Ex parte Galdonik

• Docket Number: Appeal 2023-001211,Application 16/699,563,Technology Center 3600
• Decision Date: 26 January 2024
• Parties: Ex parte JASON A. GALDONIK, EDWARD J. ANDERSON, KAVITHA GANESAN, GREG BOLDENOW, JOHN KIRCHGESSNER, and GRAZYNA WLODARSKI
• Court: Patent Trial and Appeal Board

1

Ex parte JASON A. GALDONIK, EDWARD J. ANDERSON, KAVITHA GANESAN, GREG BOLDENOW, JOHN KIRCHGESSNER, and GRAZYNA WLODARSKI

Appeal 2023-001211

Application 16/699,563

Technology Center 3600

United States Patent and Trademark Office, Patent Trial and Appeal Board

January 26, 2024

FILING DATE: 11/30/2019

Before MICHELLE R. OSINSKI, WILLIAM A. CAPP, and LEE L. STEPINA Administrative Patent Judges.

DECISION ON APPEAL

OSINSKI, ADMINISTRATIVE PATENT JUDGE.

STATEMENT OF THE CASE

Appellant^[1] appeals under 35 U.S.C § 134(a) from the Examiner's decision rejecting claims 1-15, 17-23, 29, 30, and 32-35. Non-Final Act. 1. Claims 16, 24-28, and 31 are cancelled. Appeal Br. 45, 46 (Claims App.). We have jurisdiction over the appeal under 35 U.S.C. § 6(b).

We AFFIRM IN PART.

THE CLAIMED SUBJECT MATTER

Claims 1 and 29 are independent. Claim 1 is reproduced below.

1. An aspiration catheter comprising

a proximal portion,

a connection port connected to the proximal portion, wherein the connection port is connected to an aspiration device,

a distal segment, and

a tube section connected between the distal segment and the proximal portion, wherein the distal segment comprises a single lumen and has a constant, non-extendable outer diameter from 0.045 inches to 0.120 inches and from 25 percent to 95 percent of the average outer diameter of the tube section and comprises a distal opening at the distal end of the catheter, and,

wherein the catheter comprises a continuous lumen extending from the proximal portion through the tube section and the distal segment to the distal opening that provides fluid communication between the proximal portion and the distal opening and

wherein the portion of the continuous lumen inside the distal segment has a smaller diameter relative to the diameter of the portion of the continuous lumen inside the tube section.

Appeal Br. 43 (Claims App.).

REFERENCES

The prior art relied upon by the Examiner is:

Name

Reference

Date

Greff

US 5,520,668

May 28, 1996

Chiang

US 5,899,890

May 4, 1999

Ha

US 6,159,195

Dec. 12, 2000

von Hoffmann

US 7,309,334 B2

Dec. 18, 2007

THE REJECTIONS

The rejections before us on appeal are:

Claim(s) Rejected

35 U.S.C. §

Reference(s)/ Basis

1-15, 17-23, 32-35

112

Written Description

1-11, 13, 15, 17-23, 32-35

103(a)

Chiang, von Hoffmann

12, 14

103(a)

Chiang, von Hoffmann, Ha

29, 30

103(a)

Chiang, von Hoffmann, Greff

OPINION

Rejection I

Written Description

Independent claim 1 recites that the distal segment of the aspiration catheter "has a constant, non-extendable outer diameter." Appeal Br. 43 (Claims App.). The Examiner finds that "the limitation'non-extendable outer diameter' is not present in the original specification." Non-Final Act. 3. The Examiner further finds that "[t]he disclosure appears silent regarding 'expansion' or 'extension' of'the distal end.'" Id. at 3-4 (citing Spec. Fig. 20). The Examiner determines that the claims, thus, contain subject matter which was not described in the Specification in such a way as to reasonably convey that that Appellant had possession of the claimed invention. Id. at 3.

Whether a specification complies with the written description requirement of 35 U.S.C. § 112 is a question of fact and is assessed on a case-by-case basis. See, e.g., Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed Cir. 2000) (citing Vas-Cathlnc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991)). The disclosure, as originally filed, need not literally describe the claimed subject matter (i.e., using the same terms or in haec verba) in order to satisfy the written description requirement. The specification, however, must convey with reasonable clarity to those skilled in the art that, as of the filing date, Appellant was in possession of the claimed invention. See id.

