TEXAS SCOTTISH RITE HOSPITAL FOR CHILDREN

Patent Trials and Appeals Board

Mar 15, 2022

2021002656 (P.T.A.B. Mar. 15, 2022)

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 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/716,304 09/26/2017 John D. Ross 10048266-50391344 3134 165169 7590 03/15/2022 Texas Scottish Rite Hospital for Children (48017) 14951 North Dallas Parkway Suite 400 Dallas, TX 75254 EXAMINER LEE, SHUN K ART UNIT PAPER NUMBER 2884 NOTIFICATION DATE DELIVERY MODE 03/15/2022 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): eflores@chalkerflores.com ipdocketing@haynesboone.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JOHN D. ROSS, MIKHAIL L. SAMCHUKOV, and ALEXANDER M. CHERKASHIN ____________ Appeal 2021-002656 Application 15/716,304 Technology Center 2800 ____________ Before KAREN M. HASTINGS, DEBRA L. DENNETT, and MERRELL C. CASHION, JR., Administrative Patent Judges. CASHION, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to finally reject claims 1-31 and 33. We have jurisdiction under 35 U.S.C. § 6(a). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies TEXAS SCOTTISH RITE HOSPITAL FOR CHILDREN and ORTHOFIX Srl as the real parties in interest. Appeal Br. 3. Appeal 2021-002656 Application 15/716,304 2 The invention “relates in general to the field of radiography aids, and more particularly, to a radiography aid for an external fixator used for producing orthogonal radiographs.” Spec. ¶ 2. Claim 1, reproduced from the Claims Appendix to the Appeal Brief, illustrates the invention: 1. A method of determining a position of one or more objects affixed to an external fixation device in three dimensions comprising: attaching a radiographic reference device to the external fixation device, wherein the radiographic reference device comprises at least two surfaces separated by a first angle, wherein the at least two surfaces of the radiographic reference device are positioned at a second angle relative to a longitudinal axis of the external fixation device; positioning a first surface of the radiographic reference device on a surface to capture a first radiographic image of the external fixation device and the one or more objects; repositioning the external fixation device to position a second surface of the radiographic reference device on the surface to capture a second radiographic image of the external fixation device and the one or more objects that differs in position from the first radiographic image by the first angle; and calculating the position of the one or more objects in three dimensions based on distances measured from the first and second radiographic images with the first and second angles. Independent claim 31 recites a method of taking substantially orthogonal radiographs that is broader in scope than the method of claim 1. Independent claims 16 and 33 recite systems that are apparatuses to practice the methods of claims 1 and 31. Appeal 2021-002656 Application 15/716,304 3 Appellant requests review of the following rejections from the Examiner’s Final Action (see generally id.): I. claims 1-3, 5, 7-9, 11, 16-18, 20, 22-24, and 26 rejected under 35 U.S.C. § 103 as unpatentable over Fleig (US 2009/0003531 A1, published January 1, 2009) and Agee (US 2004/0249375 A1, published December 9, 2004); II. claims 4, 15, 19, and 30 rejected under 35 U.S.C. § 103 as unpatentable over Fleig, Agee, and Krause (US 6,701,174 B1, issued March 2, 2004); III. claims 6 and 21 rejected under 35 U.S.C. § 103 as unpatentable over Fleig, Agee, and Engels (US 3,581,088, issued May 25, 1971); IV. claims 10 and 25 rejected under 35 U.S.C. § 103 as unpatentable over Fleig, Agee, and Froning (US 4,543,091, issued September 24, 1985); V. claims 12-14 and 27-29 rejected under 35 U.S.C. § 103 as unpatentable over Fleig, Agee, and Buckland (US 5,485,856, issued January 23, 1996); VI. claim 31 rejected under 35 U.S.C. § 103 as unpatentable over Fleig, Agee, and Buckland; and VII. claim 33 rejected under 35 U.S.C. § 103 as unpatentable over Fleig, Schwieger (US 2010/0125273 A1, published May 20, 2010), and Agee. For the most part, Appellant argues independent claims 1, 16, 31, and 33 together and relies on these arguments to address the rejections of the remaining claims. See generally