Victor PedroDownload PDFPatent Trials and Appeals BoardFeb 1, 20212020003459 (P.T.A.B. Feb. 1, 2021) 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. 14/284,864 05/22/2014 Victor M. Pedro 3958/1002 9160 2101 7590 02/01/2021 Sunstein LLP 100 High Street Boston, MA 02110-2321 EXAMINER JENNESS, NATHAN JAY ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 02/01/2021 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): usptomail@sunsteinlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte VICTOR M. PEDRO Appeal 2020-003459 Application 14/284,864 Technology Center 3700 Before BENJAMIN D. M. WOOD, BRANDON J. WARNER, and LEE L. STEPINA, Administrative Patent Judges. WOOD, 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 reject claims 1, 4, 7, 10, and 15, which constitute all the claims pending in this application. See Final Act. 1. Claims 2, 3, 5, 6, 8, 9, and 11–14 have been cancelled. An oral hearing in accordance with 37 C.F.R. § 41.47 was held on January 14, 2021, a transcript of which will be 1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Rhode Island Integrated Medicine. Appeal Br. 3. Appeal 2020-003459 Application 14/284,864 2 entered into the record in due course. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. CLAIMED SUBJECT MATTER The claims are directed to a method for treating a subject having post- concussion syndrome. Sole independent claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method of treating a subject having post-concussion syndrome (PCS), the method providing a protocol comprising: identifying post-concussion syndrome in the subject; selecting a plurality of distinct postures, to be sequentially assumed by the subject, from a posture set of walking, standing, sitting, and supine; selecting a plurality of distinct stimuli, to which the subject will be sequentially subjected, from a stimulus set of TENS, non-painful heat, non-painful cold, visual, occulomotor stimulation, crude touch, olfactory stimulation, vestibular stimulation, and auditory stimulation; selecting an autonomic physiological response parameter, to be quantitatively measured as of when the subject is subjected to each selected stimulus, from the response parameter set of oxygen saturation, heart rate, pupillary response, blood pressure, sweat production, pseudomotor activity, and respiration; having the subject sequentially assume each selected posture; in each of the selected postures, subjecting the subject to each of the selected stimuli sequentially, quantitatively measuring the selected autonomic physiological response parameter as of when the subject has been subjected to each of the selected stimuli, and recording each of the quantitative measures in association with the corresponding posture and stimulus; analyzing the recorded quantitative measures to identify the posture with respect to which the subject exhibits a least Appeal 2020-003459 Application 14/284,864 3 amount of dysfunction relative to a statistical norm, and identify the stimulus with respect to which the subject exhibits a least amount of dysfunction relative to the statistical norm when in the identified posture; repeatedly: subjecting the subject to the identified stimulus while the subject is in the identified posture and while using an instrument to provide a quantitative measure of the selected autonomic physiological response parameter as of each instance when the subject has been subjected to the identified stimulus, and recording each of the quantitative measures relating to each such instance, until the recorded quantitative measures indicate that a desired endpoint physiological condition has been achieved approaching normalcy relative to the statistical norm; upon achievement of the desired endpoint physiological condition, having the subject assume a posture different from the identified posture, and, when the subject is in such posture, subjecting the subject to one of the selected stimuli while using the instrument to provide a quantitative measure of the selected autonomic physiological response parameter and recording the quantitative measure for the different posture; analyzing the recorded quantitative measure for the different posture to determine whether there is a dysfunction in response of the subject, relative to a further statistical norm, to the one of the selected stimuli; and upon existence of such a dysfunction, repeatedly subjecting the subject to the one of the selected stimuli at the different posture until a further desired endpoint physiological condition is achieved approaching normalcy relative to the further statistical norm, wherein the post-concussion syndrome is associated with at least one symptom selected from the group consisting of headaches, dizziness, neck pain, stiff neck, cold sweats, excessive eye sensitivity to light and combinations thereof, the treatment resulting in a decrease in the at least one symptom, and wherein the foregoing protocol promotes thalamocortical pathways within the brain. Appeal 2020-003459 Application 14/284,864 4 REJECTION Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis 1, 4, 7, 10, 15 101 Eligibility OPINION I. PRINCIPLES OF LAW To determine whether a claim falls within a judicially recognized exception to patent eligibility under 35 U.S.C. § 101, we apply the two-step framework set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and reaffirmed in Alice Corporation Proprietary LTD. v. CLS Bank International, 573 U.S. 208 (2014). For the first Alice step (Step 2A of the USPTO’s Patent Subject Matter Eligibility guidance, MPEP § 2106), we determine