APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 10/748,316 12/30/2003 Jeffrey Robert Roose

Transcription

1 UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 10/748,316 12/30/2003 Jeffrey Robert Roose /02/2011 Maginot, Moore & Beck LLP Chase Tower 111 Monument Circle, Suite 3250 Indianapolis, IN EXAMINER LAURITZEN, AMANDA L ART UNIT PAPER NUMBER 3737 MAIL DATE DELIVERY MODE 11/02/2011 PAPER 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. PTOL-90A (Rev. 04/07)

2 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES Ex parte JEFFREY ROBERT ROOSE Appeal Technology Center 3700 Before: WILLIAM F. PATE, III, EDWARD A. BROWN, and WILLIAM V. SAINDON, Administrative Patent Judges. SAINDON, Administrative Patent Judge. DECISION ON APPEAL

3 STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. 134 from the Examiner s decision rejecting claims 1-15 and Br. 2. We have jurisdiction under 35 U.S.C. 6(b). Claim 1, reproduced below, is illustrative of the claimed subject matter. 1. A method for designing a surgical guide for a joint replacement prosthesis comprising: generating a bone surface image from three dimensional bone image data of a patient's bone; generating a surgical guide image from the bone surface image and an image of a prosthetic implant imposed on the bone surface image; and generating control data from the generated surgical guide image, the control data being used to control operation of a machine to fabricate a surgical guide. References The Examiner relies upon the following prior art references: Carson Lang Dore US 2002/ A1 US 2003/ A1 US 2003/ A1 Oct. 10, 2002 Nov. 20, 2003 Dec. 25, 2003 Rejections 1 I. Claims 15 and are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. II. Claim 18 is rejected under 112, first paragraph, as based on a disclosure that is not enabling. 1 The Examiner additionally objects to claim 18 and the drawings. Ans. 3. We do not have jurisdiction over objections. See In re Mindick, 371 F.2d 892, 894 (CCPA 1967). See Manual of Patent Examining Procedure (MPEP) 1002 and

4 III. Claims 1-7 and 8-14 are rejected under 103(a) as unpatentable over Lang and Dore. IV. Claims 15 and are rejected under 103(a) as unpatentable over Carson. We AFFIRM-IN-PART. SUMMARY OF DECISION OPINION Rejection I Written Description Claim 15 requires a step of determining changes in the surface of the bone using the received positional data. The Examiner found that this feature is not found in the Specification, and to the extent that using positional data to determine movement of a tip of a reference pointer is described, this does not encompass determining changes in the surface of the bone using the received positional data. Ans. 3-4 (emphasis added). Appellant argues that pages 18 and 19 of the Specification provide support for the claimed feature. Br [T]he test for sufficiency [of written description] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). This test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Id. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed. Id. This inquiry is a question of 3

5 fact. Id. (citing Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985)). The Specification states that registration module 214 receives positional data from the reference pointer 208 and correlates a position corresponding to the positional data to a point on the surface of the volumetric image. Spec. 18: Next, [a]s bone is removed, the registration module 214 determines that the surface points of the volumetric data are changing. Spec. 19: Notably, the Specification does not specify any particular manner by which the registration module 214 determines that surface points are changing. Appellant does not explain why one of ordinary skill in the art would nevertheless necessarily understand that the registration module 214 determines changes in the surface of the bone using positional data, in particular. While it may be said that if the position sent from the probe was within an area previously understood to be bone, then that portion of the bone must have been removed, the Specification does not provide any evidence that this was considered to be a part of the invention. See Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) ( it is not a question of whether one skilled in the art might be able to construct the patentee s device from the teachings of the disclosure [but] whether the application necessarily discloses that particular device ) (internal citation and quotation omitted). Accordingly, we find that the Specification, as originally filed, does not reasonably convey to one of ordinary skill in the art that the inventors had in possession at the time of invention a registration module that determines changes in the surface of the bone using received positional data from a reference pointer. Claim 21 depends from claim 15 and further requires that the registration module is configured to identify the portion of a bone 4

6 remaining to be excised as in claim 15, i.e., based upon the received positional data. The Examiner found that this feature is not described in the Specification. Ans. 4. Appellant argues that, like claim 15, the support for claim 21 is found in pages 18 and 19 of the Specification. Br As is the case for claim 15, the Specification likewise does not describe determining what portion of a bone remains to be excised based upon the received positional data. Instead, the Specification merely states that the image depicts what remains to be removed (see Spec., 19:13-16), but the Specification does not link that image with the reference pointer. Appellant does not point to any other purported errors in Rejection I. As such, we sustain the Examiner s 35 U.S.C. 112, first paragraph, rejection of claims 15 and as lacking written description. Rejection II - Enablement Claim 18 depends from claim 15 and requires that the reference pointer is an articulating arm with positional gyros mounted at pivotal joints of the articulating arm. The Examiner found that the claim does not have an enabling disclosure. Ans. 4. In particular, the Examiner found that the phraseology is not conventional in the art and the feature is not depicted in the drawings so it is therefore not enabled by the disclosure. Id. Appellant provides evidence to support their position that articulated arms and positional gyros were known in the art, and thus the claim is supported by an enabling disclosure. Br The enablement requirement seeks to assure that a person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). While the arm may not be in the drawings, if arms (as claimed) are well-known, then the arm need not be 5

7 shown in the drawings or described in any other portion of the Specification, subject to written description requirements. See Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986) ( a patent need not teach, and preferably omits, what is well known in the art. ) (citing Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick, 730 F.2d 1452, 1463 (Fed. Cir. 1984)); see also Spec. 18:11-14 (describing an articulating arm having positional gyros at each arm joint ). The Examiner does not make any findings as to whether the articulated arm would require undue experimentation to be made in the manner required by claim 18. On the other hand, Appellant has provided evidence suggesting that articulated arms are known in the art. See, e.g., Br As such, the Examiner has not shown that articulated arms are not well known in the art. The Examiner additionally finds the phraseology of claim 18 unconventional, but it is unclear as to how this, if true, would require undue experimentation to make or use the device of claim 18. Instead, the Examiner s reasoning appears to be an argument related to the definiteness requirement of 35 U.S.C. 112, second paragraph. The Examiner has not shown how it would require undue experimentation to make or use the subject matter of claim 18 because the Examiner has not shown how the subject matter of claim 18 correlates to any of the Wands factors. As such, we do not sustain Rejection II. Rejection III Obviousness in view of Land and Dore The Examiner rejects independent claims 1 and 8 as obvious in view of the Lang and Dore systems. Ans Claims 1 and 8 require, in relevant part, a step of, or system for, generating a surgical guide image from the bone surface image and an image of a prosthetic implant. The Examiner 6

8 found that Lang teaches this element of these claims. Ans. 4-5 (citing to Lang, paras. [0028], [0030]). Appellant raises the dispositive issue of whether Lang describes or suggests this element. Br. 21. The Examiner notes that surgical guide is a broad limitation that reads on various tools or models. Ans However, claims 1 and 8 specifically require that a surgical guide be generated using (1) the bone surface image and (2) the prosthetic implant image. It is the Examiner s burden to provide the factual basis showing how the Lang and Dore references render obvious the claimed surgical guide. In re Warner, 379 F.2d 1011, (CCPA 1967). Reviewing the Examiner s citations, we do not find a teaching in Lang regarding a surgical guide generated from both bone surface and prosthetic implant images. Paragraphs 28 and 30 discuss bone surface and prosthetic implant images, but do not discuss generating a surgical guide image from those images. The Examiner s position that the image itself is the surgical guide (see, e.g., Ans. 8, the anatomical models themselves being encompassed by [the] surgical guide ) is not accurate because the anatomical model is, at best, an image of the bone surface and prosthetic implant, not an image generated from those images. See, e.g., Lang, paras. [0062], [0067], [0085], [0087] (describing images of bones and ways to acquire the images), [0100]-[0103] (describing the shape of the prosthetic as determined by the shape of the bone). Lang discusses creating surgical tools from bone images at paragraph [0173] et seq., but the shape or configuration of the surgical tool is based on the image of the joint, not the image of the joint and an image of a prosthetic. The Examiner does not explain if or why it would have been obvious to modify the Lang surgical tool creation system (e.g., at paragraph [0173] et seq.) to create an image of the tool using both 7

9 prosthetic and bone images. Accordingly, we do not sustain Rejection III because the Examiner has not set forth how the teachings in Lang and Dore render obvious generating a surgical guide image from the bone surface image and an image of a prosthetic implant. Rejection IV Obviousness in view of Carson Claim 15 requires, in relevant part, a registration module that determines changes in the surface of the bone using received positional data from a reference pointer. The Examiner found that Carson teaches a mouse (reference pointer) and determines changes in the surface of the bone by determining bone spike holes using coordinate data. Ans. 5-6 (citing to Carson, paras. [0094] and [0126]). As Appellant points out, however, even assuming the mouse in Carson were a reference pointer in the manner required by claim 15, the bone spike data in Carson is not received from the mouse. Br. 28. Carson states that a probe 26 can be used to designate features of a bone, such as bone spike holes, to establish known coordinates. Carson, para. [0126]. As the probe 26 is placed onto such a known feature, the system saves the coordinates of the probe. Id. Thus, the bone spike location is not received from a mouse, but rather probe 26. Consequently, the Examiner has not made a finding showing that Carson teaches or suggests a registration module that determines changes in the surface of the bone using received positional data from a reference pointer in the manner required by claim 15, and we do not sustain Rejection IV. 8

10 DECISION We affirm the Examiner s decision regarding the 35 U.S.C. 112, first paragraph, rejection of claims 15 and as failing to comply with the written description requirement (Rejection I). We reverse the Examiner s decision regarding the 112, first paragraph, rejection of claim 18 as failing to comply with the enablement requirement (Rejection II). We reverse the Examiner s decision regarding the 103(a) rejections of claims 1-15 and (Rejections III, IV). No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R (a)(1)(iv). AFFIRMED-IN-PART hh 9