CTC BIO, INC.Download PDFPatent Trials and Appeals BoardSep 24, 20212021000406 (P.T.A.B. Sep. 24, 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. 15/738,194 12/20/2017 Hong Ryeol JEON 16477-000029-US-NP 1070 28997 7590 09/24/2021 Harness Dickey (St. Louis) 7700 Bonhomme, Suite 400 St. Louis, MO 63105 EXAMINER GREENE, IVAN A ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 09/24/2021 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): bkamer@hdp.com stldocket@hdp.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HONG RYEOL JEON, BONG-SANG LEE, HYUN-IL KIM, and HAN-SEUNG LEE Appeal 2021-000406 Application 15/738,194 Technology Center 1600 Before JOHN E. SCHNEIDER, DEBRA L. DENNETT, and RACHEL H. TOWNSEND Administrative Patent Judges. SCHNEIDER, 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, 3, 5–11, and 13. We have jurisdiction under 35 U.S.C. § 6(b). We Affirm. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as CTC Bio, Inc. Appeal Br. 3. Appeal 2021-000406 Application 15/738,194 2 CLAIMED SUBJECT MATTER The claims are directed to “a purgative composition for cleansing an intestinal tract with high quality of bowel cleansing and high drug compliance, and a method for cleansing an intestinal tract using the same.” Spec. ¶ 1. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A purgative composition comprising polyethylene glycol, sorbitol and sodium picosulfate, wherein the composition comprises 40 to 60g of polyethylene glycol, 10 to 28g of sorbitol, and 1 to 10mg of sodium picosulfate per 100ml of the com position in a liquid dosage form. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Aronson US 2006/0029570 A1 Feb. 9, 2006 Thomas2 WO 2009/036906 A1 Mar. 26, 2009 Skoog et al., Effects of osmotically active agent on colon transit, 18 Neurogastroenterol. Motil. 300 (2006) Haringsma and Mulder, Colon cleansing, in Procedures in Hepatogastroenterology, 2d ed. (Tygat and Mulder, eds., 1997) REJECTION The Examiner has rejected the pending claims under 35 U.S.C. § 103 as unpatentable over Aronson in view of Skoog, Thomas, and Haringsma. 2 The Examiner and Appellant both refer to this reference as Thomas. The first named inventor is Petersen-Brann. For consistency we shall also refer to this reference as Thomas. Citations are to the English machine translation of record. Appeal 2021-000406 Application 15/738,194 3 OPINION The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 1, 3, 5–11, and 13 would have been obvious to one of ordinary skill in the art at the time the invention was made over Aronson combined with Skoog, Thomas, and Haringsma. The Examiner finds Aronson teaches a therapeutic polyethylene glycol (“PEG”) solution concentrate for the treatment of constipation or gastrointestinal lavage. Final Act. 6. The Examiner finds Aronson teaches that the solution may comprise from about 0.1 to 0.8 g PEG per mL of solution which the Examiner finds equals 10 to 80 g PEG per 100 mL of solution. Id. The Examiner finds that Aronson teaches that the solution may comprise a stimulant laxative such as bisacodyl and a sweetener. Id. The Examiner finds that Aronson does not teach the use of sorbitol as a sweetener nor does it teach the use of sodium picosulfate. Id. at 7. The Examiner finds Skoog teaches that sorbitol can be used as a sweetener and as an osmotic laxative. Id. The Examiner finds Skoog teaches using sorbitol in amounts of 10 and 27 g results in accelerated colon transit. Id. at 7–8. The Examiner finds Thomas teaches compositions which combine osmotic laxatives such as PEG and sorbitol with stimulant laxatives such as bisacodyl and sodium picosulfate. Id. at 9. The Examiner finds Thomas teaches using from 1 to 20 mg or preferably 5 to 10 mg of the stimulant laxatives. Id. The Examiner finds Haringsma teaches colon cleansing using PEG containing compositions where part of the PEG is replaced with sorbitol to improve the taste of the composition. Id. at 9–10. Appeal 2021-000406 Application 15/738,194 4 The Examiner concludes It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a purgative liquid dosage form including from about 0.1 g to about 0.8 g PEG per mL of solution (i.e. 10- 80 g per 100 mL of solution), the PEG having an average molecular weight of 3350, and further including a sweetener and a stimulant laxative such as bisacodyl, as taught by ARONSON, and the sweetener/osmotic purgative being sorbitol at 10–27 g, as the sorbitol would have improved the palatability of the compositions without undesirable concomitant side effects (i.e. no significant effects on abdominal pain, nausea and bloating), as taught by SKOOG, and further to include the stimulant laxative bisacodyl or sodium picosulfate in a preferable amount of 1 to 20 mg, or a more preferable amount [of] 5 to 10 mg, as taught by THOMAS. Id. at 12–13. Appellant contends “None of the cited art teaches or suggests inclusion of PEG, sorbitol and sodium picosulfate or PEG, sorbitol and bisacodyl in the recited concentrations in a single formulation.” Appeal Br. 7. Appellant contends that the Examiner has not shown why one skilled in the art would combine the teachings of the references. Id. Appellant contends that one skilled in the art would not combine the teachings of the references as Aronson relates to overnight relief of constipation whereas Aronson and Skoog are for accelerated colonic cleansing. Id. at 7–8. Appellant also contends that the art teaches away from the present invention as it teaches that the use of sorbitol can have serious side effects. Id. at 9–10. We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Action and Answer regarding this rejection. We find the Examiner has established a prima facie showing that the subject matter of the claims would have been Appeal 2021-000406 Application 15/738,194 5 obvious over Aronson combined with Skoog, Thomas, and Haringsma to a person of ordinary skill in the art at the time the invention was made. Appellant has not produced evidence showing, or persuasively argued, that the Examiner’s determinations on obviousness are incorrect. Only those arguments made by Appellant in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2015). We have identified claim 1 as representative; therefore, all claims fall with claim 1. We address Appellant’s arguments below. Appellant argues that none of the references teach the use of the different ingredients recited in the claims in a single composition. Appeal Br. 7. Appellant argues that there is no guidance in the references to combine the references as suggested by the Examiner. Id. We are not persuaded by Appellant’s argument. Aronson teaches a PEG containing laxative composition having a PEG concentration overlapping with the concentrations recited in claim 1. Aronson ¶ 14. Aronson also teaches that that composition may contain a sweetener. Aronson ¶ 15. Finally, Aronson teaches that the composition may include a stimulant laxative such as bisacodyl. Id. 19. Thus Aronson teaches a laxative composition that comprises PEG, a sweetener and a stimulant laxative such as bisacodyl. Skoog teaches that sorbitol is a sweetener that can be used in a laxative compositions. Skoog, 300. Thomas and Haringsma both teach that sorbitol can be used as a laxative. Thomas, 1; Haringsma, 280. Given the teachings of the references, we find that one skilled in the art would have been guided to use sorbitol as the sweetener in the composition of Aronson. Appeal 2021-000406 Application 15/738,194 6 Thomas teaches that both bisacodyl and sodium picosulfate are stimulant laxatives and that they can be used in amounts that overlap with the ranges recited in claim 1. Thomas, 2. We find that it would have been obvious to one skilled in the art to substitute sodium picosulfate for bisacodyl taught in Aronson. It is obvious to those skilled in the art to substitute one known equivalent for another. See In re Omeprazole Patent Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another.”). Thus we agree with the Examiner that the guidance to combine the teachings of the references lies within the references themselves, particularly within Aronson. Ans. 6–7. Appellant contends that one skilled in the art would not have been motivated to combine the references as the compositions disclosed are intended for different applications. Appeal Br. 7. Appellant contends that Aronson is directed to overnight relief of constipation, whereas Skoog and Haringsma are directed to accelerated colonic treatment or for cleansing prior to a colonoscopy or surgery. Id. We have considered this argument and the teachings of the references and we are unpersuaded that the rejection is in error. While Aronson suggests that the disclosed composition may be used for overnight relief of constipation, Aronson also teaches “[t]he polyethylene glycol solution of the present invention may be used in much larger doses as a preparation for cleansing the bowel for diagnostic or operative purposes (e.g., as a gastrointestinal lavage preparation with or without supplemental electrolytes).” Aronson ¶ 39. Aronson also teaches PEG may be combined with bisacodyl to form a gastrointestinal preparation. Id. We agree with the Appeal 2021-000406 Application 15/738,194 7 Examiner that the references are not inconsistent and that it would have been obvious to modify Aronson to include the laxative agents taught by the other references. Ans. 4–6. Appellant contends that the art teaches away from the use of sorbitol in a laxative composition. Appeal Br. 9–10. Appellant cites to Shaver3 and Skoog for support of this proposition. Id. Appellant points to the discussion in Skoog concerning various adverse effects caused by sorbitol. Id. at 9. Appellant also points to the passage in Shaver that mentions that sorbitol led to serious side effects including death. Id. We have considered Appellant’s arguments and the references of record and are not persuaded that the art, as a whole, teaches away from the use of sorbitol. “A reference that teaches away is a significant factor to be considered in determining unobviousness, the nature of the teaching is highly relevant, and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). While Shaver discusses certain serious side effects that may result from the use of certain sugar alcohols and the consensus not to use such compounds in laxatives, the study referenced in Shaver was conducted in 1979. Shaver ¶ 11. Skoog, Thomas, and Haringsma, reporting work done almost twenty years later, and all teach the use of sorbitol in laxative compositions. Thus, at the time the present invention was made the art supported the use of sorbitol. 3 Shaver, WO2012/102799 A2, published Aug. 2, 2012. (“Shaver”) Appeal 2021-000406 Application 15/738,194 8 With respect to Skoog, while Skoog noted that the absence of significant side effects may have been due to a type II error, Skoog unequivocally states “a single dose of sorbitol (27 g) markedly accelerated colonic transit and increased flatulence, but not other gastrointestinal symptoms in healthy subjects.” Skoog, 305. Skoog also reports an earlier study that 10 g of sorbitol taken with a meal was well tolerated. Id. at 300. Based on the foregoing, we agree with the Examiner that the art, when viewed as a whole, does not teach away from the use of sorbitol in a laxative composition. We conclude that a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 1, 3, 5–11, and 13 would have been obvious to one of ordinary skill in the art at the time the invention was made over Aronson combined with Skoog, Thomas, and Haringsma. CONCLUSION The Examiner’s rejection is affirmed. More specifically, the rejection of claims 1, 3, 5–11, and 13 under 35 U.S.C. § 103 as unpatentable over Aronson in view of Skoog, Thomas, and Haringsma is affirmed DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3, 5–11, 13 103 Aronson, Skoog, Thomas, Haringsma 1, 3, 5–11, 13 Appeal 2021-000406 Application 15/738,194 9 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation