Ex Parte Kurtz et alDownload PDFPatent Trial and Appeal BoardApr 26, 201811469899 (P.T.A.B. Apr. 26, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 111469,899 0910512006 Ronald M. Kurtz 33357 7590 04/30/2018 JOHNSON & JOHNSON SURGICAL VISION, INC. 1700 E. ST. ANDREW PLACE SANTA ANA, CA 92705 UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. JSV6095USNP (70054-74USO) CONFIRMATION NO. 7182 EXAMINER SHAY,DAVIDM ART UNIT PAPER NUMBER 3769 NOTIFICATION DATE DELIVERY MODE 04/30/2018 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address( es): JNJUSPatent@corus.jnj.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RONALD M. KURTZ, TIBOR JUHASZ, MELVIN A. SARA YBA, and ROGER STEINERT Appeal 2016-002216 1 Application 11/469,8992 Technology Center 3700 Before KENNETH G. SCHOPPER, BRADLEY B. BAY AT, and AMEE A. SHAH, Administrative Patent Judges. BAY AT, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. § 134(a) from the Final Rejection of claims 16, 20, 22, and 30-33 (App. Br. 6; Reply Br. 3). 3 We have jurisdiction under 35 U.S.C. § 6(b). A hearing was held on March 19, 2018, a transcript of which has been entered into the record ("Tr."). 1 Our Decision references Appellants' Appeal Brief ("App. Br.," filed May 20, 2015), Reply Brief ("Reply Br.," filed Dec. 18, 2015), the Examiner's Answer ("Ans.," mailed Oct. 22, 2015), and Final Office Action ("Final Act.," mailed Jan. 21, 2015). 2 Appellants identify "Abbott Medical Optics Inc." as the real party in interest. App. Br. 2. 3 We note Appellants' incorrect citation to "US Patent No. 6,110,016" as referencing Juhasz, which is US 6, 110, 166. Appeal2016-002216 Application 11/469,899 SUMMARY OF DECISION We REVERSE and enter a NEW GROUND OF REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b). CLAIMED SUBJECT MATTER Method claims 16 and 33 are the only independent claims on appeal. Claim 16, reproduced below, is illustrative of the subject matter on appeal. 16. A method of transplanting donor tissue from a donor cornea to a recipient cornea, the method comprising: determining a first incision depth from an anterior corneal surface; determining a second incision depth from the anterior corneal surface, wherein the second incision depth is greater than the first incision depth; placing a contact lens against the anterior corneal surface of each of the recipient cornea and the donor cornea, wherein the contact lens is adapted to conform the anterior corneal surface to a shape of the contact lens; making a resection incision at the first incision depth in each of the donor cornea and the recipient cornea; making an annular incision at the second incision depth in each of the donor cornea and the recipient cornea, the annular incision having an outer periphery and an inner periphery, wherein corneal tissue within the inner periphery and outside of the outer periphery remains intact after the annular incision is made; making a first sidecut incision in each of the donor cornea and the recipient cornea, the first sidecut incision running from the outer periphery of the annular incision to one of a posterior corneal surface or the resection incision, wherein the first sidecut incision forms a first acute angle with the annular incision; making a second sidecut incision in each of the donor cornea and the recipient cornea, the second sidecut incision running from the inner periphery of the annular incision to the other of the posterior corneal surface or the resection incision, 2 Appeal2016-002216 Application 11/469,899 the first sidecut and second sidecut incisions being offset from each other with the annular incision extending therebetween, wherein the second sidecut incision forms a second acute angle with the annular incision, and wherein a combination of the incisions in each of the recipient cornea and the donor cornea resects corneal tissue from the recipient cornea and resects the donor tissue from the donor cornea, respectively; and grafting the donor tissue into the recipient cornea, engagement of incised surfaces of the donor tissue with incised surfaces of the recipient cornea securing the donor tissue into the recipient cornea sufficiently that sutures are not used, wherein the incisions are made using a surgical laser, and wherein the annular incision is at a uniform distance from the posterior corneal surface. App. Br. 13-14 (Claims Appendix) (emphasis added). REJECTIONS I. Claims 16, 20, 22, and 30-32 are rejected under 35 U.S.C. § 103(a) as unpatentable over Sarayba,4 Juhasz, 5 White, 6 and Lai. 7 II. Claim 33 is rejected under 35 U.S.C. § 103(a) as unpatentable over Sarayba, Juhasz, White, Lai, and Stojkovic. 8 4 Sarayba et al., Femtosecond Laser Posterior Lamellar Keratoplasty: A Laboratory Model Cornea 328-333 (2005) (Sarayba). 