Ex Parte Schenk et alDownload PDFPatent Trials and Appeals BoardMay 30, 201910522320 - (D) (P.T.A.B. May. 30, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 10/522,320 10/17/2005 88484 7590 06/03/2019 CR MILES P.C. 405 Mason Court, Suite 119 Fort Collins, CO 80524 FIRST NAMED INVENTOR John L. Schenk 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. XY-16 Optimum US 6962 EXAMINER GOUGH, TIFFANY MAUREEN ART UNIT PAPER NUMBER 1651 NOTIFICATION DATE DELIVERY MODE 06/03/2019 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): crmiles@crmiles.com patents@stgen.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN L. SCHENK and ALLISON C. LINDSEY1 Appeal2018-005519 Application 10/522,320 Technology Center 1651 Before ERIC B. GRIMES, MICHAEL J. FIZTPATRICK, and TIMOTHY G. MAJORS, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of separating sperm based on whether they contain an X or a Y chromosome, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm-in-part. STATEMENT OF THE CASE "Effective preselection of sex has been accomplished in many species of livestock." Spec. 1: 11. However, "[a] significant problem with sperm 1 Appellants identify the Real Party in Interest as XY, LLC. Appeal Br. 3. Appeal2018-005519 Application 10/522,320 cells that have been separated into subpopulations based upon a specific sperm cell characteristic can be lower motility, lower viability or lower fertility." Id. at 1 :26-28. The Specification states that conventional procedures of handling and transporting semen prior to separation of sperm cells into subpopulations is typically carried out at about 5°C, or at a temperature at which sperm cell membrane lipids have transitioned from a liquid phase to a gel phase. The transition of sperm cell membranes lipids from the liquid phase to the gel phase can alter the chemical, physical, physiological, or functional attributes of sperm cells which can result in lower fertility of such sperm cells or can result in sperm cell death. Id. at 1 :28-34. The Specification discloses "methods in which sperm cells are incubated at temperatures above which sperm cell membrane lipids transition from a liquid phase to a gel phase." Id. at 3:24--26. Claims 1, 5, 6, 8-12, 15, 16, 18, 21, 150, 151, and 154--159 are on appeal. Claim 1 is illustrative and reads as follows: 1. A method of separating sperm cells, comprising: obtaining sperm cells of a species of mammal; cooling said sperm cells to a temperature in the range of about 7° C to about 17° C prior to staining said sperm cells; staining said sperm cells with Hoechst 33342 stain at a temperature between 30° C to 39° C; determining a sex characteristic of a plurality of said sperm cells; separating said plurality of sperm cells based upon said sex characteristic into an X chromosome bearing population and a Y chromosome bearing population; and collecting at least one of said X chromosome bearing population and said Y chromosome bearing population. 2 Appeal2018-005519 Application 10/522,320 The claims stand rejected as follows: Claims 1, 5, 6, 10, 12, 15, 16, 18, 21, 156, 157, and 159 under 35 U.S.C. § I03(a) as obvious based on Schenk2 (Ans. 3) and Claims 1, 5, 6, 8-12, 15, 16, 18, 21, 150, 151, and 154--159 under 35 U.S.C. § I03(a) as obvious based on Buchanan, 3 Squires,4 Schenk, Tardif, 5 Ellington, 6 Padilla,7 and Johnson8 (Ans. 5). I The Examiner rejects claims 1, 5, 6, 10, 12, 15, 16, 18, 21, 156, 157, and 159 as obvious based on Schenk. The Examiner finds that Schenk teaches "a method of separating sperm cells comprising obtaining a semen sample ... , cooling the semen sample [to about 5° CJ ... , determining a characteristic of the sperm cells, such as a sex characteristic ... , staining with Hoechst 33342 at 34°C ... , separating and collecting the sperm cells." Ans. 4. 2 Schenk, WO 01/37655 Al, published May 31, 2001. 3 Buchanan et al., Insemination of Mares with low numbers of either unsexed or sexed spermatozoa, 53 Theriogenology 1333-1344 (2000). 4 Squires, WO 00/06193, published Feb. 10, 2000. 5 Tardif et al., Use of Hoechst 33342 Stain to Evaluate Live Fresh and Frozen Bull Sperm by Computer-Assisted Analysis, 19(2) J. Andrology 201- 206 (1998). 