whether the claims at issue are directed to a patent-ineligible concept such as an abstract idea, law of nature, or natural phenomenon. Alice, 573 U.S. 208 (citing Mayo, 566 U.S. at 78– 79). If so, we advance to the second Alice step (Step 2B of the USPTO’s Patent Subject Matter Eligibility guidance) where “we consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application” of the otherwise patent-ineligible concept. Id. (quoting Mayo, 566 U.S. 78–79). We also follow the USPTO’s additional guidance on applying Step 2A. See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Appeal 2020-003459 Application 14/284,864 5 Reg. 50 (Jan. 7, 2019) (“Revised Guidance”).2 The Revised Guidance establishes a “two-prong inquiry” for determining whether a claim is directed to a judicial exception. Id. at 54. In prong one, we determine whether the claim recites a judicial exception, such as a law of nature, natural phenomenon, or abstract idea. Id. If so, we look to whether the claim recites additional elements that integrate the judicial exception into a practical application. Id. at 50. Thus, a claim is directed to a judicial exception only if the claim recites a judicial exception and does not integrate that exception into a practical application. Id. Relevant to this case, the Revised Guidance instructs that an additional limitation that “applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition” may integrate the judicial exception into a practical application. Id. at 55. If we determine that the judicial exception is not integrated into a practical application, we proceed to Step 2B and determine whether the claim adds a specific limitation beyond the judicial exception that is not well-understood, routine, and conventional activity in the field, or, alternatively, whether the claim simply appends well-understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Id. at 56. II. DISCUSSION A. The Examiner’s and Appellant’s Positions For Step 2A, Prong 1, the Examiner finds that: 2 Available at https://www.govinfo.gov/content/pkg/FR-2019-01- 07/pdf/2018-28282.pdf. Appeal 2020-003459 Application 14/284,864 6 the claims describe the natural correlation of postures and stimuli to autonomic response and determining a desired endpoint which involve the mental process of forming a judgment/observation/evaluation/opinion of the amount of dysfunction present in a human subject and at to when an endpoint physiological condition is achieved as well as organizing human activity by having a human subject following instructions presented by a physician/himself. Final Act. 9. For Step 2A, Prong 2, the Examiner finds that the claims are not considered to be directed towards a particular treatment . . . The exception/natural correlation is defined as the treatment, and the remaining limitations are considered nominal or field of use/extra-solution activity because they merely indicate autonomic responses to stimuli should be evaluated on a subject identified as having post-concussion syndrome. The claims do not contain specific steps for identifying post-concussion syndrome and do not describe a particular treatment. The claims merely recite a desired endpoint physiological condition. Again, this indicates that any non-particular “treatment” resulting in a return toward “normal” autonomic responses, e.g. lowering heart rate from an elevated state, results in the treatment of post-concussion syndrome. Id. at 9–10. For Step 2B, the Examiner finds that “[t]he claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are not required to be performed on a particular machine, do not transform an article, describe a naturally occurring correlation, and relate to a general concept.” Id. at 7. Appellant responds that “[b]ecause the claims at issue on appeal are directed to a method of treatment that practically applies a natural relationship to effect a particular treatment for a medical condition, they are patent eligible.” Appeal Br. 7 (citing Vanda Pharm. Inc. v. West-Ward Pharm., 887 F.3d 1117, 1135 (Fed. Cir. 2018)). Appellant asserts that Appeal 2020-003459 Application 14/284,864 7 claim 1 recites a series of treatment steps to treat post-concussion syndrome. Id. According to Appellant, the claimed steps “have a transformative effect on the brain,” e.g., “promot[ing] thalamocortical pathways within the brain.” Id. at 8. A. Analysis 1. Step 2A, Prong 1 We agree with the Examiner that claim 1 recites a judicial exception. For example, the steps of “selecting a plurality of distinct postures” from the claimed “posture set,” “selecting a plurality of distinct stimuli” from the claims “stimulus set,” and “selecting an autonomic physiological response parameter from a “response parameter set” concern judgments that can be performed in the human mind, and therefore fall within the mental-process grouping of abstract ideas. Revised Guidance, 84 Fed. Reg. at 52. Further, the steps directed to having the subject assume various postures relate to managing personal behavior, which falls within the certain-methods-of- organizing-human-activity grouping of abstract ideas. Id. Accordingly, we proceed to Prong 2 to determine whether additional elements integrate the judicial exception into a practical application of the judicial exception. 