Appeal Br. Appellant also presents separate additional arguments for dependent claim 8 and independent claim 33. See generally id. Accordingly, we select claim 1 as representative of the subject matter claimed. Claims 2-7 and 9-31 stand or fall with claim 1. We Appeal 2021-002656 Application 15/716,304 4 address the additional arguments for claims 8 and 33 separately. OPINION After review of the respective positions by Appellant and the Examiner, we affirm the Examiner’s rejections of claims 1-31 and 33 under 35 U.S.C. § 103 for essentially the reasons the Examiner presents. We add the following for emphasis. Claims 1 (Rejection I) Claim 1 recites a method of determining a position of one or more objects affixed to an external fixation device in three dimensions by using a radiographic reference device attached to the external fixation device and positioning the attached radiographic reference device in two different orientations (angles) to capture a first and second radiographic images of the external fixation device and the one or more objects. Claim 1 recites the radiographic reference device comprises at least two surfaces separated by a first angle, wherein the at least two surfaces of the radiographic reference device are positioned at a second angle relative to a longitudinal axis of the external fixation device. Claim 1 further recites using the images to calculate the position of the one or more objects in three dimensions based on distances measured from the first and second radiographic images. The Examiner finds Fleig discloses a method of determining a position of a plurality of objects in three dimensions using a radiographic reference device 1 comprising at least two surfaces 7-9 separated by a first angle, wherein the at least two surfaces of the radiographic reference device are positioned at different angles relative to a longitudinal axis of the object to be radiograph. Final Act. 4-5; Fleig ¶ 24. The Examiner further finds Appeal 2021-002656 Application 15/716,304 5 Fleig teaches or suggests calculating the position of the plurality of objects in three dimensions based on distances measured from the first and second radiographic images. Final Act. 5; Fleig ¶ 3. The Examiner finds Fleig fails to disclose affixing the object to be radiographed to an external fixator. The Examiner turns to Agee for the missing feature. Final Act. 5. The Examiner finds Agee teaches it is well known to use external fixators attached to a support to stabilize some objects, such as fractured bones, on an x-ray table to hold the object in a fixed position while x-ray images are taken. Final Act. 5-6; Agee Figure 12; ¶ 65. The Examiner determines it would have been obvious to one skilled in the art to modify Fleig’s method by attaching Fleig’s radiographic reference device to an external fixator to allow the surgeon to manipulate the bones and make necessary adjustments based on the calculations from the distances measured from the first and second radiographic images. Final Act. 6-7. Appellant argues Fleig’s upright positioning device is unsuitable for positioning of Agee’s forearm external fixator. Appeal Br. 12. According to Appellant, the Fleig’s upright positioning device is for positioning a patient's feet while Agee discloses Agee discloses an external fixator for Colles’ fracture. Id. at 11. Appellant contends that Agee does not teach or suggest that the disclosed external fixator could be used for any other application than treatment of a Colles’ fracture of the radius. Id. Appellant also contends Fleig’s upright positioning device may be practical for positioning a patient’s legs, hips, etc. but would be ineffective in positioning a patient’s forearm. Id. at 12. Thus, Appellant asserts the Examiner fails to provide any articulated explanation supporting why or how one of ordinary skill in the art would or could combine Fleig’s foot placement upright positioning Appeal 2021-002656 Application 15/716,304 6 device with Agee’s external fixator for forearm fractures to arrive at the claimed invention. Id. at 11-12. Appellant additionally argues Fleig’s upright positioning device is placed on the floor and the patient then stands on the device for planning a treatment and, thus, Fleig fails to teach or suggest