6 Ellington et al., US 6,140,121, issued Oct. 31, 2000. 7 Padilla et al., Extender and Centrifugation Effects on the Motility Patterns of Slow-Cooled Stallion Spermatozoa, 69 J. Animal Sci. 3308-3313 (1991). 8 Johnson, Sex Preselection by Flow Cytometric Separation of X and Y Chromosome-bearing Sperm Based on DNA Difference: a Review, 7 Reprod. Fertil. Dev. 893-903 (1995). 3 Appeal2018-005519 Application 10/522,320 The Examiner concludes that it would have been obvious to cool sperm cells to within the temperature range recited in the claims because Schenk teaches temperatures including, for example, 5° C and "[t]he claims are drawn to 'about' ranges which allows for degrees slightly above and below the 'about 7' degree and therefore the ranges overlap or are merely close and thus a prima facie case of obviousness exists." Id. We agree with the Examiner that Schenk supports a prima facie case of obviousness. Schenk discloses "a method of cryopreserving sperm that have been selected for a specific characteristic ... such as sex-type." Schenk 2: 20-21, 29. Schenk's method involves, among other steps, "obtaining a selected sperm sample" and "cooling the selected sperm sample." Id. at 4:30-31. Preferably, "the selected sperm sample is cooled typically from about 22°Celsius, to about 5°Celsius." Id. at 10:20-21. Schenk exemplifies a method in which "[ s ]perm from 4 bulls were diluted" and "then cooled to 5°C at 0.2°C/min over 90 minutes .... All samples were incubated at 5°C for 24 or 48 h post-collection." Id. at 17: 17, 26-28. Sperm samples prepared in this way (id. at 21 :3--4) were diluted and "Hoechst 33342 dye was added .... [S]amples were incubated 60 minutes at 34°C." Id. at 21:12-15. The stained sperm samples "were sorted for sex-type at a 90% purity level. Sorted sperm were collected." Id. at 35:6-11. Schenk thus expressly discloses all of the limitations of claim 1, except for cooling sperm cells to a temperature between about 7° C and about 17° C before staining. However, Schenk discloses cooling sperm cells to a temperature of "about 5°Celsius" (id. at 10:21) and we agree with the 4 Appeal2018-005519 Application 10/522,320 Examiner that Schenk's "about 5°Celsius" overlaps or abuts the lower end ("about 7° C") recited in claim 1. The Specification does not expressly define how much variation is encompassed by "about," as recited in claim 7. However, the Schenk Declaration9 states that "the term 'about' as it relates [to] the temperature at which sperm cells are incubated prior to staining means ± 1 °C." Schenk Deel. ,r 14. The Schenk Declaration does not address how a person of ordinary skill in the art would interpret "about 5°Celsius," as disclosed by the Schenk reference. In particular, the Schenk Declaration does not provide any reason for concluding that a skilled artisan would interpret "about" in one way with respect to the claims and in another way with respect to Schenk's disclosure. We therefore conclude that the same language should be interpreted the same way in both contexts. Thus, Schenk's "about 5°Celsius" is reasonably interpreted to encompass a range of 4 ° C to 6° C, and claim 1 's "about 7° C" is reasonably interpreted to encompass a range of 6° C to 8° C. Based on this interpretation, both ranges include a temperature of 6° C. The range disclosed by Schenk therefore renders obvious the range recited in claim 1. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) ("A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art."); In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (claimed range of 50-100 A overlaps prior art range of 100-600 A). In addition, even if Schenk's "about 9 Declaration under 37 C.F.R. § 1.132 of John L. Schenk, filed Sept. 26, 2016. 