5 Juhasz, US 6,110,166, issued Aug. 29, 2000. 6 White, US 4,772,283, issued Sept. 20, 1988. 7 Lai, US 5,549,632, issued Aug. 27, 1996. 8 Stojkovic et al., Corneal Shrinkage Induced by Nonmechanical Q-switched Erbium: YAG Laser Trephinationfor Penetrating Keratoplasty in Porcine Eyes Graefes Arch Clin Exp Ophthalmol. 667----672 (2003) (Stojkovic ). 3 Appeal2016-002216 Application 11/469,899 ANALYSIS As set forth below, pursuant to our authority under 37 C.F.R. § 41.50(b), we enter a new ground of rejection of claims 16, 20, 22, and 30- 33 under 35 U.S.C. § 112, second paragraph, as being indefinite. In light of this new rejection, it would be premature to reach the merits of the rejections under 35 U.S.C. § 103(a) at this time. Before a proper review of the rejections under§ 103(a) can be made, the subject matter encompassed by the claims on appeal must be reasonably understood without resort to speculation. Because the claims fail to satisfy the requirements under 35 U.S.C. § 112, second paragraph, we are constrained to reverse, proforma, the Examiner's rejections under 35 U.S.C. § 103(a). See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (A prior art rejection cannot be sustained if the hypothetical person of ordinary skill in the art would have to make speculative assumptions concerning the meaning of claim language). It should be understood that our decision to reverse the rejections of claims 16, 20, 22, and 30-33 under 35 U.S.C. § 103(a) is based solely on the indefiniteness of the claims, and does not reflect on the merits of the underlying rejections. New Ground of Re} ection-Jndefiniteness In determining whether a claim is definite under 35 U.S.C. § 112, second paragraph, "[t]he USPTO, in examining an application, is obliged to test the claims for reasonable precision." In re Packard, 751F.3d1307, 1313 (Fed. Cir. 2014 ). "[A] claim is indefinite when it contains words or phrases whose meaning is unclear." Id. at 1322; Ex Parte McAward, No. 4 Appeal2016-002216 Application 11/469,899 2015-006416, 11 (PTAB Aug. 25, 2017) (precedential) (quoting In re Packard, 751 F.3d at 1314). The Office "determines the scope of claims ... not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction 'in light of the specification as it would be interpreted by one of ordinary skill in the art."' Phillips v. A WH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en bane) (quoting Jn re Am. Acad. Of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). During examination, an applicant must "clearly and precisely set out the metes and bounds of the claimed [subject matter]." See Ex parte Miyazaki, 89 USPQ2d 1207, 1211- 13 (BP AI 2008) (precedential) (holding that "if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite."). "The present invention is directed toward [] a method for resecting corneal tissue as part of a transplant procedure." Spec. i-f 4. The final "grafting" step performed in each of independent claims 16 and 33, which appears central to the Appellants' argument against the art rejections (see, e.g., App. Br. 8-11; Reply Br. 7-10; Tr. 3-12, 15-18), recites the step of "grafting the donor tissue into the recipient cornea, engagement of incised surfaces of the donor tissue with incised surfaces of the recipient cornea securing the donor tissue into the recipient cornea sufficiently that sutures are not used." App. Br. 14, 16 (Claims Appendix). The Appellants interpret the non-use of sutures as recited in the "grafting" step of the claims as encompassing the whole transplant 5 Appeal2016-002216 Application 11/469,899 procedure because "one of ordinary skill in the art, having read Applicants' Specification, would have reasonably and properly concluded that the claimed methods include entirely sutureless procedures, such as sutureless PLK methods." Reply Br. 8; see also App. Br. 8. In support of this interpretation, the Appellants assert that "[ t ]he preambles of independent claims 16 and 33 are directed to a 'method of transplanting donor tissue from a donor cornea to a recipient cornea' and a 'method for performing partial thickness transplant,' respectively ... [which] refer to the entire complete 'transplant' procedure, and not merely a selected portion thereof." Reply Br. 8. According to the Appellants, "the Specification teaches that the use of sutures is optional: 'Following the graft, the donor tissue may be secured using a plurality of sutures, each preferably passing through the sidecut incision which is nearest the posterior surface of the recipient cornea,' ... [thus,] the use of the permissive 'may' indicates that sutures may or may not be used." Id. (quoting Spec. i-f 5). The Appellants assert that the statement: "[i]n a PLK procedure, sutures are not necessary to secure the donor tissue to the recipient cornea" (Spec. i-f 