate an inhalation flow path” as “close to or within the

entrance to the mouth and/or the nasal passages.” Defendants’ proposed construction is

“substantially immediately adjacent to the nasal or oral cavity openings, and not on the

bridge of the nose or inserted into the nasal cavity openings.”

The parties agree that “‘proximate an inhalation flow path’ means ‘close to’ or

‘substantially immediately adjacent to’ the openings of the mouth (oral cavity) or nasal

passages.” (Doc. 89 at 14.) Defendants contend, however, that “the plain meaning of ‘close

to’ or immediately adjacent to’ does not include inside of.” (Id.)

Plaintiffs argue that their construction of the term is supported by the specification,

which includes embodiments where the device is inserted into the nose. They note that the

specification for vehicle 20 states that “the entrance of mouth 22 and entrances of nose 23

as defined by the external openings into each of the nasal passages define inhalation flow

paths” and that “vehicle 20 is preferably worn against the skin adjacent or otherwise in one

or more of inhalation paths 24 and 25.” (Doc. 86-1, Col. 3, lines 14–19, 58–64). Figure 4 also

shows the vehicle inserted into the nose. 

Defendants assert, however, that the prosecution history shows that Plaintiffs

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 11 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 12 -

disclaimed any embodiments in which the devise is inserted into the nose. (Doc. 85 at

13–15.) According to Defendants, this disclaimer supercedes the embodiments in the

specification. 

During prosecution of claims, the Examiner cited U.S. Pat. Nos. 5,706,800 to Cronk

(“Cronk”) and 888,869 to Clark (“Clark”). (Doc. 86, Ex. G.) The Cronk reference discloses

a nasal dilator strip attached to the bridge of the nose. (See id., Ex. F). Defendants argue that

the “patentee unambiguously gave away embodiments of a device that is attached to the

bridge of the nose.” (Doc. 85 at 14.) Plaintiffs acknowledge that the patentee distinguished

his invention from Cronk by stating that “Cronk does not teach the use of a vehicle proximate

the inhalation flow path. The bridge of the nose is a substantially [sic] distance form [sic] the

flow path.” (Id., Ex. H at 9.) Plaintiffs note, however, that “the accused products in this case

are not placed on the bridge of the nose,” and argue there is no issue for the Court to resolve.

(Doc. 88 at 15.) The Court agrees with Defendants that Plaintiffs clearly and unmistakably

disavowed embodiments of vehicles positioned on the bridge of the nose. See Omega

Engineering, Inc, v. Raytek Corp., 334 F.3d 1314, 1325–26 (Fed.Cir. 2003) 

The Clark reference discloses an inhaler that is inserted into the nose. (Id.) The

patentee argued that Clark did not disclose a carrier that is “positioned proximate the flow

path” but instead “actually blocks the flow path.” (Id.) The examiner removed the Clark

reference. According to Defendants, however, by “blocks the flow path,” the patentee

necessarily meant “inserted into the nostrils.” (See Docs. 85 at 15, 89 at 12.) Therefore,

Defendants argue, because the patentee’s characterization of the invention as being placed

“proximate” the flow path did not include being inserted into the nose, “Plaintiffs have

forever given up those embodiments and cannot now as a matter of law attempt to recapture

those same embodiments in litigation.” (Doc. 85 at 15.) 

As additional evidence that Plaintiffs disclaimed embodiments inserted into the nose,

Defendants cite the patentee’s cancellation of proposed claim 22. (Doc. 89 at 12–13.) Claim

22 included the requirement that the vehicle be “within, at or below the openings of the

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 12 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 13 -

respiratory organ.” (Doc. 91, Ex. J at 34.) The patentee believed the claim was allowable

because “within, at or below the openings of the respiratory openings while leaving said

openings unrestricted is believed to define over the cited references.” (Id. at 38.) The

patentee later cancelled claim 22. The record shows that “the Examiner indicated to [the

patentee’s counsel] that prior art cited in prior office actions, specifically U.S. Patent No.

5,706,800 to Cronk et al and U.S. Patent No. 888,869 to Clark, read on the newly submitted

claim 22. Applicant agreed to cancel claim 22 because claims 1–16 and claim 21 are

allowable over the prior art of record.” (Id. at 41.)

Plaintiffs argue that the patentee simply agreed to cancel proposed claim 22 in order

to facilitate issuance of the patent, because the Examiner had already allowed claims 1–16

and claim 21. They note that notwithstanding the applicant’s statements regarding Clark, the

Examiner allowed claims inserting the device into the nose: dependent claim 15, which states

that, “The vehicle of claim 11, wherein the means includes a deformable element deformably

engagable against the respiratory organ,” and dependent claim 16, “The vehicle of claim 11,

wherein the means includes a clip clippingly engagable against the respiratory organ.”

Plaintiffs also note that there were several differences between proposed claim 22 and

the issued claims; for example, in contrast to the claims that were issued, claim 22 did not

include the limitation of a “barrier.” Therefore, Plaintiffs argue, because the requirement in

proposed claim 22 that the vehicle be “within, at or below the openings of the respiratory

organ” was not the only distinction between the proposed and issued claims, the cancellation

of claim 22 did not constitute a disclaimer.

