12462606 (P.T.A.B. Mar. 22, 2016)

Ex Parte Dougherty et al

Patent Trial and Appeal BoardMar 22, 2016

12462606 (P.T.A.B. Mar. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/462,606 08/06/2009 49003 7590 03/22/2016 MICHAEL L. DUNN SIMPSON & SIMPSON, PLLC 5555 MAIN STREET WILLIAMSVILLE, NY 14221 FIRST NAMED INVENTOR Thomas J. Dougherty 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 ATTORNEY DOCKET NO. CONFIRMATION NO. RPP197US 1935 EXAMINER ANDERSON, JAMES D ART UNIT PAPER NUMBER 1629 MAILDATE DELIVERY MODE 03/22/2016 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte THOMAS J. DOUGHERTY, RA VIND RAK. PANDEY, and WILLIAM R. POTTER Appeal2013-004928 Application 12/462,606 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, and JEFFREY N. FREDMAN, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL 1 This appeal under 35 U.S.C. Â§ 134(a) involves claims 1-5 (App. Br. 5). Examiner entered rejections under 35 U.S.C. Â§ 103(a). We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM. 1 Appellants identify the Real Party in Interest as Health Research, Inc. (App. Br. 3). Appeal2013-004928 Application 12/462,606 STATEMENT OF THE CASE Appellants' claim 1 is representative and reproduced below: 1. A method for treatment of cancerous tissue in the upper respiratory system comprising the steps of: injecting HPPH2 in a physiologically compatible medium into a patient having the cancerous tissue at a level of 3 through 5 mg/m2 of body surface area, waiting for a time period of 24 through 60 hours to permit preferential absorption of the HPPH into the cancerous tissue, and exposing the cancerous tissue to light at a wavelength of about 665 Â± 5 nm at an energy of about 75 to about 200 Joules/cm. Claims 1-5 stand rejected under 35 U.S.C. Â§ 103(a) as unpatentable over the combination ofBellnier,3 Dougherty '216,4 and Dougherty '214.5 Claims 1-5 stand rejected under 35 U.S.C. Â§ 103(a) as unpatentable over the combination of Dougherty 20006 and Bellnier. 2 "HPPH, as used herein, means 2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a as a free acid, the acid salt form as well as the various esters" (Spec. i-f 14). 3 David A. Bellnier et al., Population Pharmacokinetics of the Photodynamic Therapy Agent 2-[l-Hexyloxyethyl]-2-devinyl Pyropheophorbide-a in Cancer Patients, 63 Cancer Research 1806-1813 (2003). 4 Dougherty et al., WO 2008/085216 Al, published July 17, 2008. 5 Dougherty et al., WO 2008/085214 A2, published July 17, 2008. 6 Thomas J. Dougherty et al., Preliminary clinical data on a new photodynamic therapy photosensitizer, 2-[l-hexyloxyethyl]-2- devinylpyropheophorbide-a (HPPH) for treatment of obstructive esophageal cancer, 3909 Proceedings of SPIE 25-27 (2000). 2 Appeal2013-004928 Application 12/462,606 FACTUAL FINDINGS (FF) FF 1. Dougherty '6527 discloses: that in humans many cancers and other hyperproliferative tissues can be effectively treated by injection of HPPH at the equivalent to a dose of0.05 to 0.11 mg/kg of body weight 24 hours post injection and exposed to 665 Â± 10 nm of light at a total delivered light dose of 50 to 200 joules/cm2. The lower limit is preferably 100 Joules/cm2 and the upper limit is preferably 150 Joules/cm2. (Dougherty '652 i-f 6; Ans. 15-16.) FF 2. Dougherty '4358 discloses: The method of the invention includes the steps of: injecting HPPH in a physiologically compatible medium into a patient having high grade esophageal dysplasia to provide a dose level of 3 through 5 mg/m2 of body surface area, waiting for a time period of 24 through 60 hours to permit preferential absorption of the HPPH into the high grade dysplasia tissue, and exposing the esophageal high grade dysplasia tissue to light at a wavelength of about 670 Â± 5 nm at an energy of from about 75 to about 200 Joules/cm. (Dougherty '435 i-f 11; Ans. 18.) FF 3. Appellants define the term "'upper respiratory system' as ... the nasal cavity, sinuses, oral cavity, pharynx, larynx, trachea, vocal cord and associated structures" (Spec. i-f 10). FF 4. Examiner finds that Appellants' use of the phrase "cancerous tissue in the upper respiratory system" reads on "the treatment of esophageal cancer" (Ans. 4; see App. Br. 15 ("Examiner has accepted that esophageal cancer is to be considered as 'upper respiratory cancer"')). 7 Dougherty et al., US 60/967,652, filed Sept. 6, 2007. 8 Dougherty et al., US 60/879,435, filed Jan. 9, 2007. 3 Appeal2013-004928 Application 12/462,606 FF 5. Bellnier discloses the investigation of"HPPH in a number of dose- ranging studies in ... patients with basal cell carcinoma(s), obstructive esophageal cancer, Barrett's esophagus with high-grade dysplasia, or early- or late-stage lung cancer" (Bellnier 1806; Ans. 5). FF 6. Bellnier discloses an injectable HPPH drug "formulated in 5% dextrose in sterile water containing 2% ethanol and 1 % polyoxyethylene sorbitan monooleate (Tween 80)," wherein doses of 3---6 mg/m2 "were administered i.v." (Bellnier 1807; Ans. 5 and 11). FF 7. Examiner finds that Bellnier discloses "treating cancerous tissue of the upper respiratory system," by disclosing "that 9 of the treated patients had esophageal carcinoma" (Ans. 5; see Bellnier 1806). FF 8. Bellnier discloses that "a 3 mg/m2 HPPH dose is ineffective, [in treating high-grade dysplasia in Barrett's esophagus,] whereas higher doses of 4, 5, or 6 mg/m2 may be capable of destroying both the dysplasia and most of the Barrett's esophagus when treated with 150 J/cm 665 nm light 48 h after injection" (Bellnier 1809; Ans. 5 and 11-12; see also Bellnier 1808 ("patients with partially obstructive esophageal cancer received a starting dose of 6 mg/m2 HPPH and a light dose of 150 J/cm ... delivered endoscopically 48 h after injection"); Bellnier 1809 ("three patients have been treated for lung cancer with HPPH ( 4 mg/m2), with two complete responses and one recurrence 1 month after treatment"). Examiner finds that a person of ordinary skill "reading Bellnier ... would .. . appreciate that varying the dose of HPPH will have an effect on the clinical efficacy of HPPH in photodynamic treatment of cancer" (Ans. 6). 4 Appeal2013-004928 Application 12/462,606 FF 9. Dougherty '216 discloses [a] method for treating cancer and other hyperproliferative tissues in humans that can be exposed to light comprising injection of HPPH at the equivalent to a dose of 0.05 to 0.11 mg/kg of body weight 24 hours post injection and exposing the tumor or other hyperproliferative tissue to 665 Â± 10 nm of light at 50 to 200 Joules/cm2 (Dougherty '216, Abstract; Ans. 6.) FF 10. Dougherty '216 discloses relief in breathing by treatment of the Bronchus with HPPH at a dose of "O .1 mg/kg with exposure of 100 to 140 Joules per cm of diffusion fiber at 665Â±5 nm Light Energy 48 HRS Post Injection" (Dougherty '216 i-f 16). FF 11. Dougherty '214 discloses [a] method for treatment of esophageal high grade dysplasia comprising the steps of: injecting HPPH in a physiologically compatible medium into a patient having high grade dysplasia tissue to provide a dose level of 3 through 5 mg/m2 of body surface area, waiting for a time period of 24 through 60 hours to permit preferential absorption of the HPPH into esophageal cancer tissue, and exposing the esophageal cancer tissue to light at a wavelength of about 670Â±5 nm at an energy of from about 75 to about 200 Joules/cm. (Dougherty '214, Abstract; id. i-f 13; Ans. 6-7.) FF 12. Examiner finds that Dougherty 2000 discloses, inter alia, exposing an obstructive esophageal cancer lesion "to 150 Joules/cm fiber for 6 minutes, 15 seconds at a wavelength of 665 nm" "approximately 48 hours after injection of 6 mg/m[2] HPPH" (Ans. 10-11, citing Dougherty 2000 26). FF 13. Examiner finds that Dougherty 2000 differs from Appellants' claimed invention by failing to disclose "a dose range of 3 through 5 mg/m2 ofHPPH" (Ans. 11). 5 Appeal2013-004928 Application 12/462,606 Priority: ISSUE Was priority to Dougherty '652, Dougherty '435, and Dougherty '4 7 49 properly denied? ANALYSIS Dougherty '652: Examiner denied Appellants' claim of priority to Dougherty '652 (see generally Ans. 2-5 and 8; Ans. 15-18 and 20; App. Br. 16 (Appellants explain that PCT/US07/20818 filed September 27, 2007 and Dougherty '652 have identical disclosures)). We recognize Appellants' reference to Marieb, 10 to support the contention that "[ m ]ucous membranes, or mucosae [] line body cavities that open to the exterior, such as those of the hollow organs of the digestive, respiratory, and urogenital tracts" (App. Br. 15-16; see generally Reply Br. 4--5; see FF 4--5; Ans. 17 ("Examiner[] acknowledges that [Appellants'] claims encompass treatment of esophageal cancer")). Examiner, however, finds that Appellants "failed to provide any logical rationale to support their position that disclosure of a dose of 0.05 to 0.11 mg/kg provides support for the presently claimed 3 through 5 mg/m2 or disclosure of 24 hours post injection provides support for the presently claimed 24 through 60 hour post injection" period (Ans. 16; see App. Br. 13 ("[a]ll that is missing from [Dougherty '652's disclosure] is the small 4-5 mg/m2 dosage range of claim 1 ")). Therefore, we find no error in 9 Dougherty et al., US 60/879,474, filed Jan. 9, 2007. 10 Elaine N. Marieb, Human Anatomy and Physiology 137 (Addison Wesley Longman Publishing, 5th ed. 2001 ). 6 Appeal2013-004928 Application 12/462,606 Examiner's conclusion that Dougherty '652 "fails to provide written support under 35 U.S.C. [Â§] 112, 1st paragraph for the limitations of the instant claims" (Ans. 18). Dougherty '435: Examiner denied Appellants' claim of priority to Dougherty '435 (see generally Ans. 5---6 and 9; Ans. 18-20; App. Br. 17 (Appellants explain that PCT/US2007/20816 filed September 27, 2007 and Dougherty '435 have identical disclosures)). Examiner finds that Dougherty '4 3 5 's disclosure of "high grade esophageal dysplasia" fails to provide written descriptive "support for the genus of 'cancerous tissue in the upper respiratory system' as [Appellants now] claim[]" (Ans. 18; see id. at 19 ("the specific and limited disclosure of 'high grade esophageal dysplasia' does not, either explicitly or implicitly, provide support for the treatment of 'cancerous tissue in the upper respiratory system"'); FF 2). In this regard, Examiner finds that "[t]he disclosure of a species, high grade esophageal dysplasia, does not provide written support for the genus 'cancerous tissue in the upper respiratory system"' and Appellants fail to provide "objective evidence" to support a contrary conclusion (Ans. 19). We agree. We recognize, but are not persuaded by Appellants' contention that a "specie can support the genus, as here where the tissues are essentially the same" (App. Br. 17). Stated differently, Appellants contend that Dougherty '435 provides written descriptive support for the claimed genus, because the specie high grade esophageal dysplasia makes obvious and, therefore, 7 Appeal2013-004928 Application 12/462,606 provides written descriptive support for the genus of cancerous tissue in the upper respiratory system. We are not persuaded. [W]hile the description requirement does not demand any particular form of disclosure, Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541F.3d1115, 1122 (Fed. Cir. 2008), or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement, Lockwood v. Am. Airlines, 107 F.3d 1565, 1571-72 (Fed. Cir. 1997). Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010)( en bane). Dougherty '474: Examiner denied Appellants' claim of priority to Dougherty '4 7 4 (see generally Ans. 2-9; Ans. 18; App. Br. 19 (Appellants explain that PCT/US2007/20818 filed September 27, 2007 and Dougherty '474 have the same disclosure)). Appellants withdrew their claim of priority to Dougherty '474 (Reply Br. 3). CONCLUSION OF LAW Priority to Dougherty '652, Dougherty '435, and Dougherty '474 was properly denied. Obviousness: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? 8 Appeal2013-004928 Application 12/462,606 ANALYSIS Based on Bellnier in combination with (a) Dougherty '216 and Dougherty '214 or (b) Dougherty 2000, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious to combine the teachings of the references so as to administer HPPH in the dose range instantly claimed, waiting a time period of from 24 to 60 hours, and exposing cancerous tissue in the upper respiratory system to light at a wavelength of about 665 +/- 5 nm at an energy of about 75 to about 200 Joules/cm for the treatment of cancerous tissue in the upper respiratory system of a patient. (Ans. 8 and 13.) In this regard, Examiner finds that a person of ordinary skill in this art would have "expect[ ed] that the dose of HPPH would need to be optimized for the treatment of a particular cancer type. Such optimization of dose ranges within the dose ranges disclosed in the prior art is not an act of invention" (Ans. 8-9 and 14, citing In re Aller, 220 F.2d 454, 456 (CCPA 1955)). The combination of Bellnier, Dougherty '216, and Dougherty '214: We recognize, but are not persuaded by, Appellants' contention that "[t]he dose level suggested by Bellnier [] for treatment of esophageal cancer is significantly greater than [Appellants] claim[]," which fails to take Dougherty '214 and Dougherty '216, or Examiner's rationale regarding the optimization of a dose range to treat a desired cancer, into consideration (App. Br. 19 and 21; Reply Br. 6; cf FF 10-13; see Ans. 21-23). For the foregoing reason we are not