17), "clearly refers to the entirety of the PLK procedure and not merely a subset of incision directed to forming a graft." Id. at 9. Finally, in support of their interpretation, the Appellants refer to the originally filed independent claims, which are "silent as to the requirement of sutures," but are further limited by the dependent claims, which require "securing the donor tissue to the recipient cornea with a plurality of sutures." Id. at 8. The Examiner states that none of the incisions discussed in the Specification relate to the opening up of the cornea to provide access to 6 Appeal2016-002216 Application 11/469,899 remove and replace the recipient and donor tissue as part of the PLK procedure. Ans. 9. According to the Examiner, "it is clear that the originally filed disclosure does not provide support for the scope of the claims which appellant is relying on for patentability" (id.), and, therefore, the Examiner has interpreted the non-use of sutures as recited in the claims to be limited to grafting the donor tissue into the recipient cornea, rather than an entirely suture-less procedure. The majority of the discussion during oral hearing involved the Appellants' and the Examiner's differing interpretations as to the "grafting" step of claims 16 and 33. See Tr. 3-12, 15-18. Appellants' counsel acknowledged the "two competing interpretations" (Tr. 4:7; see also id. at 6: 15-19 ("Does it encompass both the grafting step and the closing step or the opening step or maybe other pre or post steps ... I admit there are two different interpretations.")), and framed the issue as one of claim breadth. According to Appellants, "the narrower interpretation would require non-use of sutures for the grafting as well as the non-use of sutures in the entire procedure which include the axis opening, or closing of the axis opening," and "[t]he [E]xaminer's interpretation is a broader one, and that says that the claim element required non-use of sutures for the grafting part but places no restriction on whether sutures could be used elsewhere." Id. at 4: 10-17. We do not agree that the issue before us is one of claim breadth, because that would require the scope of the claimed subject matter to be clearly defined. Instead, we determine that claims 16 and 33 are indefinite because the boundaries of the protected subject matter are not clearly delineated and the scope is unclear. It is unclear how one of ordinary skill in 7 Appeal2016-002216 Application 11/469,899 the art would understand the scope of "grafting the donor tissue into the recipient cornea, engagement of incised surfaces of the donor tissue with incised surfaces of the recipient cornea securing the donor tissue into the recipient cornea sufficiently that sutures are not used" (App. Br. 14, 16 (Claims Appendix with added emphasis)), when interpreted in light of the Specification. We acknowledge that relative terms do not automatically render a patent claim indefinite; however, the use of relative terms in a claim must be evaluated on a case-by-case basis, the acceptability of which is determined based on whether an artisan would understand the scope of the claim when read in light of the specification. \Vhen a term of degree such as sufficiently9 is used as recited in claims 16 and 33, the Specification must provide some objective standard for measuring that degree. See Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350-55 (Fed. Cir. 2005). The term sufficiently neither appears in the Specification, nor is any standard provided for measuring the requisite degree of engagement of the incised surfaces of the donor tissue with the incised surfaces of the recipient cornea to secure the donor tissue into the recipient cornea without sutures. In other words, the determination of what is considered sufficient engagement of the incised surfaces so that sutures need not be used is subjective, and completely dependent on a person's subjective opinion. "The scope of claim language cannot depend solely on the unrestrained, subjective opinion of a particular individual purportedly 9 Defined as: "to the degree that is needed for a particular purpose." https://www.macmillandictionary.com/us/ dictionary/ american/ sufficiently (last visited April 23, 2018). 8 Appeal2016-002216 Application 11/469,899 practicing the invention." See id. at 1350 (citations omitted). One of ordinary skill in the art would not understand the requisite degree of engagement needed between the incised surfaces of the donor tissue and recipient con1ea so that sutures are not needed to either graft the donor tissue into the recipient cornea, or, to perfonn the entire corneal transplant procedure without sutures. This lack of clarity is underscored in that the difference between the use and non-use of sutures appears essential to how substantially engaged the incised surfaces of the donor tissue is to the recipient cornea. For example, in comparing the lamellar keratoplasty 10 procedures of the anterior surface of the cornea (ALK procedure) to the posterior surface of the cornea (PLK procedure), the Specification discloses that in an ALK procedure "donor tissue may be secured to the recipient cornea by either of the [suturing] techniques described" (Spec. i-f 16), and that "[i]n a PLK procedure, sutures are not necessary to secure the donor tissue to the recipient cornea." Spec. i-f 17. In distinguishing the prior art's disclosure of a PLK procedure from the above statement, the Appellants' counsel asserted: "one important feature of our innovation is to use the Z-shaped side-cut, and because of that we are able to avoid the use of sutures - in the grafting step. That's actually why the claim language reads the way it does. It's the fitting." Tr. 7:21-24; id. at 8: 16-17 ("there's the interlocking aspect 10 "Transplantation of donated corneal tissue into the middle layers of the cornea, leaving the corneal endothelium and inner layers of the cornea intact." https://medical- di cti onary. thefreedi cti onary. com/lamellar+ keratop lasty (last visited April 23, 2018). 9 Appeal2016-002216 Application 11/469,899 of the [Z-shaped] side cut that make it more secure."). When asked where the Specification describes the lack of sutures as being the result of the Z- shaped cut, the Appellants could only direct us to Figure 4. See Tr. 8: 1-11. But Figure 4 does not demonstrate such a nexus, especially in comparison to Figure 3, in which a similar Z-shaped cut is shown as part of an ALK procedure, wherein sutures are placed to secure the donor tissue to the recipient cornea. cf Spec., Figs. 3 and 4. Therefore, the distinction between the use and non-use of sutures is in part dependent on the degree to which the incised surfaces of the donor tissue is engaged with the recipient cornea to create the requisite "fitting" so that sutures are not used. On the one hand, Appellants argue that the claims are directed to an entirely suture-less corneal transplant procedure "includ[ing] the axis opening, [and] closing of the axis opening" (Tr. 4: 11-12), and on the other hand, Appellants admit that "[ t ]he [axis] opening is actually not mentioned in our disclosure ... [because w ]e focused on the shape of the side cut and the grafting part" (id. at 5:18-20). As such, one skilled in the art reading Appellants' Specification is left to consult the subjective opinion of ophthalmologists to determine what degree of engagement of the incised surfaces of the donor tissue with the recipient cornea is sufficient, so that sutures are not required to secure the graft, or not required for any other part of the corneal transplant procedure (i.e., axis opening). Having considered this claim language in the context of the circumstances, we determine the term "sufficiently that sutures are not used" renders the claims indefinite because they are susceptible to at least two equally reasonable interpretations, in the absence of any objective 10 Appeal2016-002216 Application 11/469,899 standard or description. The Miyazaki standard for evaluating indefiniteness is justified, at least in part, because applicants have the opportunity and the obligation to define the invention precisely during prosecution before the US Patent & Trademark Office. See Miyazaki, 89 USPQ2d at 1215. Section 112 places the burden of precise claim drafting on applicants. See Packard, 751 F.3d at 1313 ("Given the role of the applicant in the process, it is a reasonable implementation of the examination responsibility, as applied to § 112[, second paragraph], for the [Office], upon providing the applicant a well-grounded identification of clarity problems, to demand persuasive responses on pain of rejection."). Accordingly, we enter a New Ground of Rejection of independent claim 16 and 33 as indefinite under 35 U.S.C. § 112, second paragraph, including claims 20, 22, and 30-32 dependent thereon. DECISION The Examiner's prior art rejections of claims 16, 20, 22, and 30-33 are reversed proforma. A NEW GROUND OF REJECTION is entered for claims 16, 20, 22, and 30-33 as indefinite under 35 U.S.C. § 112, second paragraph. Section 41.50(b) provides that "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." Thus, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, Appellants must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the newly rejected claims: 11 Appeal2016-002216 Application 11/469,899 ( 1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the Examiner; or (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). REVERSED; 37 C.F.R. § 41.50(b) 12 Copy with citationCopy as parenthetical citation