The Court agrees with Plaintiffs that these details of the applicant’s cancellation of

proposed claim 22 do not support a finding of disclaimer. “[F]or prosecution disclaimer to

attach, our precedent requires that the alleged disavowing actions or statements made during

prosecution be both clear and unmistakable.” Omega, 334 F.3d at 1325–26; see Computer

Docking Station Corp. v. Dell, Inc., 519 F.3d 1366, 1374 (Fed.Cir. 2008) (“prosecution

disclaimer does not apply to an ambiguous disavowal.”) There is no “clear and

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 13 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 14 -

unmistakable” disavowal if the statements are subject to “more than one reasonable

interpretation.” Seirus Innovative Accessories, Inc. v. Bula America, Inc., No. 08-CV-2234

H(WMC), 2010 WL 5585509, at *2 (S.D.Cal. October 14, 2010) (quoting SanDisk Corp. v.

Memorex Prods., Inc., 415 F.3d 1278, 1287 (Fed.Cir. 2005)). Here, the statements made

concerning the Clark reference and withdrawn claim 22 are subject to more than one

reasonable interpretation.

Based on the foregoing, the court will construe “proximate an inhalation flow path”

as “close to or within the entrance to the mouth and/or the nasal passages and not on the

bridge of the nose.”

Plaintiffs define “engaging the carrier to a surface of the skin” as “bringing the vehicle

into contact with the skin.” Defendants’ proposed definition is “adhering to the surface of the

skin.”

Defendants contend that their construction is consistent with the ordinary meaning of

“engaging.” (Doc. 85 at 15.) They also argue that the patentee surrendered all non-adhesive

claims during prosecution of the Patent—specifically, “embodiments using deformable

members or clips to position the device in the nasal cavities.” (Doc. 89 at 15.)

As described above, the Court finds there was no disclaimer related to embodiments

of the vehicle inserted into the nose. The Court also finds, as discussed in more detail below,

that there was no disclaimer of embodiments using deformable members or clips. The

specification disclosed a clamp and a deformable element that could be used to keep the

vehicle in contact with the skin. The Court concludes, therefore, that Defendants’ proposed

construction of “adhering to the surface of the skin” is too narrow and improperly limits the

scope of the claim. See Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294, 1301

(Fed.Cir. 2003) (“Absent a clear disclaimer of particular subject matter, the fact that the

inventor anticipated that the invention may be used in a particular manner does not limit the

scope to that narrow context.”).

However, the Court agrees with Defendants that Plaintiffs’ construction—“bringing

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 14 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

1

 This construction is supported by dictionary definitions of the words engage, adhere,

and attached. Engage is defined as “to come together and interlock.” Adhere: “to hold fast

or stick by or as if by gluing, suction, grasping, or fusing.” Attach: “to make fast (as by tying

or gluing).” Merriam-Webster’s Collegiate Dictionary (11th ed. 2008). 

- 15 -

the vehicle into contact with the skin”—is imprecise. In every embodiment described, the

vehicle is attached to, not merely brought into contact with, the skin, whether by an adhesive,

a clamp, or a deformable element. Therefore, the Court will construe “engaging the carrier

to a surface of the skin” as “attaching the vehicle to the skin.”1

The parties agree that “means for engaging the carrier to the surface of the skin” is a

“means-plus-function” term governed by 35 U.S.C. § 112(f). Construction of a means-plusfunction limitation involves two steps. Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc.,

296 F.3d 1106, 1113 (Fed.Cir. 2002). First, the court must identify the claimed function. Id.

The court must construe the function to include the limitations contained in the claim

language, and only those limitations. Id. It is improper to narrow the scope of the function

beyond the claim language, or to broaden the scope of the claimed function by ignoring clear

limitations in the claim language. Id.

After identifying the claimed function, the court must determine what structure, if any,

disclosed in the specification corresponds to the claimed function. Id. In order to qualify as

corresponding, the structure must not only perform the claimed function, but the specification

must clearly associate the structure with performance of the function. Id. To determine the

structures, the court must “consider the specification as a whole, and to read all portions of

the written description, if possible, in a manner that renders the patent internally consistent.”

Budde v. Harley–Davidson, Inc., 250 F.3d 1369, 1379–80 (Fed.Cir. 2001). “[P]roper

construction should account for ‘all structures in the specification corresponding to the

claimed function’ and it would be error to limit the structure to be just the preferred

embodiment.” Seirus, 2010 WL 5585509, at *2 (quoting Callicrate v. Wadsworth Mfg., Inc.,

427 F.3d 1361, 1369 (Fed.Cir. 2005)). 

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 15 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 16 -

The means-plus-function limitation covers both distinct and alternative structures.

Creo Prods., Inc. v. Presstek, Inc., 305 F.3d 1337, 1345 (Fed.Cir. 2002). Additionally,

“[w]hen multiple embodiments in the specification correspond to the claimed function,

proper application of § 112[] generally reads the claim element to embrace each of those

embodiments.” Micro Chemical, Inc. v. Great Plains Chemical Co., Inc., 194 F.3d 1250,

1258–59 (Fed.Cir. 1999).