attaching implants to the upright positioning device. Appeal Br. 13; Fleig ¶¶ 3, 23, 24. Appellant further contends the implants are not attached to Fleig’s upright positioning device at the time of the device’s use because the images are captured for planning a treatment such as to roughly plan the placement of implants. Appeal Br. 13; Fleig ¶ 3. Appellant’s arguments do not identify reversible error in the Examiner’s determination of obviousness. The premise of Appellant’s arguments is based on bodily incorporation. It is well established that the obviousness inquiry does not ask “whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole.” In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc); see also In re Keller, 642 F.2d 413, 425 (CCPA 1981) (stating “[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference”). As the Examiner explains, Agee teaches it is well known to use external fixators attached to a support to stabilize some objects, such as fractured bones, on an x-ray table to hold the object in a fixed position while x-ray images are taken. Final Act. 5-6; Agee Figure 12; ¶ 65. Thus, Agee teaches an alternate means for placing objects in an x-ray machine for imaging purposes. Given that both Fleig and Agee are both directed to x-ray imaging of an object, there is a reasonable basis for one skilled in the art to Appeal 2021-002656 Application 15/716,304 7 have modified Fleig’s method of imaging by incorporating an external fixator, as Agee teaches, and to have reasonably expected that Fleig’s modified method would be suitable for Fleig’s stated purposes. In re O’Farrell, 853 F.2d 894, 904 (Fed. Cir. 1988) (“For obviousness under § 103, all that is required is a reasonable expectation of success.”); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (explaining that patentable subject matter must “involve more than the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for the improvement”). While Appellant argues that Fleig and Agee focus on different objects (parts of the body), Appellant fails to explain adequately why one skilled in the art, using no more than ordinary creativity, would not have been capable of using the appropriate fixator for the appropriate object. See KSR, 550 U.S. at 421 (2007) (“A person of ordinary skill is also a person of ordinary creativity, not an automaton.”); see also In re Sovish, 769 F.2d 738, 743 (Fed. Cir. 1985) (presuming skill on the part of one of ordinary skill in the art). Appellant argues that, contrary to the Examiner’s reasoning, images collected from multiple angles for later evaluation and for roughly planning a treatment is not a teaching or suggestion of the claimed calculating step. Appeal Br. 14. Appellant further contends the Examiner’s interpretation of Fleig’s disclosure regarding the storage of implant data in a computer system as including the claimed calculating step is unreasonable because Fleig lacks any such teaching or suggestion. Id. Appellant also asserts the images resulting from use of Fleig’s upright positioning device are sufficient for roughly planning a treatment and it would be unreasonable to conclude that Appeal 2021-002656 Application 15/716,304 8 they would be sufficient for calculating the position of the one or more objects in three dimensions as claimed. Id. at 15. Appellant’s arguments are unpersuasive of reversible error for the reasons the Examiner presents. Ans. 3-5, 7-8. Moreover, the Specification incorporates by reference the disclosure of US 2016/0042571 A1 to Mikheev.2 Spec. ¶ 5. The Specification describes Mikheev as a “known [technique] for using orthogonal radiographs to recreate a three-dimensional model[] of a patient’s body.” Id. Mikheev describes “3-D modeling of a body part by using mathematical models involving the known geometry of an object, such as an external fixator, and its projections on 2-D roentgenograms to derive the positions of the X-ray Source, the body parts, and the objects in space.” Mikheev ¶ 37. Mikheev further describes “[c]ertain embodiments employ mathematical models that use a plurality of markers to produce the 3-D modeling of objects.” Id. ¶ 38. Thus, through the incorporation by reference of Mikheev, the Specification acknowledges that the claimed calculating step is