CHIH-YUNG LIN

Patent Trials and Appeals BoardMar 2, 2021

2020002014 (P.T.A.B. Mar. 2, 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. 15/323,736 01/04/2017 CHIH-YUNG LIN AJ6076CN_P2808-US 7087 108266 7590 03/02/2021 PyPat IP Services 19925 Stevens Creek Blvd., Ste. 100, Cupertino, CA 95014 EXAMINER DECK, JASON A ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 03/02/2021 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): ahuang@pypat.com bonnielee@pypat.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte CHIH-YUNG LIN1 ____________ Appeal 2020-002014 Application 15/323,736 Technology Center 1600 ____________ Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 We use the word “Appellant” to refer to “Applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Chih-Yung Lin, the named inventor, as the real party-in-interest. App. Br. 3. Appeal 2020-002014 Application 15/323,736 2 SUMMARY Appellant files this appeal under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 1–3, 5, and 7–10 as unpatentable under 35 U.S.C. § 103 as being obvious over Lasser (US 2013/0071490 A1, March 21, 2013) (“Lasser”). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellant’s claimed invention is directed to an aqueous tissue clearing solution for making biological material transparent. Abstr. REPRESENTATIVE CLAIM Independent claim 1 is representative of the claims on appeal and recites: 1. An aqueous solution comprising: a first active compound of formula (I) ; and a second active compound of formula (II) Appeal 2020-002014 Application 15/323,736 3 ; a sufficient amount of a solvent that is water or a salt balanced buffer solution for dissolving the first and second active compounds therein and thereby forming the aqueous solution; wherein: R1, R2, R3, and R4 are independently H, or C1–6 alkyl substituted with at least two -OH; R5 is -CH2OCH3 or C1–3 alkyl optionally substituted with at least one -OH; R6 and R7 are independently acetyl or C1–3 alkyl; R8 is H or C1–3 alkyl optionally substituted with at least two -OH; X1, X2, and X3 are independently a halogen selected from the group consisting of Cl, Br, and I; Y is or C1–3 alkyl substituted with at least one -OH; the pH of the aqueous solution is less than 11; the osmolality of the aqueous solution is from 1,700 to 3,500 mOSm/L; Appeal 2020-002014 Application 15/323,736 4 the first active compound of formula (I) and the second active compound of formula (II) are respectively present at a concentration of at least 10% (w/v) in the aqueous solution; and the aqueous solution is suitable for rendering a biomaterial transparent. App. Br. 14–15. ISSUES AND ANALYSIS We adopt the Examiner’s findings, reasoning, and conclusion that the claims on appeal are prima facie obvious over the cited prior art. We address the arguments raised by Appellant below. Issue 1 Appellant argues that the Examiner erred because the cited prior art does not teach or suggest the limitations of claim 1 reciting: (1) “the osmolality of the aqueous solution is from 1700 to 3500 mOsm/L,” 2 and (2) “the aqueous solution is for rendering a biomaterial transparent.” App. Br. 10–11 (emphasis omitted). 2 Appellant refers to “osmolality” as recited by claim 1. However, the claim further recites mOsm/L, which are the units for osmolarity (osmolarity refers to the number of solute particles per 1 liter of solvent, whereas osmolality is the number of solute particles in 1 kg of solvent). It therefore appears that “osmolality” in the claim may be a typographical error as the Specification consistently refers to “osmolarity.” See Spec. ¶¶ 7, 27, 31, 44, original claim 1. For the sake of consistency, we will refer to osmolarity throughout the decision. Appeal 2020-002014 Application 15/323,736 5 Analysis The Examiner finds that Lasser teaches a composition containing a mixture of active compounds including iopamidol (a compound of formula I) and iodixanol (a compound of formula II), and water as a solvent. Ans. 3 (citing Lasser claim 22, ¶¶ 115, 154 (Example 12)). The Examiner acknowledges that Lasser does not teach the instantly claimed composition, including the claimed osmolarity. See id. However, the Examiner concludes that a person of ordinary skill in the art would have been motivated to make the claimed composition with a reasonable expectation of success in view of Lasser. See id. at 3–5. Specifically, the Examiner finds that one of ordinary skill in the art would have modified Lasser’s compositions to include at least 10% each of iopamidol and iodixanol by routine optimization because Lasser teaches combinations of active agents, and a concentration of up to 80% active agent. Ans. 4 (citing Lasser ¶ 154 (Example 12)). The Examiner finds that one of ordinary skill in the art would have made Lasser’s compositions at or near a neutral pH, including a pH of 6–9, because Lasser teaches administering compositions for various conditions requiring a neutral pH. Id. at 5. The Examiner finds that one of ordinary skill in the art would have routinely optimized the osmolarity to a range of 1,700 to 3,500 mOsm/L because Lasser teaches varying the amounts of active agents and additives that would have provided a range of different osmolarities. Id. at 5–6. For example, the Examiner finds that a composition containing up to 80% iodipamide as taught by Lasser, including additional components of a commercially available iodipamide composition (Cholografin® meglumine Appeal 2020-002014 Application 15/323,736 6 as cited by Appellant)3, would have resulted in an osmolarity of about 