Mylan Inc.Download PDFPatent Trials and Appeals BoardMay 28, 20202019001929 (P.T.A.B. May. 28, 2020) Copy Citation 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. 13/907,028 05/31/2013 Kevin Ostrander 097693-1002533 9296 122945 7590 05/28/2020 Mylan Pharmaceuticals Inc. 5005 Greenbag Road Morgantown, WV 26501 EXAMINER COBANOGLU, DILEK B ART UNIT PAPER NUMBER 3626 NOTIFICATION DATE DELIVERY MODE 05/28/2020 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): mylan_docketing@cardinal-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte KEVIN OSTRANDER and JOHN W. DENNY Appeal 2019-001929 Application 13/907,028 Technology Center 3600 ____________ Before BRUCE T. WIEDER, TARA L. HUTCHINGS, and ROBERT J. SILVERMAN, Administrative Patent Judges. SILVERMAN, 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 rejecting claims 1–10 and 19–27. We have jurisdiction under 35 U.S.C. § 6(b). An oral hearing was held on May 11, 2020. We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Mylan Incorporated. Appeal Br. 1. Appeal 2019-001929 Application 13/907,028 2 ILLUSTRATIVE CLAIM 1. A method of using an emergency medicament device, the method comprising: determining a physical location of a mobile device using a location detection service; periodically polling an ID tag associated with the medicament device using the mobile device to determine if the medicament device is within a predetermined distance from the mobile device, wherein the predetermined distance is determined based on a predefined signal strength of a signal from the ID tag to the mobile device; generating an alarm on the mobile device upon determining that the medicament device is not within the predetermined distance, wherein generating the alarm comprises playing an audible sound on the mobile device until the medicament device is within the predetermined distance from the mobile device; establishing a connection by reading the ID tag associated with the medicament device using the mobile device and periodically receiving medicament device data from the ID tag upon determining that the medicament device is present; determining a status of a use sensor of the medicament device from the received medicament device data; automatically requesting instructions for using the medicament device based on the ID tag upon determining an activated status of the use sensor; and displaying a video associated with the ID tag to a user of the mobile device, the video providing instructions for using the medicament device in accordance with approved labeling of the medicament device. Appeal 2019-001929 Application 13/907,028 3 REJECTION2 Claims 1–10 and 19–27 are rejected under 35 U.S.C. § 101 as ineligible subject matter. FINDINGS OF FACT The findings of fact relied upon, which are supported by a preponderance of the evidence, appear in the following Analysis. ANALYSIS Under 35 U.S.C. § 101, an invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. Yet, subject matter belonging to any of the statutory categories may, nevertheless, be ineligible for patenting. The Supreme Court has interpreted § 101 to exclude laws of nature, natural phenomena, and abstract ideas, because they are regarded as the basic tools of scientific and technological work, such that including them within the domain of patent protection would risk inhibiting future innovation premised upon them. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013). Of course, “[a]t some level, ‘all inventions . . . embody, use, reflect, rest upon, or apply’” these basic tools of scientific and technological work. Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 217 (2014). Accordingly, evaluating ineligible subject matter, under these judicial exclusions, involves a two-step framework for “distinguish[ing] between patents that claim the buildin[g] block[s] of human ingenuity and those that integrate the building 2 The Final Office Action (page 2) rejects claims 1–10 and 24–27 under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA), second paragraph. This rejection is withdrawn. Answer 3. Appeal 2019-001929 Application 13/907,028 4 blocks into something more, thereby transform[ing] them into a patent- eligible invention.” Id. (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 88–89 (2012)) (internal quotation marks omitted). The first step determines whether the claim is directed to judicially excluded subject matter (such as a so-called “abstract idea”); the second step determines whether there are any “additional elements” recited in the claim that (either individually or as an “ordered combination”) amount to “significantly more” than the identified judicially excepted subject matter itself. Id. at 217–18. In 2019, the USPTO published revised guidance on the application of § 101, in accordance with judicial precedent. See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50, 52 (Jan. 7, 2019) (“2019 Revised Guidance”). Under the 2019 Revised Guidance, a claim is “directed to” an abstract idea, only if the claim recites any of (1) mathematical concepts, (2) certain methods of organizing human activity, and (3) mental processes — without integrating such abstract idea into a “practical application,” i.e., without “apply[ing], rely[ing] on, or us[ing] the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” Id. at 52–55. The considerations articulated in MPEP § 2106.05(a)–(c) and (e)–(h) bear upon whether a claim element (or combination of elements) integrates an abstract idea into a practical application. Id. at 55. A claim that is “directed to” an abstract idea constitutes ineligible subject matter, unless the claim recites an additional element (or combination of elements) amounting to significantly more than the abstract idea. Id. at 56. Appeal 2019-001929 Application 13/907,028 5 The 2019 Revised Guidance stands “[i]n accordance with judicial precedent” (id. at 52), but enumerates the analytical steps somewhat differently than the Supreme Court’s Alice opinion. Step 1 of the 2019 Revised Guidance addresses whether the claimed subject matter falls within any of the statutory categories of § 101. Id. at 53–54. Step 2A, Prong One, concerns whether the claim at issue recites ineligible subject matter and, if an abstract idea is recited; Step 2A, Prong Two, addresses whether the recited abstract idea is integrated into a practical application. Id. at 54–55. Unless such integration exists, the analysis proceeds to Step 2B, in order to determine whether any additional element (or combination of elements) amounts to significantly more than the identified abstract idea. Id. at 56. In the present Appeal, as to Step 1 of the 2019 Revised Guidance, the Examiner determines that all claims in the Appeal (claims 1–10 and 19–27) are within the statutory categories of § 101. Final Action 3. With regard to the Examiner’s analysis corresponding to Step 2A, Prong One, of the 2019 Revised Guidance, we are persuaded, for the following reasons, that none of the independent claims (claims 1, 19, and 24) recites a judicial exception. The Final Office Action and Answer provide various characterizations of the independent claims. As to the first such characterization, the Examiner states: Claims 1–10, 19–27 are directed to an abstract idea of “determining whether a medicament device is in a predetermined distance from the mobile device, if it is within a predetermined distance from the mobile device, providing an instructions video to the mobile device, if it is not in a predetermined distance from the mobile device, then generating an alarm.” Appeal 2019-001929 Application 13/907,028 6 Final Action 3. See also Answer 3. The Examiner states that this position would be “explained in detail” (Final Action 3); yet, the remainder of the Final Office Action does not explain why the activities described above would constitute an abstract idea. Moreover, this description does not fit any of the abstract-idea categories employed by the Office. See 2019 Revised Guidance, 84 Fed. Reg. at 52. The foregoing description provides no “mathematical relationships, mathematical formulas or equations, [or] mathematical calculations” (id.); as such, it does not constitute a mathematical concept. The Examiner’s description also does not manifest any method of organizing human activity, as it does not exhibit any “fundamental economic principles or practices,” “commercial or legal interactions,” or “managing personal behavior or relationships or interactions between people.” Id. Nor may the Examiner’s description be characterized as a mental process — i.e., a “concept[ ] performed in the human mind” (id.) — particularly as to the features in the Examiner’s description of “providing an instructions video to the mobile device” and “generating an alarm” (Final Action 3). The Examiner likens the claimed subject matter to another abstract- idea characterization, based upon the following paraphrasing of certain limitations of claim 1: [D]etermining a physical location of a mobile device, polling an ID tag associated with the medicament device using a mobile device to determine if the medicament device [is] within a predetermined distance from the mobile device, generating an alarm on the mobile device upon determining that the medicament device is not within a predetermined distance from the mobile device, establishing a connection by reading the ID tag associated with the medicament device using the mobile device, determining status of a use sensor of the medicament Appeal 2019-001929 Application 13/907,028 7 device from the received medicament device data, automatically requesting instructions for using the medicament device based on the ID tag upon determining an activated status of the use sensor, and displaying an instructions video associated with the ID tag to a user of the mobile device. Final Action 3–4. According to the Examiner, these limitations “correspond to concepts identified as abstract ideas by the courts, such as ‘an idea of itself,’” for example “the concept of ‘delivering user-selected media content to [a] portable device.’” Id. at 4 (citing Affinity Labs of Tex., LLC v. Amazon.com Inc., 838 F.3d 1266 (Fed. Cir. 2016)). Yet, the referenced abstract-idea characterization, from the Affinity Labs decision, does not fairly represent the purportedly corresponding language of claim 1. In particular, the characterization of “delivering user- selected media content to [a] portable device” (id.) fails to account for numerous of the identified claim features that appear in claim 1, for example, such as “determining a physical location of a mobile device,” “determin[ing] if the medicament device is within a predetermined distance from the mobile device,” “generating an alarm on the mobile device upon determining that the medicament device is not within the predetermined distance,” and “determining a status of a use sensor of the medicament device from the received medicament device data.” Thus, the Examiner’s analysis oversimplifies the substance of claim 1, “by looking at [it] generally and failing to account for the specific requirements of the claim[ ].” McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1313 (Fed. Cir. 2016) (citing In re TLI Commc’ns LLC Patent Litig., 823 F.3d 607, 611 (Fed. Cir. 2016) and Diamond v. Diehr, 450 U.S. 175, 189 n.12 (1981)). Therefore, we agree with the Appellant’s argument (see Appeal Br. 11–14), insofar as Appeal 2019-001929 Application 13/907,028 8 the identified subject matter of claim 1 does not recite an abstract idea corresponding to “delivering user-selected media content to [a] portable device” in Affinity Labs, 838 F.3d at 1269. A similar problem affects the Examiner’s further characterization of claim 1. In the Final Office Action, the Examiner refers to the following excerpt of the claim language: establishing a connection by reading the ID tag associated with the medicament device using the mobile device and periodically receiving medicament device data from the ID tag upon determining that the medicament device is present; determining a status of a use sensor