Carl Deirmengian et al.Download PDFPatent Trials and Appeals BoardAug 19, 201914750716 - (D) (P.T.A.B. Aug. 19, 2019) Copy Citation APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/750,716 06/25/2015 Carl DEIRMENGIAN 76960 7590 08/19/2019 Fay Kaplun & Marcin, LLP 150 Broadway, suite 702 New York, NY 10038 UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONERFORPATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov ATTORNEY DOCKET NO. 10139/20012 CONFIRMATION NO. 6991 EXAMINER HENSON, DEVIN B ART UNIT PAPER NUMBER 3791 MAIL DATE DELNERYMODE 08/19/2019 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) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CARL DEIRMENGIAN et al. Appeal 2018-006180 Application 14/750,716 Technology Center 3700 ERRATUM The Decision on Appeal for the above-identified application mailed August 19, 2019 contains an error. The disposition on the last page, "AFFIRMED," is removed and replaced with "REVERSED." All other portions the Decision on Appeal remain unchanged. Any confusion caused regarding this matter is regretted. If there any questions pertaining to this Erratum, please contact the Patent Trial and Appeal Board at 571-272-9797. BAR UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CARL DEIRMENGIAN, GEORGE MIKHAIL, and GLEN PIERSON 1 Appeal2018-006180 Application 14/750,716 Technology Center 3700 Before JENNIFER D. BAHR, JOHN C. KERINS, and FREDERICK C. LANEY, Administrative Patent Judges. KERINS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's rejection of claims 21--40. We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE. 1 DePuy Synthes Products, Inc. (Appellant) the applicant as provided in 37 C.F .R. § 1.46 and is identified as the real party in interest. Appeal Br. 2. Appeal 2018-006180 Application 14/7 50,716 THE CLAIMED SUBJECT MATTER Appellant's invention relates to a system and method for treating a bone. Claims 21, 30, and 36, reproduced below, are illustrative: 21. A system for treating a bone, comprising: an implant sized and shaped to be attached to a bone and including a first sensor and a second sensor, the first sensor positioned on a first portion of the implant which extends over a weakened portion of bone in an operative position, the first sensor being configured to measure a first strain on the first portion, the second sensor being positioned on a second portion of the implant which extends over an unweakened portion of bone in the operative position, the second sensor being configured to measure a second strain on the second portion; and a processing device calculating a ratio of the first strain to the second strain to normalize an effect of loads on the bone and track the healing of the bone. 30. A system for treating a bone, comprising: an implant configured for attachment to a bone, the implant including a first sensor on a first portion of the implant which, in an operative position, is configured to extend over a weakened portion of bone to measure a first strain on the first portion; a second sensor positioned over an unweakened portion of bone to measure a second strain on the second portion; and a processing device calculating a ratio of the first strain to the second strain to normalize an effect of loads on the bone. 36. A method for treating a bone, comprising: positioning an implant in an operative position over a selected portion of a bone so that a first portion of the implant extends over a weakened portion of the bone and a second portion of the implant extends over an unweakened portion of the bone; 2 Appeal 2018-006180 Application 14/7 50,716 measuring a first strain via a first sensor on the first portion of the implant; positioning a second sensor over the unweakened portion of the bone; measuring a second strain via the second sensor; and calculating a ratio of the first strain to the second strain to normalize an effect of loads on the bone and track healing of the bone. THE REJECTIONS The Examiner rejects: (i) claims 21--40 under 35 U.S.C. § 101; (ii) claims 21, 23, and 26--40 under 35 U.S.C. § I03(a) as unpatentable over Morgan '782 (US 2006/0052782 Al, published Mar. 9, 2006); and (iii) claims 22, 24, and 25 stand under 35 U.S.C. § I03(a) as unpatentable over Morgan '782 and Morgan '597 (US 2008/0300597 Al, published Dec. 4, 2008). ANALYSIS Claims 21-40--35 US.C. § 101 Introduction The Examiner takes the position that the claims are "directed to an abstract idea." Final Act. 2. The Examiner specifically determines, with reference to independent claim 21, that the limitation of "calculating a ratio of the first strain to the second strain to normalize an effect of loads on the bone and track healing of the bone" is an abstract idea. Id. at 2-3. In particular, the Examiner determines that "the first and second strains/loads on weakened and unweakened portions of a bone represent natural 3 Appeal 2018-006180 Application 14/7 50,716 physiological phenomena, and the calculated ratio is a basic mathematical principle that is simply implemented on a physical machine (i.e., the processing device)." Ans. 15. The Examiner acknowledges that claim 21 contains "additional elements," but finds that those elements are insufficient to make the claim as a whole significantly more than the recited abstract idea, because the additional limitations are "well-understood, routine, and conventional in the art." Final Act. 3; see also Adv. Act. 2 (identifying "'an implant[,]' 'a first sensor[,]' 'a second sensor' and 'a processing device' as additional elements in independent claim 21," and finding that "[t]he implant and sensors are well-understood in the art and simply represent components