Plaintiffs’ proposed construction of function is “bringing the vehicle into contact with

the skin.” Defendants propose “attaching the carrier to the surface of the skin proximate an

inhalation flow path.” Neither construction is satisfactory. As Plaintiffs note, Defendants’

proposed construction, which describes the function as attaching the carrier to the surface of

the skin, is inconsistent with the claim language: “means for engaging the carrier to a surface

of skin proximate an inhalation flow path of the respiratory organ with the barrier adapted

to be interposed between the carrier and the surface of skin.” (Doc. 59, Ex. A, col. 8, ll.

37–42). Thus, while the vehicle comes into contact with the skin, the barrier is designed to

be interposed between the carrier and the skin. Contrary to Defendants’ proposed

construction, therefore, there is no requirement that the carrier itself must come into contact

with the skin. Next, for the reasons discussed above, Plaintiff’s description of function as

bringing the vehicle “into contact with” the skin is imprecise. Accordingly, the Court will

construe the function as “attaching the vehicle to the skin proximate an inhalation flow path.”

For the corresponding structure, Plaintiffs propose “adhesive, clamp, deformable

element, deformable member, and equivalents thereof,” while Defendants propose “adhesive

and equivalents thereof that were not disclaimed in prosecution.” Plaintiffs argue that their

construction is supported by the claims and specification. The Court agrees. Dependent

claims of the Patent provide that the means include an “adhesive” (claim 13), “a deformable

element” (claim 15), and “a clip” (claim 16). Similarly, the specification provides that:

user 21 may then engage adhesive backing 33 to his or her body proximate one

or more of inhalation flow paths 24 and 25 such as, as shown in FIG. 1,

adjacent the external openings of the nasal passages of nose 23. 

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 16 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 17 -

Deformable member 55 thus permits the clamping of vehicle 50 against not

only septum 56, but also to the external sidewalls 57 and 58 of nose bounding

the external openings into the nasal passages if so desired.

Clamp 61 permits the clipping engagement of vehicle 50 against, for instance,

one of at least the septum and external sidewalls bounding the external

openings of the nasal passages of the nose of a user. 

(Doc. 59, Ex. A, col. 3, ll. 41–44; col. 4, ll. 20–25, 49–52.)

Defendants again seek to limit the corresponding structure to “adhesive.” The Court

has rejected Defendants’ argument that the applicant surrendered the all non-adhesive

structures encompassed by the disputed “means for” claim language.

Defendants argue that the patentee failed to “clearly link” certain structures with the

claimed function. (Doc. 85 at 17.) Specifically, they argue that the patentee does not clearly

state that the clip and deformable element are for “engaging the vehicle to the skin proximate

an inhalation flow path.” Defendants cite, for example, the patentee’s statement that the

structures are for clamping or clipping “of vehicle 50 against not only septum 56, but also

to the external sidewalls 57 and 58 of nose bounding the external openings into the nasal

passages if so desired.” (Doc. 59, Ex. A, col. 4, ll. 20–25, 49–52; see FIG. 4 & 5.). According

to Defendants, therefore, the structures do not engage the vehicle to the skin proximate an

inhalation flow path, and this failure “to clearly associate the structures with the function

results in those structures not being covered by means-plus-function claiming.” (Doc. 89 at

17.)

The Court disagrees. Having rejected Defendants’ contention that Plaintiffs

disclaimed embodiments inserted into the nose, and having construed “proximate an

inhalation flow path” as “close to or within the entrance to the . . . nasal passages . . . ,” the

Court finds that the clip and deformable element do engage the vehicle to the skin proximate

an inhalation flow path.

Accordingly, “[a]fter considering the specification as a whole and reading the written

description in a manner that renders the patent internally consistent,” Budde, 250 F.3d at

1379–80, the Court concludes that the specification and claim history clearly link or associate

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 17 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

2

 In Seirus, the court construed terms for a patented ski mask and scarf, including the

term “securing means.” 2010 WL 5585509, at *7. The court noted that, “The specification

discloses that ‘a variety of snaps, strings, or other fastening devices’ may be used as a

securing means. The specification further discloses that co-acting fasteners, such as

VELCRO, can be used as a securing means in a preferred embodiment.” Id. The court

therefore defined securing means” to be these identified structures—namely, snaps, strings,

co-acting fasteners, and other fastening devices. Id., at *7 

- 18 -

the deformable element and clip to the function attaching the vehicle to the skin. See Omega,

334 F.3d at 1322; see also Seirus, 2010 WL 5585509, at *2.2

 The Court will construe

structure to include the embodiments disclosed in the specification: adhesive, clamp,

deformable element, or deformable member. 

IV. Conclusion

For the foregoing reasons, the Court construes the disputed claim terms as set forth

above.

IT IS SO ORDERED.

DATED this 23rd day of July, 2013.

Case 2:12-cv-02110-PGR Document 102 Filed 07/24/13 Page 18 of 18