known in the art. An applicant cannot defeat an obviousness rejection by asserting that the cited references fail to teach or suggest elements which the applicant has acknowledged are taught by the prior art. Constant v. Advanced Micro- Devices, Inc., 848 F. 2d 1560, 1570 (Fed. Cir. 1988) (“A statement in a patent that something is in the prior art is binding on the applicant and 2 We note that the inventive entities of the instant Application and Mikheev include common inventors (Mikhail Samchukov and Alexander Cherkashin) and a common assignee (TEXAS SCOTTISH RITE HOSPITAL FOR CHILDREN). Thus, Mikheev is Appellant’s own prior art. Appeal 2021-002656 Application 15/716,304 9 patentee for determinations of anticipation and obviousness.”) and In re Nomiya, 509 F.2d 566, 571n.5 (CCPA 1975) (A statement by an applicant that certain matter is prior art is an admission that the matter is prior art for all purposes). Appellant argues one of ordinary skill in the art would not substitute an external fixator for the Fleig’s implants because Fleig appears to be suggesting an implant for positioning within the body. Appeal Br. 16; Fleig ¶ 3. According to Appellant, Fleig’s upright positioning device takes images before the implant is installed. Appeal Br. 16. Thus, Appellant argues that combining the teachings of the cited art would render Fleig unsatisfactory for its intended purpose of planning the placement of an implant. Appeal Br. 16. Appellant also argues modifying Fleig for attaching Agee’s external fixator would require a substantial reconstruction and redesign of the elements shown in Fleig and would change the basic principle under which the Fleig construction was designed to operate (e.g., rest on the floor and orient a patient's feet). Appeal Br. 17. We have considered Appellant’s arguments in full but are unpersuaded of reversible error in the Examiner’s conclusion of obviousness. The focus on Fleig’s potential use of implants at some time in the treatment process is misplaced because the issue is whether one skilled in the art would provide a means to stabilize an object for effective x-ray imaging. See Spec. ¶ 26. Agee teaches this concept. Final Act. 5-6; Agee Figure 12; ¶ 65. Given that Fleig is also directed to effective x-ray imaging of an object (Fleig ¶ 9), Appellant fails to explain how the use of an external Appeal 2021-002656 Application 15/716,304 10 fixator necessarily renders Fleig’s device and method unsatisfactory for its intended purpose. In addition, Appellant fails to explain adequately how the use of an external fixator, when needed, would change the basic principle of Fleig’s device and method to provide effective x-ray imaging given that Agee teaches such use in an x-ray device. Agee ¶ 65. Thus, Appellant fails to explain adequately why one skilled in the art, using no more than ordinary creativity, would not have been capable of providing a means to stabilize an object, such as Agee’s fixator, when necessary for effective x-ray imaging. See KSR, 550 U.S. at 421; see also Sovish, 769 F.2d at 743. Claim 8 (Rejection I) Claim 8 recites a method using a radiographic reference device that further comprises a slot adapted to receive one or more struts. The Examiner finds that Agee teaches the concept of using a post 123 in combination with table 122 to attach an external fixator 25, 26, 31, 124 to the table. Final Act. 5-6; Agee Figure 12, ¶ 65. Post 123 works in tandem with sliding joint 125 to place the external fixator as deemed appropriate by the user. Agee Figure 12, ¶ 65. The Examiner finds it would have been obvious to one having ordinary skill in the art to use adjustable-length struts in place of Agee’s adjustable assembly 123, 125 to attach Fleig’s radiographic reference device to an external fixation device with adjustable- length struts received in a slot of the radiographic reference device to allow better stabilization of the object being radiographed. Final Act. 6-7. Appellant argues Appellant attaching Fleig’s upright positioning device to Agee’s external fixator with adjustable-length struts received in a slot as proposed by the Examiner is not a legitimate reason for combining Appeal 2021-002656 Application 15/716,304 11 references because Agee already provides for these functions by the external fixator of Agee itself and one skilled in the art would not turn to Fleig for such a redundant purpose. Appeal Br. 12; Agee ¶ 66; see also Ans. 4-5. Appellant’s arguments are unpersuasive of reversible error because they do not address the rejection the Examiner presents. Appellant’s arguments do not explain adequately why one skilled in the art would not be capable of using a strut assembly to connect an external fixator with Fleig’s radiographic reference device. In fact, the Specification acknowledges through the incorporation by reference of Mikheev that struts are commonly used in connection with external fixators. Mikheev Figure 1B, ¶¶ 3, 36. Thus, Appellant fails to explain why one skilled in the art, using no more than ordinary creativity, would not have been capable of using an adjustable-length strut for the adjustable means of Agee to attach the external fixator to Fleig’s radiographic reference device. See KSR, 550 U.S. at 421; see also Sovish, 769 F.2d at 743. Claim 33 (Rejection VII) Claim 33 recites a system (apparatus) for determining a position of one or more objects affixed to an external fixation device in three dimensions comprising an external fixator having a ring used for attachment to a radiographic reference device. We refer to the Examiner’s Final Office Action for the complete statement of rejection of claim 33. Final Act. 21-24. The Examiner relies on Schwieger as teaching an external fixator structure comprising a ring as a well-known type of fixator for bone healing. Final Act. 23; Schwieger ¶¶ 5, 59. Appeal 2021-002656 Application 15/716,304 12 To the extent that Appellant relies on the arguments presented for claim 1 to address the rejection of claim 33, we again find these arguments unpersuasive of reversible error in the Examiner’s determination of obviousness for the reasons the Examiner presents and we give above. Appellant additionally argues one skilled in the art would not combine the teachings of Schweiger with the combined teachings of Fleig and Agee because Schwieger teaches a rigid external skeletal fixator while Agee teaches an external fixator that requires movable components to adjust. Appeal Br. 18; Schwieger ¶ 59; Agee ¶¶ 20, 38. Appellant contends Schwieger’s ring design of the rigid external skeletal fixator would not provide the adjustability facilitated by the rails, pinblocks, etc. of Agee. Appeal Br. 19. Thus, Appellant argues the Examiner’s purported motivation to combine Schwieger with Fleig and Agee is improper at least because the external skeletal fixator of Schwieger is rigid with fixed distances whereas the external fixator of Agee requires movable components to adjust. Appellant arguments’ lack persuasive merits for the reasons the Examiner presents. Ans. 11-13. The Examiner relies on Schwieger as teaching an alternate external fixator that could be used in connection with an x-ray imaging device. Moreover, claim 33 does not describe that the external fixator comprising the ring must be flexible. Thus, Appellant’s arguments are not commensurate in scope with the claims. Further, the Specification recognizes through the incorporation by reference of Mikheev, that the claimed external fixator is well known in the art for use with x-ray imaging devices. Spec. ¶ 5; Mikheev Figure 1B. See Constant, 848 F. 2d at 1570; see also Nomiya, 509 F.2d at 571, n.5. Appeal 2021-002656 Application 15/716,304 13 Accordingly, we affirm the Examiner’s prior art rejections of claims 1-31 and 33 under 35 U.S.C. § 103 for the reasons the Examiner presents and we give above. Arguments not specifically addressed are deemed not persuasive for the reasons the Examiner presents. CONCLUSION The Examiner’s prior art rejection of claims 1-31 and 33 are affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-3, 5, 7-9, 11, 16-18, 20, 22-24, 26 103 Fleig, Agee 1-3, 5, 7-9, 11, 16-18, 20, 22-24, 26 4, 15, 19, 30 103 Fleig, Agee, Krause 4, 15, 19, 30 6, 21 103 Fleig, Agee, Engels 6, 21 10, 25 103 Fleig, Agee, Froning 10, 25 12-14, 27-29 103 Fleig, Agee, Buckland 12-14, 27-29 31 103 Fleig, Agee, Buckland 31 33 103 Fleig, Schwieger, Agee 33 Overall Outcome 1-31, 33 Appeal 2021-002656 Application 15/716,304 14 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED