Ex Parte KulmannDownload PDFBoard of Patent Appeals and InterferencesDec 18, 201010380405 (B.P.A.I. Dec. 18, 2010) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte HERMANN KULMANN __________ Appeal 2010-008897 Application 10/380,405 Technology Center 1600 __________ Before TONI R. SCHEINER, ERIC GRIMES, and LORA M. GREEN, Administrative Patent Judges. GREEN, Administrative Patent Judge. DECISION ON APPEAL1 This is a decision on appeal under 35 U.S.C. § 134 from the Examiner’s rejection of claims 2-20 and 22-41. We have jurisdiction under 35 U.S.C. § 6(b). 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-008897 Application 10/380,405 2 STATEMENT OF THE CASE Claims 38 and 39 are representative of the claims on appeal, and read as follows: 38. A method for hormonal contraception comprising administering at least one contraceptive hormone in a plurality of linked taking periods optionally having a sequence lasting several years, wherein each of said taking periods comprises: at least one taking cycle, wherein each taking cycle comprises -a duration-constant taking phase lasting several days and -a taking pause lasting several days, wherein in each taking phase said hormonal component is administrated in a daily unit, and in each taking pause either a placebo free from any hormone component is administered or no unit is administered, wherein the duration of the taking phase or phases of at least the final taking period is at least 22 days, and wherein the duration of each taking phase in any taking period preceding a following taking period is shorter than that in each of the taking phases in each following taking period. 39. An administration form useful for hormonal contraception, according to a method for hormonal contraception which comprises administering at least one contraceptive hormone in a plurality of linked taking periods optionally having a sequence lasting several years, wherein each of said taking periods comprises: at least one taking cycle, wherein each taking cycle comprises -a duration-constant taking phase lasting several days and -a taking pause lasting several days, said form comprising a plurality of packaging units, each of which comprises at least one set of daily units to be administered within each of said taking cycles and wherein the duration of said taking phases is constant, said taking period in each case comprising a number of daily hormone units corresponding to the duration of each taking phase, as well as optionally a number of daily placebo units corresponding to the duration of each taking pause, the duration of the taking phase or phases of at least the last of the taking periods following the first taking period being at least 22 days, and wherein the number of daily hormone units in any packaging unit corresponding to a taking period preceding a following taking period is Appeal 2010-008897 Application 10/380,405 3 smaller than in the packaging unit corresponding to the in each case following taking period. The following grounds of rejection are before us for review: I. Claim 19 stands rejected under 35 U.S.C. § 112, second paragraph, as being indefinite. II. Claims 2-19, 22-36, and 38-41 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Spona2 and Hodgen.3 III. Claims 20 and 37 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Spona and Hodgen as further combined with Endrikat.4 We summarily affirm rejection I, but reverse rejections II and III. ISSUE (Indefiniteness) The Examiner’s statement of the rejection may be found at page 3 of the Answer. As Appellant does not argue the merits of the rejection, we summarily affirm the rejection of claim 19 under 35 U.S.C. § 112, second paragraph, as being indefinite. 2 Spona, US 5,583,129, December 10, 1996. 3 Hodgen, EP 0,911,029 A2, April 28, 1999. 4 J. Endrikat et al., A Twelve-Month Comparative Clinical Investigation of Two Low- Dose Oral Contraceptives Containing 20µg Ethinylestradiol/75 µg Gestodene and 30 ug Ethinylestradiol / 75 µg Gestodene, with Respect to Efficacy, Cycle Control, and Tolerance,55 CONTRACEPTION 131-137 (1997). Appeal 2010-008897 Application 10/380,405 4 ISSUE (Obviousness) Has the Examiner established by a preponderance of the evidence that the combination of Spona and Hodgen renders obvious a method of contraception wherein the duration of each taking phase in any taking period preceding a following taking period is shorter than that in each of the taking phases in each following taking period? FINDINGS OF FACT FF1 The Examiner initially notes: The instant claims are construed as follow[s]: the herein claimed contraceptive method and composition comprises a treatment plan with different taking periods. Within the treatment duration, the taking phase in the final taking period is always longer than that in any other taking periods. In addition to taking phase, taking period also contains taking pause, which usually happened after taking phase. (Ans. 3.) FF2 The Examiner’s