Sam Popinchalk

Patent Trials and Appeals BoardDec 7, 2021

2021000992 (P.T.A.B. Dec. 7, 2021)

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. 13/675,306 11/13/2012 Sam Popinchalk 079220-480957 3842 27148 7590 12/07/2021 POLSINELLI PC PO Box 140310 KANSAS CITY, MO 64114-0310 EXAMINER EBRAHIM, NABILA G ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 12/07/2021 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): patentdocketing@polsinelli.com rendsley@polsinelli.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SAM POPINCHALK1 Appeal 2021-000992 Application 13/675,306 Technology Center 1600 Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to methods of diagnosing or characterizing lesions in a peripheral nerve, which have been rejected as obvious.2 We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant identifies the real party in interest as Sam Popinchalk. Appeal Br. 2. “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. 2 In the Final Action (mailed March 24, 2020), the Examiner also stated, without explanation, that claims 1 and 21 were rejected as indefinite. The Examiner’s Answer does not mention this issue. We therefore consider the “rejection” in the Final Action to be unintentional. If it was intentional, we reverse it because the Examiner provided no reasoned basis for the rejection. Appeal 2021-000992 Application 13/675,306 2 STATEMENT OF THE CASE “Currently, in the setting of acute injury, there exists no method to reliably distinguish peripheral nerve injuries that will spontaneously resolve from those that will require surgical intervention to restore function.” Spec. ¶ 5. “The current method of differentiating injuries that will regenerate . . . with those that require surgical intervention to repair . . . is an observation period that might last several months, e.g., a three to six month observation period.” Id. ¶ 34. The Specification discloses a “method . . . to distinguish lesions where the blood-nerve barrier (‘BNB’) remains intact, and therefore has greater self-regeneration potential[,] from lesions where the connective tissue layers comprising the BNB are disrupted, and therefore require surgical intervention.” Id. ¶ 11. “Early intervention translates to better functional outcomes.” Id. ¶ 5. Claims 1–10, 13, 15, 16, and 18–24 are on appeal. Claim 1, reproduced below, is illustrative (emphasis added): 1. A method to characterize peripheral nerve lesions by detecting blood-nerve barrier permeability, the method including the steps of: introducing a chemical agent to a peripheral nerve having a blood-nerve barrier to characterize peripheral nerve lesions, the chemical agent operable to interact with an epitope within the blood-nerve barrier, detecting blood-nerve barrier permeability by analyzing the peripheral nerve to detect an amount of the chemical agent at a site of the blood-nerve barrier permeability, the blood-nerve barrier permeability caused by a lesion, wherein, Appeal 2021-000992 Application 13/675,306 3 the chemical agent (i) does not interact with the epitope unless the blood-nerve barrier is permeable and allows the epitope to be exposed to the chemical agent, and (ii) is operable to localize at the site of the blood-nerve barrier permeability, and the method does not include modification of the blood- nerve barrier permeability. OPINION Claims 1–10, 13, 15, 16, and 18–24 stand rejected under 35 U.S.C. § 103(a) as obvious based on Neuwelt,3 Seneviratne,4 and Zemlan.5 Final Action 5. The Examiner finds that Neuwelt teaches a “method for diagnosing and characterizing brain lesions which involves, injecting a chemical agent . . . at a location outside the blood-brain barrier (BBB) where the first chemical agent is capable of increasing the permeability of the BBB.” Id. The Examiner finds that Neuwelt’s method also includes “administering a second chemical agent to said animal at a location outside the BBB wherein said second chemical agent is capable of binding preferentially to a brain lesion and of passing through the animal’s blood brain barrier to the brain lesion.” Id. The Examiner notes that claim 1 “require[s] that the method does not include modification of the BBB [sic, BNB] permeability,” but reasons that Neuwelt “teaches that the BBB may become increasingly permeable during the development or onset of brain tumors, vascular lesions, or abscesses. . . . 3 US 5,059,415, issued October 22, 1991. 4 K. N. Seneviratne, Permeability of blood nerve barriers in the diabetic rat, J. of Neurology, Neurosurgery, & Psychiatry 35:156–62 (1972). 