which would routinely be used in applying the abstract idea"); and Ans. 14 (finding that "implants having sensors are well-established in the field of orthopedics"). The Examiner makes similar determinations with respect to independent claims 30 and 36. See Final Act. 8-10; see also Adv. Act. 2; Ans. 14--19. Appellant argues that inclusion of data analysis within the claims does not mean the claims are directed to an abstract idea. Appeal Br. 4; see also id. at 4--10; see also Reply Br. 2---6. Appellant submits that, to the contrary, "[t]aken as a whole, the additional elements ... are clearly directed to a structurally defined implant," and that the recited physical elements and steps clearly would be patent eligible subject matter in the absence of the claim language regarding the ratio of strain readings. Appeal Br. 7; see also id. at 4--1 O; see also Reply Br. 2---6. Appellant maintains that the Examiner "has failed to explain reasons why 'the additional elements taken 4 Appeal 2018-006180 Application 14/7 50,716 individually, and also taken as a combination, do not result in the claim as a whole amounting to more than the judicial exception." Appeal Br. 7. Principles of Law An invention is patent-eligible if it claims a "new and useful process, machine, manufacture, or composition of matter." 35 U.S.C. § 101. However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit exceptions: "[l]aws of nature, natural phenomena, and abstract ideas" are not patentable. E.g., Alice Corp. v. CLS Bank Int 'l, 573 U.S. 208, 216 (2014). In determining whether a claim falls within an excluded category, we are guided by the Supreme Court's two-step framework, described in Mayo and Alice. Id. at 217-18 ( citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework, we first determine what concept the claim is "directed to." See Alice, 573 U.S. at 219 ("On their face, the claims before us are drawn to the concept of intermediated settlement, i.e., the use of a third party to mitigate settlement risk."); see also Bilski v. Kappas, 561 U.S. 593, 611 (2010) ("Claims 1 and 4 in petitioners' application explain the basic concept of hedging, or protecting against risk."). Concepts determined to be abstract ideas, and thus patent ineligible, include certain methods of organizing human activity, such as fundamental economic practices (Alice, 573 U.S. at 219-20; Bilski, 561 U.S. at 611 ); mathematical formulas (Parker v. Flook, 437 U.S. 584, 594--95 (1978)); and mental processes (Gottschalkv. Benson, 409 U.S. 63, 69 (1972)). Concepts determined to be patent eligible include physical and chemical processes, such as "molding rubber products" (Diamond v. Diehr, 450 U.S. 175, 191 5 Appeal 2018-006180 Application 14/7 50,716 (1981 )); "tanning, dyeing, making water-proof cloth, vulcanizing India rubber, smelting ores" (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S. 252, 267---68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))). In Diehr, the claim at issue recited a mathematical formula, but the Supreme Court held that "[a] claim drawn to subject matter otherwise statutory does not become nonstatutory simply because it uses a mathematical formula." Diehr, 450 U.S. at 187, 191 ("We view respondents' claims as nothing more than a process for molding rubber products and not as an attempt to patent a mathematical formula."). Having said that, the Supreme Court also indicated that a claim "seeking patent protection for that formula in the abstract ... is not accorded the protection of our patent laws,[] and this principle cannot be circumvented by attempting to limit the use of the formula to a particular technological environment." Id. ( citing Benson and Flook), 187 ("It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection."). If the claim is "directed to" an abstract idea, we tum to the second step of the Alice and Mayo framework, where "we must examine the elements of the claim to determine whether it contains an 'inventive concept' sufficient to 'transform' the claimed abstract idea into a patent- eligible application." Alice, 573 U.S. at 221 ( quotation marks omitted). "A claim that recites an abstract idea must include 'additional features' to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea]."' Id. (quoting Mayo, 566 U.S. at 77). 6 Appeal 2018-006180 Application 14/7 50,716 "[M]erely requir[ing] generic computer implementation[] fail[ s] to transform that abstract idea into a patent-eligible invention." Id. The PTO recently published revised guidance on the application of § 101. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (hereinafter "Guidance"). Under the Guidance, we first look to whether the claim recites: (1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a}-(c), (e}-(h)). Only if a claim: ( 1) recites a judicial exception; and (2) does not integrate that exception into a practical application, do we then look to whether the claim: (3) adds a specific limitation beyond the judicial exception that is not "well-understood, routine, conventional" in the field (see MPEP § 2106.05(d)); or (4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. See Guidance. Analysis Independent claims 21 and 3 0 recite a system, and independent claim 36 recites a process, which places the claims in statutory categories of patent-eligible subject matter, subject to a potential judicial exception to eligibility. 