1680 mOsm/L. Id. at 8. The Examiner further addresses the difference in use between the claimed composition and Lasser’s composition. See Ans. 9–10. The Examiner finds that “the instant claims are drawn to a composition, and not a method of use.” Id. at 10. Accordingly, the Examiner does not give patentable weight to the intended use of “rendering a biomaterial transparent.” Id.; see also Final Act. 9. Because the claimed intended use does not distinguish the prior art, the Examiner concludes that the claimed composition would have been prima facie obvious over Lasser’s teachings. Id. Appellant argues that Lasser does not teach all of the claimed limitations, particularly an aqueous solution for rendering a biomaterial transparent, the solution having an osmolarity within the range of 1700 to 3500 mOsm/L. App. Br. 11. Appellant argues that Lasser instead teaches a pharmaceutical composition for treating inflammation and having an osmolarity within the range of 97 to 627 mOsm/L. Id. at 13. We are not persuaded by Appellant’s argument. As an initial matter, we address the intended use of the composition as “suitable for rendering a biomaterial transparent.” The intended use of the claimed aqueous solution does not add patentable weight to the claims because patentability of composition claims depends on the claimed composition, not on the use or purpose of that composition. Catalina Mktg. Int’l, Inc. v. Coolsavings.com, 3 The Cholografin® meglumine package insert was made of record on Nov. 7, 2018. Appeal 2020-002014 Application 15/323,736 7 Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Accordingly, we are not persuaded that the Examiner erred in finding that the claimed intended use does not distinguish the prior art. We next address the difference in osmolarity. The Examiner found that although Lasser does not teach the claimed range, a person of ordinary skill in the art would have made a composition with an overlapping range during routine optimization of Lasser’s composition. See Ans. 3–5. The Examiner correctly identified that osmolarity is the result of numerous components of the composition, and not limited to the concentration of iopamidol and iodixanol as argued by Appellant. See id. at 6–9; see App. Br. 13. Moreover, the Examiner found that optimizing Lasser’s compositions to include amounts of known solutes in a composition containing the same class of active agent results in compositions having a similar osmolarity, i.e., 1680 mOsm/L as compared to 1700 mOsm/L. See Ans. 8 (citing Cholografin® meglumine package insert). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (C.C.P.A. 1955). Appellant has provided no evidence that the claimed range is critical in that it produces a new and unexpected result as compared to the prior art range. See id.; see also In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (holding that “a prima facie case of obviousness exists when the claimed range and the prior art range do not overlap but are close enough such that one skilled in the art would have expected them to have the same properties”). Accordingly, we are not persuaded that the Examiner erred in concluding that the claimed composition would have been prima facie obvious over Lasser. Appeal 2020-002014 Application 15/323,736 8 Issue 2 Appellant argues that the Examiner failed to consider the entirety of Lasser, including language that would lead away from the claimed invention. App. Br. 11–12. Analysis Appellant argues that Lasser describes the claimed active agents as X-ray contrast materials used to opacify tissue. App. Br. 12 (citing Lasser ¶ 56). Appellant argues that Lasser therefore teaches the opposite use of the active agents from the intended use of the claimed composition, viz. to render tissue transparent. Id. Appellant argues that a person of ordinary skill in the art would not have been motivated to modify Lasser’s composition for tissue clearing, and thus would have no reason to optimize the osmolarity to the claimed range. Id. at 12–13. We are not persuaded. As we have explained supra, the intended use of the composition does not distinguish the prior art. Moreover, that Lasser teaches a different use for the same active agents does not negate the motivation to optimize the osmolarity of Lasser’s composition. See Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362, 1368 (Fed. Cir. 2012) (holding that “the motivation to modify a prior art reference to arrive at the claimed invention need not be the same motivation that the patentee had.”). Rather, the Examiner established that a person of ordinary skill in the art would have optimized the osmolarity of Lasser’s composition simply by combining the active agents with known amounts of known excipients. Because the objective reach of the claimed composition extends to Lasser’s Appeal 2020-002014 Application 15/323,736 9 compositions, the claimed composition would have been obvious over Lasser’s teachings. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007) (“In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103”). We consequently conclude that Appellant’s arguments are insufficient to overcome the Examiner’s prima facie conclusion that the claims are obvious over the combined cited prior art, and we affirm the Examiner’s rejection of the claims. CONCLUSION The rejection of claims 1–3, 5, and 7–10 as unpatentable under 35 U.S.C. § 103, is affirmed. 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). AFFIRMED Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 5, 7–10 103 Lasser 1–3, 5, 7–10