Ex parte Peyman

• Decision Date: 29 May 2015
• Docket Number: Appeal 2015-002417
• Parties: Ex parte GHOLAM A. PEYMAN Application No. 12/770, 011 Technology Center 3700
• Court: Patent Trial and Appeal Board

Ex parte GHOLAM A. PEYMAN Application No. 12/770, 011 Technology Center 3700

Appeal No. 2015-002417

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

May 29, 2015

FILING DATE 04/29/2010

Before CHARLES N. GREENHUT, LYNNE H. BROWNE, and JILL D. HILL Administrative Patent Judges.

DECISION ON APPEAL

GREENHUT, Administrative Patent Judge.

STATEMENT OF CASE

Appellant appeals under 35 U.S.C. § 134 from a rejection of claims 1, 7, 9, 10, 17 and 19-28. Non-Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b).

We affirm-in-part.

The claims are directed to a method for laser correction of refractive errors of an eye with a thin cornea. Claim 1 reproduced below, is illustrative of the claimed subject matter:

1. A method of altering the refractive properties of the eye, said method comprising:

forming a flap in a thin cornea that has a thickness of less than 480 microns, so as to expose one of the stroma and the Bowman's Layer of an eye;

after forming the flap in the thin cornea, applying a liquid suspension having nano particles of riboflavin to the one of the stroma and the Bowman's Layer of the eye, the nano particles facilitating cross linking of the one of the stroma and the Bowman's Layer of the thin cornea;

irradiating the thin cornea with at least one of ultraviolet light and microwaves so as to activate cross linkers in the thin cornea and thereby stiffen the thin cornea and prevent corneal ectasia in the thin cornea; and

after the thin cornea has been stiffened by the activation of the cross-linkers, ablating a portion of the thin cornea underlying the flap so as to change the refractive properties of the eye.

REFERENCES

The prior art relied upon by the Examiner in rejecting the claims on appeal is:

L'Esperance

US 4, 665, 913

May 19, 1987

Warner

US 4, 903, 695

Feb. 27, 1990

Peyman '748

US 5, 964, 748

Oct. 12, 1999

Karageozian

US 6, 537, 545 B1

Mar. 25, 2003

Peyman '307

US 6, 551, 307 B2

Apr. 22, 2003

Peyman '374

US 7, 001, 374 B2

Feb. 21, 2006

Luce

US 7, 004, 902 B2

Feb. 28, 2006

Sand

US 7, 044, 945 B2

May 16, 2006

Akiyama

US 2007/0135754 A1

June 14, 2007

Kochevar

WO 01/58495 A2

Aug. 16, 2001

Gregor Wollensak, MD, et al., Riboflavin/Ultraviolet -A-induced Collagen Crosslinkingfor the Treatment of Keratoconus, Am J Ophthalmol 2003; 135: 620-627 (2003) (hereinafter "Wollensak").

REJECTIONS

A. Claims 1, 7, 9, 10, 17, 19, 22-25, and 28 under 35 U.S.C § 103(a) as being unpatentable over Wollensak, Akiyama, Sand, Karageozian, Peyman '748, L'Esperance, and Warner. Non-Final Act. 8.

B. Claims 1, 7, 17, and 19 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, and Peyman '374. Non-Final Act. 9.

C. Claims 17 and 19 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, and Luce. Non-Final Act. 10.

D. Claims 1, 7, 17, 19, 22, 23, 25, and 28 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, Peyman '374, and Kochevar. Non-Final Act. 11-12.

E. Claims 17, 19, 22, 23, 25, and 28 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, and Luce.^[1] Non-Final Act. 12.

F. Claim 9 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, Peyman '374, and L'Esperance. Non-Final Act. 13.

G. Claims 9 and 24 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, Peyman '374, Kochevar, and L'Esperance. Non-Final Act. 14.

H. Claim 10 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, Peyman '374, L'Esperance, and Warner. Non-Final Act. 14.

I. Claim 10 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, Peyman '374, Kochevar, L'Esperance, and Warner. Non-Final Act. 14.

J. Claims 20, 21, 26, and 27 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, Sand, Karageozian, Peyman '748, L'Esperance, Warner, and Peyman '307. Non-Final Act. 15.

K. Claims 20, 21, 26, and 27 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, Peyman '374, and Peyman '307. Non-Final Act. 15.

L. Claims 20 and 21 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, Luce, and Peyman '307. Non-Final Act. 16.

M. Claims 20, 21, 26, and 27 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, Sand, Karageozian, Peyman '748, L'Esperance, Warner, and Peyman '307. Non-Final Act. 16.

N. Claims 20, 21, 26, and 27 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, Peyman '374, Kochevar, and Peyman '307. Non-Final Act. 17.