7 Appeal 2018-006180 Application 14/7 50,716 The dispute is over whether claims 21, 30, and 36 are directed to an abstract idea, and, if so, whether the claim recites additional elements that amount to significantly more than the judicial exception. With the recently- issued Guidance, the first inquiries in these determinations are evaluating whether the claim recites a judicial exception, and if it does, whether additional elements are present that integrate the judicial exception into a practical application. As noted above, in the present appeal, the Examiner characterizes the claims as being directed to a judicial exception in the form of an abstract idea, in regarding the claimed step of determining a ratio of first and second strains measured by first and second sensors, respectively, or a processor for doing so, as a "basic mathematical principle" or "a mental process that can be performed in the human mind or by a human using conventional equipment." Ans. 15. Appellant does not dispute that the recited step of determining the claimed ratio could be performed by a human as a mental step. Accordingly, there is agreement as to claim construction at least insofar as the claims recite an abstract idea in the form of a mental step. We thus tum our attention to whether additional elements are present in the claims that integrate the judicial exception into a practical application. For the reasons discussed below, we find that such additional elements are present in the claim. System claims 21 and 30, as well as method claim 36, implicate and require the presence of certain structure and particular positioning of the sensors and the bone implant in order to perform the claimed strain- measuring steps. As for structure, the claims require an implant that is attached over a selected portion of a bone, and first and second strain- 8 Appeal 2018-006180 Application 14/7 50,716 measuring sensors. App. Br. 17-30, Claims Appendix. The first sensor is required to measure strain on a first portion of the implant, with the sensor being mechanically coupled to a weakened area of the bone. Id. The Examiner advances several assertions in support of the position that the claims do not recite additional elements that amount to significantly more than the judicial exception. The Examiner views the recited implants and sensors as being claimed at a "high level of generality" and are thus convention and well-understood, and "do not narrowly limit the claim to a particular technological process or apparatus." Final Act. 14. The particular arrangement of the sensors on the implant and the positioning of the implant on the bone are, according to the Examiner, "merely contextual, intended- use type limitations that do not structurally limit the claimed invention in such a way as to amount to significantly more than the abstract idea." Id. at 15. The Examiner opines that "the details regarding attachment/positioning relative to the bone only generally link the use of the judicial exception to the technological environment." Id.; see also Ans. 14. The Examiner additionally characterizes the recited arrangement of the sensors on the implant and the positioning of the implant on the bone as being "well within the understanding of one skilled in the art, so the combination of these elements does not result in a non-conventional and non-generic arrangement." Ans. 15-16. The Examiner does not cite to evidence in support of the contentions as to what allegedly would be understood by the person of ordinary skill in the art. Furthermore, the recently issued Guidance does not have us reach this inquiry until after a determination is made as to whether the claim integrates the judicial exception, in this case, an abstract idea in the form of 9 Appeal 2018-006180 Application 14/7 50,716 a mental step, into a practical application. Here, it is apparent that the particular placement of the implant and the positioning of the sensors to be coupled to a weakened portion (first sensor) and to a non-weakened portion of the bone spaced from the fracture (second sensor), allows for a determination of a ratio of strains measured at the two sensors, in order to normalize the effect of loads on the bone. 2 This results in a practical application, that of obtaining information as to the load-bearing capability of a weakened (fractured and healing) portion of a bone, relative to the load- bearing capability of a non-weakened (intact) area of bone. Although not couched in terms of integrating a judicial exception into a practical application, the court in Thales Visionix Inc. v. United States reached the same conclusion in assessing the patent eligibility of a claim fairly similar to claim 21 here on appeal. 3 Claim 22 in that decision involved a method claim for determining an orientation of an object relative to a moving reference frame based on signals received from two inertial sensors mounted in particular locations, one on the object, and the other on the moving reference frame. Thales Visionix Inc., 850 F.3d at 1345--46. The orientation-determining step involved the use of at least one mathematical equation, but the court held, "[ t ]hat a mathematical equation is required to complete the claimed method and system does not doom the claims to abstraction." Id. at 1349. 2 This normalization is described in the Specification as providing data as to the stiffness of the bone at the fracture site, which is discussed as being useful in assessing the healing of the fracture. Spec. 9. 3 Thales Visionix Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017). 