Appellant asserts that "[c]laim construction underlies any analysis of rejections," and we agree. Appeal Br. 15. Appellant takes the position that "non-extendable generally refers to catheters maintaining their basic structure during use following delivery into a patient and would be understood by a person of skill in the art (i.e., an experienced medical device engineer) as describing the state of the distal segment during aspiration." Id. at 16-17.

Because the term "non-extendable" is not used in the Specification, we look to its ordinary and customary meaning. We first consult a general dictionary definition for the word "extendable" for guidance in determining the ordinary meaning of the term as viewed by a person of ordinary skill in the art. See 37 C.F.R. § 41.30; Comaper Corp. v. Antec, Inc., 596 F.3d 1343, 1348 (Fed. Cir. 2010) (approving of "consult[ing] a general dictionary definition of [a] world for guidance" in determining ordinary meaning); Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306, 1325 (Fed. Cir. 2008) ("[0]ur decisions, including Phillips [v.AWH Corp.], 415 F.3d [1303,] 1322 [(Fed. Cir. 2005)], do not preclude the use of general dictionary definitions as an aid to claim construction."). "Extendable" is defined as "[c]apable of being extended or stretched out; capable of being enlarged in length, area." Oxford English Dictionary (2023). Accordingly, "non-extendable" is defined as not having such capability. We find nothing in the Specification inconsistent with this ordinary meaning. See In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989) (the words of the claim must be given their plain meaning unless the plain meaning is inconsistent with the Specification). In the context of claim 1, in which it is the "outer diameter" of the distal segment of the aspiration catheter that is non-extendable, we construe the claim to require the distal segment's outer diameter to not be capable of being extended or stretched out or enlarged.

"Negative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation." Santarus, Inc. v. ParPharm., Inc., 694 F.3d 1344, 1351 (Fed. Cir. 2012). A reason to exclude an element may be found in "statements in the specification expressly listing the disadvantages of using" that element. Id. Additionally, another reason to exclude may be when the specification "distinguishes among" the element and alternatives to it. Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1357 (Fed. Cir. 2015). Our reviewing court further notes that "it is possible that the written description requirement may be satisfied when a skilled artisan would understand the specification as inherently disclosing the negative limitation." Novartis Pharm. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 1017 (Fed. Cir. 2022) (emphasis added, footnote omitted); see also id. at 1020 ("While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure.").

Appellant suggests that "[i]f there is no aspiration catheter described in Appellant's specification having a distal segment with an extendable outer diameter, it only logically follows that what is described is an aspiration catheter having a non-extendable outer diameter at the distal segment."

Appeal Br. 17. Appellant continues that "[t]he feature at issue (non-extendable) is simply a description of what is clearly taught already in Appellant's specification for all of their embodiments" and "[t]his fact would be clearly recognized by a person of ordinary skill in the art." Id. at 18. Such argument is not persuasive in light of the standard for adequately supporting negative claim limitations, which requires something beyond silence. See Santarus, 694 F.3d at 1351.

Appellant next asserts that

Medical catheters generally are formed with significant flexibility with respect to deflection relative to the central axis of the catheter but, for application similar to those used here, with appropriately strong catheter walls to avoid punctures, kinking, collapse or the like that could negatively impact performance during a medical procedure. It is known that thermoplastic polymers with optional wire reinforcement generally meet these requirements, and Appellant's specification describes thermoplastic polymers as a suitable material for the catheters and optional wire reinforcement. See, for example, paragraph [0123] of the specification. Such structures are radially inelastic relative to the central axis of the catheter, and would clearly be recognized as such due to the nature of the materials.

Appeal Br. 18-19.

We do not agree that Appellant has provided sufficient technical reasoning or evidence, merely by pointing to the disclosure of a catheter comprising a thermoplastic polymer with optional wire reinforcement (Appeal Br. 18-19 (citing Spec. 36:21-22)), to conclude that a person of ordinary skill in the art would understand that the catheter necessarily has a non-extendable outer diameter. In other words, we do not agree that a person of ordinary skill in the art would understand the claimed negative limitation at issue to be present necessarily in at least one embodiment in the disclosure. See Novartis, 38 F.4th at 1017.

We have also considered Appellant's arguments that it "would be understood by a medical device engineer that an aspiration catheter having an extended diameter during aspiration would . . . require an explicit structure to actuate and maintain the extended diameter since the naturally applied forced would collapse, not extend, the diameter." Appeal Br 19; see also id. at 20 ("based on . . . physical laws and material properties well known in the art at the time of filing,... the outer diameter of the distal segment of a catheter will not...