5 US 6,589,746, issued July 8, 2003. Appeal 2021-000992 Application 13/675,306 4 The tumors and other lesions would modify the BBB without a first chemical agent in cases such as brain-trauma, -tumors,” etc. Id. at 6. The Examiner acknowledges that “Neuwelt did not disclose practicing the method on the blood nerve barrier of a peripheral nerve.” Id. at 8. The Examiner finds, however, that “Seneviratne . . . teaches that in sectioned or crushed nerve . . . , there was a rapid and marked accumulation of extravascular labeled protein at the site of the lesion.” Id. The Examiner therefore concludes that “according to Seneviratne, the BNB has higher permeability when the injury was a sectioned and/or crushed-nerve . . . and thus the method taught by Neuwelt would not have needed the step of modifying the nerve permeability.” Id. at 9. The Examiner concludes that it would have been obvious to exclude the step required to modify the permeability of blood-brain barrier taught in Neuwelt since Neuwelt taught that there were situations when the BNB [sic, BBB] permeability was modified by the lesion itself such as in the case of a tumor[]; the person having ordinary skill would use the guidance provided in Seneviratne in cases of analyzing blood- nerve barrier because the latter states that in cases such as sectioned or crushed nerve injury, the permeability of the BNB increases. Id.6 Appellant argues that “the cited references . . . do not disclose the presently claimed ‘. . . method [that] does not include modification of the blood-nerve barrier permeability.’” Appeal Br. 9. Appellant argues that “Neuwelt is limited to a process of deliberately increasing permeability of the BBB via chemical modification in [an] attempt to remedy imaging 6 The Examiner relies on Zemlan only with respect to dependent claim 7 (Final Action 10–11), so we need not further discuss Zemlan. Appeal 2021-000992 Application 13/675,306 5 problems caused by impermeability of the BBB,” and “one of ordinary skill in the art would never modify Neuwelt to not increase permeability of the BBB because increasing permeability of the BBB is Neuwelt’s primary purpose and principle [of] operation.” Id. at 9–10. Appellant also argues that “Neuwelt further teaches that even in the presence of . . . brain lesions, there have been issues with permeability of diagnostic imagining [sic] agents through the BBB. . . . In fact, these issues are exactly what the method disclosed in Neuwelt attempts to address.” Id. at 10. Thus, Appellant argues, “[i]f one of skill were relying upon Neuwelt, they would have understood that Neuwelt taught that modification of the BBB, even in the presence of a lesion, was necessary to allow for permeability.” Id. at 11. And, Appellant argues, “Seneviratne does not provide any teachings or disclosures that would suggest disclosures relating to the BNB are related to the BBB or vice versa.” Id. at 10. We agree with Appellant that the Examiner has not persuasively shown that it would have been obvious to modify Neuwelt’s method by omitting the step of increasing the permeability of the blood-brain barrier (BBB) or, by extension, the blood-nerve barrier (BNB). Neuwelt discloses “an improved diagnostic imaging procedure for determining the size and character of brain lesions.” Neuwelt 4:6–8. Neuwelt uses “[t]he term ‘brain lesions’ . . . [to] encompass malignant tumors, CNS infections, brain abscesses, cerebro-vascular disorders, and even degenerative disorders such as Parkinson’s disease and Alzheimer’s disease.” Id. at 4:8–12. Neuwelt’s method includes two steps: “Initially, a chemical agent designed to increase the permeability of the BBB is administered. . . . As a result, BBB permeability is greatly increased.” Id. at 4:24–25, 4:45–46. Appeal 2021-000992 Application 13/675,306 6 “Subsequent to BBB modification, a second chemical agent is administered which binds specifically and exclusively to lesion tissues.” Id. at 4:52–54. As the Examiner has pointed out, Neuwelt also discloses that “recent research has shown that the BBB may become increasingly permeable during the development or onset of brain tumors, vascular lesions, or abscesses.” Id. at 2:4–7. The Examiner notes that “Neuwelt’s disclosure includes tumors as one of the disclosed ‘brain lesions’ being discussed.” Final Act. 6. The Examiner concludes that “[t]he tumors and other lesions would modify the BBB without a first chemical agent in cases such as brain- trauma, -tumors,” etc. Id. We do not agree with the Examiner’s conclusion. The fact that Neuwelt (a) indicates that BBB permeability is increased during development of brain tumors, abscesses, and vascular lesions, yet (b) includes a step of administering an agent to increase BBB permeability in its method of diagnosing brain lesions—including tumors, abscesses, and cerebro-vascular disorders—is evidence that the naturally occurring increase in permeability is not sufficient to allow passage of Neuwelt’s diagnostic agent through the BBB. For its part, Seneviratne discloses only that crushing or sectioning of peripheral nerve caused “accumulation of extra-vascular labelled protein at the site of the lesion.” Seneviratne 156, right col. Seneviratne does not address what effect, if any, the type of lesions discussed by Neuwelt have on the blood-nerve barrier in peripheral nerves. In summary, the Examiner has not persuasively shown that a skilled artisan would have found it obvious to modify Neuwelt’s method by omitting the initial step of administering an agent that increases the Appeal 2021-000992 Application 13/675,306 7 permeability of either the blood-brain barrier or the blood-nerve barrier. We therefore reverse the rejection of claims 1–10, 13, 15, 16, and 18–24 under 35 U.S.C. § 103(a) based on Neuwelt, Seneviratne, and Zemlan. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–10, 13, 15, 16, 18–24 103(a) Neuwelt, Seneviratne, Zemlan 1–10, 13, 15, 16, 18–24 REVERSED