10 Appeal 2018-006180 Application 14/7 50,716 The court in Thales Visionix ultimately found that "[t]he claims specify a particular configuration of inertial sensors and a particular method of using the raw data from the sensors in order to more accurately calculate the position and orientation of an object on a moving platform." Id. Appealed claim 21 before us, too, uses a particular configuration of sensors relative to an implant and fractured bone, and using data from the sensors in order to generate a ratio of strains measured in a fractured bone region and in a non-weakened region, to provide a normalized value or effect of loads on the bone at those locations. To the extent that the claim 15 method might be viewed as less mathematically complex than that in Thales Visionix, we regard this as not being germane to the patent eligibility determination. We appreciate the Examiner's concern that the claims do not "positively recite doing anything with the determined ratio - there is no tangible result/transformation/output of a particular result or improvement." Ans. 14--15. Although the Examiner is correct that such considerations have been taken into account in prior court decisions involving the patent eligibility of certain methods, with the claims as currently presented, the absence of some further step or limitation does not undermine the eligibility of the claim because, even without such a step, the claims integrate the judicial exception (mental process as abstract idea) into a practical application, i.e., the use of a particular configuration of sensors relative to an implant and fractured bone, and using the data from the sensors in order to generate a ratio of strains measured in a weakened bone region and in a non- weakened region, to provide a normalized value or effect of loads on the bone at those locations. 11 Appeal 2018-006180 Application 14/7 50,716 The rejection of independent claims 21, 30, and 36, and of claims 22- 29, 31-35, and 37--40 depending therefrom, under 35 U.S.C. § 101, is not sustained. Claims 21, 23, and 26-40--Unpatentability over Morgan '782 The Examiner finds that Morgan '782 discloses a device and method as set forth in independent claims 21, 30, and 36, with the exception that Morgan '782 "does not explicitly teach calculating a ratio of the first strain to the second strain to normalize an effect of loads on the bone." Final Act. 6, 8, and 11. The Examiner finds relevant to the obviousness inquiry that Morgan '782 discloses comparing strain measurements over time from multiple sensors at each of the sensor locations, to identify satisfactory or unsatisfactory loading conditions as well as to determine how much load is carried by the bone relative to the implant. Id. at 6. The Examiner continues, averring that the claimed ratio calculation "could easily be performed by a general purpose processing device/computer in conjunction with conventional strain gauges," and concluded that it would have been obvious to modify the processing device of Morgan '782 to calculate such a ratio. Id. The asserted motivation for doing so would have been "to ensure that the implant is sufficiently engaged with the bone at both the weakened and unweakened portions and to track the transfer of loading at each portion to determine whether the bone is healing at an appropriate rate." Id. The flaw in the Examiner's above reasoning is that Morgan '782 already does ensure that the implant is sufficiently engaged with the bone wherever the sensors are placed, and tracks the transfer of loading at each 12 Appeal 2018-006180 Application 14/7 50,716 sensor position, on a sensor-by-sensor basis. As pointed out by Appellant, "the Examiner is simply restating the utility of the Morgan ['782] sensors," and that, to the extent that the Morgan '782 sensors do monitor strain at various locations on the implant to assess fracture healing rate, "[ they do] so in a completely different, and more simplified, way than the present application," thus providing no motivation to modify the system to align with the presently-claimed system. Appeal Br. 13. The Examiner, in the Answer, provides cites to various paragraphs in the Morgan '782 reference, noting that these support the position that "there was a recognized need in the art to use various strain sensors positioned on bone implants to track healing and monitor bone strength/fracture. Ans. 20. The use of a plurality of sensors and the obtention and display of strain measurements from each of the sensors, according to the Examiner, Id. provides a quantitative and qualitative comparison of the different strains experienced in various portions of the implant, and one skilled in the art would readily and intuitively understand that calculating a ratio between these strains measured by the different sensors would only augment the teachings of Morgan '782. However, we agree with Appellant that "nothing in the prior art shows or suggests ... the usefulness of such a ratio of strain readings at two different portions of the bone - much less a ratio of a strain reading from a weakened portion of the bone to a non-weakened portion of the bone as claimed." Reply Br. 8. In other words, as Appellant contends, the utility of obtaining a ratio of the first and second strain readings is not disclosed or suggested by the prior art. 13 Appeal 2018-006180 Application 14/7 50,716 Accordingly, we do not sustain the rejection of claims 21, 23, and 26- 40 as being unpatentable over Morgan '782. Claims 22, 24, and 25--Unpatentability Over Morgan '782 and Morgan '597 The Examiner does not rely on Morgan '597 in any manner that remedies the basic deficiency in the teachings of Morgan '782, discussed above. The rejection of claims 22, 24, and 25 over Morgan '782 and Morgan '597 is not sustained. DECISION The Examiner's rejection of claims 21--40 under 35 U.S.C. § 101 is reversed. The Examiner's rejections of claims 21--40 under 35 U.S.C. § 103(a) are reversed. AFFIRMED 14 Copy with citationCopy as parenthetical citation