persuaded by Appellants' contention that, absent hindsight, Bellnier's disclosure of a "lower dose treatment for basal cell carcinoma ... do[ es] not extrapolate to upper respiratory cancers," 9 Appeal2013-004928 Application 12/462,606 because "[t]he skin has different tumor types than the upper respiratory system, different drug absorption rates, different drug elimination rates and different drug quantity acceptance, thus, in the absence of [Appellants'] claims and specification, causing completely unpredictable results" (App. Br. 19 and 21; Reply Br. 7). For the same reasons, we are not persuaded by Appellants' contention that Bellnier' s disclosure regarding lung cancer, fails to suggest Appellants' claimed invention, because "[l]ung tumors are clearly unique from those in the upper respiratory system, and [] the lung has different tumor types than the upper respiratory system, different drug absorption rates, different drug elimination rates and different drug quantity acceptance, thus causing completely unpredictable results" (id. at 19-20 and 21). We recognize, but are not persuaded by, Appellants' contention that Examiner's reliance on Dougherty '214's disclosure of the "treatment of esophageal high grade dysplasia" fails to make up for the foregoing deficiencies in Bellnier because, according to Appellants, Examiner's position with regard to the obviousness rejection is in conflict with Examiner's position regarding priority (App. Br. 20; see Ans. 21-22). There is no conflict because descriptive support may not rely on elements that are only obvious over the priority document, but a rejection under 35 U.S.C. Â§ 103 is based on obviousness. Cf Ariad, 598 F.3d at 1352; KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398 (2007). We recognize, but are not persuaded by, Appellants' contention that Dougherty '216 fails to make up for the foregoing deficiencies in Bellnier because it discloses cancers unrelated to those required by Appellants' claimed invention (App. Br. 20). Notwithstanding Appellants' contention to 10 Appeal2013-004928 Application 12/462,606 the contrary, Examiner explains that "[t]he combined teachings of the cited prior art teach that HPPH is effective over a broad range of doses for treating different cancers when administered prior to light at wavelengths having energies falling within the scope presently claimed" (Ans. 23). Stated differently, at the time of Appellants' claimed invention, a person of ordinary skill in this art would have appreciated the need to utilize routine optimization to adapt the method suggested by the combination of Bellnier, Dougherty '214, and Dougherty '216 to a particular cancer with a reasonable expectation of success (see Ans. 8-9 and 22-23, citing Aller, 220 F.2d at 456). The combination of Dougherty 2000 and Bellnier: We recognize, but are not persuaded by, Appellants' contention that Bellnier' s disclosure that 3 mg/m2 "is ineffective, [because] Bellnier [] clearly discourages investigation at doses lower than 6 mg/m2" (Reply Br. 6). Notwithstanding Appellants' contention to the contrary, Examiner explains that Bellnier suggests that dosages of "4, 5, or 6 mg/m2 may be capable of destroying both the dysplasia and most of the Barrett's esophagus when treated with 150 J/cm2 665 nm light 48 hours after injection" and the use of "4 mg/m2 HPPH ... in the treatment of lung cancer" (Ans. 23-24; FF 8). We recognize, but are not persuaded by, Appellants' contention that Dougherty 2000' s disclosure of "high dose treatment of esophageal cancer [] does not suggest low dose treatment of esophageal cancer or other upper respiratory cancers and thus cannot cure the critical defects of Bellnier [] and vice versa," which fails to account for the combination of Dougherty 2000 11 Appeal2013-004928 Application 12/462,606 with Bellnier or Examiner's rationale regarding the optimization of a dose range to treat a desired cancer (App. Br. 21; Reply Br. 7; cf Ans. 24--25; see also Ans. 14). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claim 1 under 35 U.S.C. Â§ 103(a) as unpatentable over the combination ofBellnier, Dougherty '216, and Dougherty '214 is affirmed. Claims 2-5 are not separately argued and fall with claim 1. The rejection of claim 1 under 35 U.S.C. Â§ 103(a) as unpatentable over the combination of Dougherty 2000 and Bellnier is affirmed. Claims 2-5 are not separately argued and fall with claim 1. 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. Â§ 1.136(a). AFFIRMED 12