2. Step 2A, Prong 2 As noted above, the Revised Guidance states that an element that “applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition” may integrate a recited judicial exception into a practical application. The Revised Guidance cites in part to Vanda in support of this proposition. In Vanda, the claims at issue involved a method of treating persons with schizophrenia, where the method first required performing a genetic test to determine the person’s ability to Appeal 2020-003459 Application 14/284,864 8 metabolize iloperidone and other drugs (i.e., the patient’s “CYP2D6 metabolizer genotype”), and then administering a particular dose of iloperidone based on the results of the test; a lower dose of iloperidone is administered to patients with lower CYP2D6 activity comparing with those with normal CYP2D6 activity to avoid a potentially harmful side effect of the drug. Vanda, 887 F.3d at 1121, 1134. The court determined that the claims “are not directed to patent-ineligible subject matter” because they included specific steps to treat a particular disease. Id. at 1134. The court contrasted Vanda’s claims with those at issue in Mayo, which, even though they recited administering a drug to a patient, they did so only as a diagnostic method “based on the ‘relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of [the] drug will prove ineffective or cause harm.’” Id. (quoting Mayo, 566 U.S. at 77). The court characterized Mayo’s claims as directed to the “entirely natural process” of the body’s metabolizing of the drug. Id. (citing Mayo, 566 U.S. at 77). We agree with Appellant that claim 1 is drawn to a method of treatment rather than a diagnostic method, and therefore is patent eligible under Vanda. While the claimed method requires measuring a subject’s autonomic physiological responses to various stimuli while the patient assumes various postures (to determine an optimal combination of posture and stimulus for treatment), the claim also requires that the patient be repeatedly subjected to the selected stimulus while in the selected posture until the autonomic physiological response changes to a desired endpoint physiological response, i.e., until the autonomic response “approach[es] normalcy relative to [a] statistical norm.” Appeal Br. 16–17 (claims app.). Appeal 2020-003459 Application 14/284,864 9 The Specification explains that “different body postures affect the autonomic nervous system differently, and therefore various external stimuli may have different therapeutic efficacies when a patient or subject is in each body posture.” Spec. ¶ 8. Repeatedly subjecting the patient to the selected stimulus while in the selected posture “stimulates the nervous system,” thereby promoting “the formation of pathways that help transfer information throughout the brain” to improve “overall brain function.” Id. The repeated application of the stimulus to change an autonomic response, as claimed, distinguishes this claim from one that would merely measure a pre-existing autonomic response. The Examiner asserts that the claims at issue here are distinguishable from the claims found to be patent eligible in Vanda because “the treatment steps in the present claim are identical to the diagnostic steps.” Final Act. 3. We disagree. As stated above, the diagnostic steps are performed to select the optimum combination of posture and stimulus based on pre-treatment autonomic responses to multiple stimuli as the patient alternates between multiple postures; conversely, the treatment steps then repeatedly subject the patient to the selected stimuli while in the selected posture to eventually change the autonomic response, which evidences the formation of “thalamocortical pathways within the brain.” Appeal Br. 18 (claims app.). The Examiner further asserts that the present claims are distinguishable from Vanda because they “involve only natural correlations invoked . . . by stimuli received by humans in everyday life.” Final Act. 3. It is true that, for example, a person may experience “non-painful cold” while “sitting.” See Appeal Br. 16 (claims app.). But, again, claim 1 goes beyond simply measuring a response to a stimulus in a particular posture, Appeal 2020-003459 Application 14/284,864 10 and instead includes steps designed to change a person’s response to a stimulus. The Examiner further argues that “[t]he treatment steps may be applied entirely by hand.” Final Act. 3. It is true that the claimed set of stimuli includes “crude touch,” which arguably can be performed by hand. But the Examiner has not provided legal support for the notion that patent- eligible treatment methods must involve a pharmaceutical, or at least cannot be performed by hand. To the extent that this argument is a reflection of the Examiner’s determination that the claims fail the machine-or-transformation test for patent eligibility (Final Act. 4), we note that a claim may be patent eligible even if it fails this test. Bilski v. Kappos, 561 U.S. 593, 604 (2010). The Examiner also asserts that the claims “do not require a particular end result to define the treatment i.e. treatment is considered rendered if there is any movement of an autonomic response towards a statistical norm.” Final Act. 3. We disagree that the claims do not require an end result; on the contrary, they require application of the selected stimulus until an autonomic physiological response changes such that it approaches “normalcy relative to [a] statistical norm.” Appeal Br. 16 (claims app.). We further note that the representative claim in Vanda does not require any particular end result (Vanda, 887 F.3d at 1121), and was nonetheless determined to be patent eligible. CONCLUSION The Examiner’s rejection is reversed. Appeal 2020-003459 Application 14/284,864 11 DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 4, 7, 10, 15 101 Eligibility 1, 4, 7, 10, 15 REVERSED Copy with citationCopy as parenthetical citation