of the medicament device from the received medicament device data; automatically requesting instructions for using the medicament device based on the ID tag upon determining an activated status of the use sensor; and displaying a video associated with the ID tag to a user of the mobile device, the video providing instructions for using the medicament device in accordance with approved labeling of the medicament device. Final Action 4. The foregoing claim language3 is said to correspond to the concept of “collecting information, analyzing it, and displaying certain results of the collection and analysis,” which was called an abstract idea in Electric Power Grp., LLC v. Alstom, S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016). Id. In the Answer, the Examiner invokes the same characterization from Electric Power Group, stating that the following excerpt of claim 1 also corresponds to the concept of “collecting information, analyzing the information, and displaying certain results of the collection and analysis”: [D]etermining a physical location of a mobile device using a location detection service; periodically polling an ID tag 3 The Examiner might rely upon the underlined portions only, but the reason for such underlining is not explained in the Final Office Action. Including or excluding the non-underlined text has no effect upon the analysis herein. Appeal 2019-001929 Application 13/907,028 9 associated with the medicament device using the mobile device to determine if the medicament device is within a predetermined distance from the mobile device; generating an alarm on the mobile device upon determining that the medicament device is not within the predetermined distance; determining a status of a use sensor of the medicament device from the received medicament device data; automatically requesting instructions for using the medicament device based on the ID tag upon determining an activated status of the use sensor. Answer 5. However, neither of the identified excerpts from claim 1 aligns with Electric Power Group’s activities of collecting, analyzing, and displaying data. Significantly, the claims addressed in Electric Power Group are remarkable for their lack of detail, particularly as to what constitutes the claimed “analyzing” and “displaying.” Elec. Power Grp., 830 F.3d at 1352. The Federal Circuit points out that the Electric Power Group claims fail to recite what type of “analy[sis]” would be performed and how this might be accomplished, nor did the claims delineate any particular technique or instrumentality for “displaying” the results: Though lengthy and numerous, the claims do not go beyond requiring the collection, analysis, and display of available information in a particular field, stating those functions in general terms, without limiting them to technical means for performing the functions that are arguably an advance over conventional computer and network technology. Id. at 1351. See also id. at 1355 (“The claims in this case do not even require a new source or type of information, or new techniques for analyzing it.”) (citations omitted). Additionally, our reviewing court explains: a large portion of the lengthy claims is devoted to enumerating types of information and information sources available within Appeal 2019-001929 Application 13/907,028 10 the power-grid environment. But merely selecting information, by content or source, for collection, analysis, and display does nothing significant to differentiate a process from ordinary mental processes, whose implicit exclusion from § 101 undergirds the information-based category of abstract ideas. Id. at 1355. Accordingly, the court in Electric Power Group, in describing the shortcomings of the claims at issue in that case, repeatedly invokes the caveat “without more,” in order to emphasize the unusually spare nature of the claims before the court — in regard to the very features that would need to be more fulsome, in order to avoid the pitfall of subject-matter ineligibility. Id. at 1354 (“[W]e have treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category”; “[W]e have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis”; “Most obviously, limiting the claims to the particular technological environment of power-grid monitoring is, without more, insufficient to transform them into patent-eligible applications of the abstract idea at their core.”) (emphasis added). In contrast, each of the Examiner’s selected excerpts from claim 1, of the present Appeal, contains more than mere unarticulated “analyzing” feature, which the Federal Circuit described in Electric Power Group. Instead, the claim language referenced on page 4 of the Final Office Action recites, for example, “determining a status of a use sensor of the medicament device from the received medicament device data.” Similarly, the claim language referenced on page 5 of the Answer recites, for example, Appeal 2019-001929 Application 13/907,028 11 “determine if the medicament device is within a predetermined distance from the mobile device.” Therefore, we agree with the Appellant’s argument (see Appeal Br. 15–18, Reply Br. 6–7), insofar as the identified subject matter of claim 1 does not recite an abstract idea corresponding to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” as in Electric Power Group, 830 F.3d at 1353. The Examiner’s comparison of claim 1 to the subject matter claimed in Electric Power Group relies upon an oversimplified understanding of the claim language at issue. See McRO, 837 F.3d at 1313. Because the Examiner relies on the analysis, discussed above, as to all the independent claims, we are persuaded of error in the rejection of independent claims 1, 19, and 24, without needing to address Step 2A, Prong Two, or Step 2B of the 2019 Revised Guidance. Accordingly, we do not sustain the rejection of claims 1–10 and 19–27 under 35 U.S.C. § 101. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–10, 19–27 101 Eligibility 1–10, 19–27 REVERSED Copy with citationCopy as parenthetical citation