O. Claims 20, 21, 26, and 27 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, Luce, and Peyman '307. Non-Final Act. 17.

P. Claims 20, 21, 26, and 27 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wollensak, Akiyama, Sand, Karageozian, Peyman '748, L'Esperance, Warner, and Peyman '307. Non-Final Act. 18.

OPINION

Appellant's Invention

"[T]he normal corneal thickness is about 490-560 microns." Spec. 27, para. 148. However, "thin corneas are found often in patients who have high myopia (i.e., near sightedness). Such thin corneas, i.e., having a thickness of Id. This is due to the fact that "corneal ablation in these patients generally will lead to further thinning of the cornea, reduced stability of the cornea, and possible corneal perforation." Id.

Appellant sought to develop "a method for correcting refractive error in patients with thin corneas, e.g., Spec. 27, para 149; Figs. 41a-f. Appellant recognized that "[c]ross linking of the cornea has been recently advocated to correct the refractive problems of the eyes having these types of corneas (e.g., by the present inventor) for advanced corneal ectasia, such as in Keratoconous to stabilize the condition." Spec. 27, para 148.

The claimed methods intermingle the steps of performing refractive eye surgery with the steps of using crosslinking to stabilize ectasia. Spec. 28, para. 151.

The Prior Art

Wollensak was primarily concerned with using "[c]ollagen crosslinking [as] a new way for stopping the progression of keratectasia^[2] in patients with keratoconus." Wollensak, p. 620. To do so, Wollensak cautiously removed "[t]he central 7 mm^[3] of the corneal epithelium." Id. at 621^[4]; Non-Final Act. 3^[5]. A photosensitizer, riboflavin 0.1 % solution, was applied and irradiated (id.) followed by reepithelialization (id. at 624). After discussing the results (id.), Wollensak concluded that "collogen-crosslinking appears to be effective in stopping the progression of keratoconus" (id. at 625; Adv. Act. mailed Sept. 13, 2012). Wollensak attributed this success to a known stiffening effect which was shown to increase corneal rigidity in porcine and rabbit corneas similarly treated. Id. Wollensak goes on to suggest, albeit briefly, that "[c]ollagen crosslinking could also be useful for the treatment of iatrogenic keratectasia resulting from laser in situ keratomileusis^[6] either as prophylaxis or as postoperative treatment." Id. at 626; Non-Final Act. 4. Wollensak twice cautions against crosslinking treatment with a corneal thickness that is not at least 400 urn. Non-Final Act. Int. Sum., citing Wollensak, p. 626, para. 4; Ans. 4, citing last full paragraph of the first column of Wollensak, p. 626.

Akiyama is cited by the Examiner to support the undisputed finding that it was known to deliver riboflavin phosphate via nanoparticles. See Non-Final Act. 3, (citing Akiyama, para. 46).

Sand was concerned with, inter alia, mitigating degradation of corneal integrity due to refractive alterations. Sand, col 1, 11. 56-64. Sand is relied upon by the Examiner to support the undisputed finding that it was known to "apply [] an effective amount of a composition [that] creates or restores cross-links between stromal lamellae, where the cross-links increase the stability of the scleral stroma ... A preferred photoactivable composition is riboflavin, which is activated by heat to form cross-links." Sand, col. 3, 11. 17-24; Non-Final Act. 8.

Karageozian is relied on by the Examiner for its discussion of the corneal structure reproduced above and for the undisputed finding that it was known to employ microwaves as a mechanism by which to heat the cornea, for example to effectuate the teachings of Sand discussed above. Non-Final Act. 8; Karageozian, col. 2, 11. 48-53. We note that microwave irradiation is recited only as an alternative to ultraviolet light irradiation in a Markush-grouping. As ultraviolet light irradiation is already taught by Wollensk, which is applied in every rejection, Karageozian is superfluous in this regard. See In re SMI, 523 F.2d 1392, 1397 (CCPA 1975) (only one element of a Markush group need be shown in the prior art for that group as a whole to be considered to be known, used or described in the prior art for purposes of an obviousness analysis).

The Examiner cited L'Esperance as teaching "the use of excimer lasers to remove corneal tissue." Non-Final Act. 8. There does not appear to be any dispute on this point.

The Examiner cited Warner as teaching "the desirability of forming a flap when performing laser refractive surgery." Non-Final Act. 8; see, e.g., Warner, col. 5, 1. 61 et seq. Again, there does not appear to be any dispute that Warner teaches as much.

Appellant's prior patent, Peyman '748^[7], is also cited by the Examiner for the undisputed finding that it was known to form a flap in the eye and irradiating tissues therebeneath for altering the refractive properties of the cornea by ablating the tissue under the flap using an excimer laser. Non-Fi...