statement of the rejections may be found at pages 4-6 of the Answer. FF3 Specifically, the Examiner relies on Spona for teaching a method of contraception comprising administering a hormonal agent, such as ethinylestradiol and drospirenone, for 23 to 24 days, followed by 5 or 4 pill- free days, with an administration cycle of 28 days. (Ans. 4.) FF4 The Examiner notes that Spona “does not expressly teach [that] the last taking phase is longer than any preceding phase,” and also “does not expressly teach the taking period lasts at least 40, 50, 60, 70, 80, 90, 100, 110, . . . [to a] maximum of 150 days.” (Id.) Appeal 2010-008897 Application 10/380,405 5 FF5 The Examiner relies on Hodgen for teaching “the benefit of prolonged administration of the hormonal components for contraception as better control of endometrial bleeding and may help the breakthrough bleeding.” (Id.) FF6 Specifically, Hodgen teaches: [A] women [sic] in need of contraception is administered a combined dosage form of estrogen and progestin, preferably monophasicly, for 60 to 110 consecutive days, preferably about 80-90 days, followed by an administration free interval of 3 to 10 days, preferably about 5-8 days, in which the daily amounts of estrogen and progestin are equivalent to about 5-35 mcg of ethinyl estradiol and about 0.025 to 10 mg of norethindrone acetate, respectively. On a schedule of 84 days administration followed by 7 pill free days, there are only four treatment and menstrual cycles per year. (Hodgen ¶20.) FF7 In the Example provided by Hodgen, female monkeys were placed on ultra low dose oral contraceptive for either 60 consecutive days, followed by 3 non-treatment days, or for 84 consecutive days, followed by 7 non- treatment days. (Id. at ¶28.) The regimens were continued throughout the treatment cycle. (Id.) FF8 The Examiner concludes “[i]t would have been obvious to one of ordinary skill in the art . . . to adjust[ ] the taking phase to the herein recited duration.” (Ans. 5.) FF9 Specifically, according to the Examiner, “[i]t would be a routine procedure to titrate the dosage for patients that starting the lower dosage or regular 28-day dosage (i.e., 21-day regimen with 7-day placebo) and then Appeal 2010-008897 Application 10/380,405 6 gradually prolong the dosage to 23-day, 24-day, then 60-day, and up to 110- day regimen as taught [by Hodgen].” (Id. at 6.) FF10 As to the rejection of claims 20 and 37 as being rendered obvious by the combination of Spona and Hodgen as further combined with Endrikat, the Examiner relies on Endrikat to meet the limitation of reducing the dosage of the hormone in successive taking phases. (Id.) PRINCIPLES OF LAW While the analysis under 35 U.S.C. § 103 allows flexibility in determining whether a claimed invention would have been obvious, KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), it still requires showing that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. “We must still be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008). ANALYSIS Appellant argues that the Examiner has not provided a reason as to why the teachings of Spona or Hodgen, individually or in combination, Appeal 2010-008897 Application 10/380,405 7 would teach or suggest to the ordinary artisan successively extending the taking periods. (App. Br. 3-4.5) We agree. Although the taking periods of Hodgen are longer than those of Spona, both of Spona and Hodgen teach taking periods of constant duration. (See, e,g,, FFs 3 and 6.) The Examiner has not provided scientific reasoning or evidence to support the conclusion that it would have been obvious to increase the length of each successive taking period as required by the independent claims on appeal. CONCLUSION OF LAW We conclude that the Examiner has not established by a preponderance of the evidence that the combination of Spona and Hodgen renders obvious a method of contraception wherein the duration of each taking phase in any taking period preceding a following taking period is shorter than that in each of the taking phases in each following taking period. We are thus compelled to reverse the rejection of claims 2-19, 22-36, and 38-41 under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Spona and Hodgen. Moreover, as the Examiner does not cite Endikrat to remedy the deficiencies of the combination of Spona and Hodgen, we are also compelled to reverse the rejection of claims 20 and 37 5 As the pages of the Appeal Brief are not numbered, we designate the page titled “Response to Notification of Non-Compliant Appeal Brief” as page 1, and number the pages consecutively from there. Appeal 2010-008897 Application 10/380,405 8 under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Spona and Hodgen as further combined with Endrikat. 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). AFFIRMED-IN-PART dm MILLEN, WHITE, ZELANO & BRANIGAN, P.C. 2200 CLARENDON BLVD. SUITE 1400 ARLINGTON VA 22201 Copy with citationCopy as parenthetical citation