5 Appeal2018-005519 Application 10/522,320 5°Celsius" were interpreted not to overlap the claimed range, we note that Schenk also expressly suggests that "[ d]uring the isolation step, the cooled sperm should generally be kept cold, i.e., between about 1 and about 8°Celsius, and preferably close to 4 or 5°Celsius." Schenk 11 :5-7. Schenk therefore suggests a temperature range (about 1-8° Celsius) that overlaps the range recited in claim 1. Appellants argue that Schenk's Examples 2 and 3 did not include determining a sex characteristic or separating and collecting X chromosome- bearing and Y chromosome-bearing populations. Appeal Br. 11. While this is true, the Examiner also relies on Schenk's Example 6 (Ans. 4), which does include sorting sperm by sex-type (Schenk 35:8-11). Appellants also argue that, in view of the Specification, a skilled artisan would not interpret "about 7° C," as recited in claim 1, to encompass 5° C. Appeal Br. 13. Appellants argue that "Claim 1 includes a range of temperature of 'about 7° C to about 17° C' which a person of ordinary skill in the art in view of reading the description would understand avoids the conventional procedures of handling and transporting semen prior to separation of sperm cells of 5° C" and "[i]f ... the claimed temperature of about 7° C encompasses 5° C, it would render Appellant's teaching to avoid the conventional procedures of handling and transporting semen prior to separation of sperm cells at 5° C meaningless." Id. Appellants also argue that "Claim 5 ... divides the temperature range of Claim 1 into increments of about 1 ° C .... If, as the Examiner asserts, 'about' encompasses a two-degree difference, there would be no meaningful difference between the 'about' 1 ° C incremental differences set out in Claim 6 Appeal2018-005519 Application 10/522,320 5." Id. at 14. Appellants conclude that "[a]ccordingly, the term 'about', when considered in the context of the term as it is used in the specification and claims of the application means at most +/- 1 ° C." Id. This argument is also unpersuasive. The issue is not, as Appellants frame it, whether claim 1 's "about 7° C" encompasses 5° C, but whether the claimed range-which includes "about 7° C"----overlaps the prior art range of "about 5°Celsius." That is, both the claimed range and the prior art range include values outside the expressly stated endpoint, because both 7° C and 5° Care modified by "about," and the issue is whether the variability of the ranges is sufficient for the two ranges to overlap. For the reasons discussed above, we conclude that the two ranges are reasonably interpreted to overlap, and therefore that Schenk renders the method of claim 1 prima facie obvious. Appellants argue that claim 5 "includes the element of 'incubating said sperm cells prior to staining at a temperature above which sperm cell membrane lipids transition from a liquid phase to gel phase"' and Schenk "does not teach, suggest or even contemplate incubation temperatures in relation to lipid transition temperature." Appeal Br. 15. This argument is unpersuasive because claim 5 expressly recites a temperature of "about 7° C" and, for the reasons discussed above, "about 7° C" is reasonably interpreted to overlap Schenk's "about 5°Celsius." Appellants also argue that they have presented evidence of unexpected results for the claimed method. Appeal Br. 20. Appellants point to results shown in the Specification that are said to show that the claimed method results in sex-sorted sperm having "greater motility and progressive 7 Appeal2018-005519 Application 10/522,320 motility, greater fertility, and lesser percentage dead than sperm cells of conventional separation methods incubated outside the range of about 7° C to about 17° C." Id. at 22, quoting Schenk Deel. ,r 26. See also Appeal Br. 22-24, Schenk Deel. ,r,r 27-29. We are not persuaded that Appellants' evidence demonstrates that the claimed method would not have been obvious. "One way for a patent applicant to rebut a prima facie case of obviousness is to make a showing of 'unexpected results."' In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). However, "[e]vidence of unexpected results must be reasonably commensurate with the scope of the claims." In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011). "If an applicant demonstrates that an embodiment has an unexpected result and provides an adequate basis to support the conclusion that other embodiments falling within the claim will behave in the same manner, this will generally establish that the evidence is commensurate with [the] scope of the claims." Id. Here, the Schenk Declaration points to the results shown in the Specification regarding motility and progressive motility, percentage of dead sperm cells, and the number of mares becoming pregnant after insemination with sorted sperm. Schenk Deel. ,r,r 27-29. We agree that the cited experiments show significantly better results for sperm cooled to 15° C than for sperm cooled to 5° C. See Spec. Figs. 8 and 11, Table 1. However, no results for pregnancy rates are disclosed for any temperature in the claimed range other than 15° C. Spec. 6-7. With respect to motility, the Specification states that "storing, handling, transferring, or transportation at about l 5°C can maintain highest 8 Appeal2018-005519 Application 10/522,320 levels of total or progressive motility of sperm cells or stimulated sperm cells." Id. at 18:14--16 (discussing Fig. 8). With respect to sperm survival, the Specification states that "% dead of sperm cells after staining as described above can be reduced by storing or transporting sperm cells at 15°C." Id. at 19:17-18 (discussing Fig. 11). Figures 8 and 11 also show motility and percentage of dead sperm cells at 10° C; however, the Specification does not state that the results seen at 10° Care significantly better than those seen at 5° C. See Spec. 18-19. The Specification states that Figure 9 shows that "the temperature at which sperm cells are transferred, stored, or handled prior to a staining protocol ... can be adjusted to increase total or progressive motility of sperm cells" and that "storage, transfer, or transport temperatures of between about 5°C to about 20°C can increase total and progressive motility of sperm cells." Id. at 18. Again, however, the Specification does not describe the results seen at 10° C as significantly different from those seen at 5° C. 10 Thus, while the Specification demonstrates that cooling to 15° C provides a significant improvement over the conventional process of cooling to 5° C, no such improvement has been shown for temperatures in the claimed range below 15° C. In particular, and as the Examiner has pointed out (Ans. 14), Appellants have not provided evidence that cooling to "about 10 The Specification does state that "embodiments of the invention used to process stimulated equine sperm cells comprise temperatures between about 10°C to about l 5°C for handling, storing, or transferring of stimulated equine sperm cells." Id. at 18. This statement, however, refers to sperm cells stimulated with caffeine, which is not required by the claims on appeal. 9 Appeal2018-005519 Application 10/522,320 7° C," as claimed, provides unexpectedly superior results compared to the prior art process of cooling to 5° C. Thus, Appellants' evidence of unexpected results is not commensurate with the scope of the claims and therefore does not demonstrate nonobviousness for the claimed process as a whole. Claims 5, 6, 10, 12, 15, 16, 18, 21, 156, 157, and 159 fall with claim 1 because they were not argued separately. 37 C.F.R. § 4I.37(c)(l)(iv). II The Examiner rejects all of the claims on appeal as obvious based on Buchanan, Squires, Schenk, Tardif, Ellington, Padilla, and Johnson. For the reasons discussed above, we conclude that Schenk's disclosure by itself would have made obvious the method of claim 1. We therefore affirm the rejection of claim 1 under 35 U.S.C. § 103(a) based on Schenk combined with Buchanan, Squires, Tardif, Ellington, Padilla, and Johnson. This is not a new ground of rejection. See In re Kronig, 539 F.2d 1300, 1302 (CCP A 1976) ("[T]he ultimate criterion of whether a rejection is considered 'new' in a decision by the board is whether appellants have had fair opportunity to react to the thrust of the rejection."). With respect to claims 1, 5, and 157, Appellants rely on the same arguments that were presented with respect to the rejection based on Schenk alone. Appeal Br. 17-19. These arguments are not persuasive for the reasons discussed above. With regard to claims 8 and 9, Appellants argue that "Claim 8 includes the feature 'a bovine species ... at about 17° C' and Claim 9 includes the feature of 'an equine species ... at about 15° C['] which 10 Appeal2018-005519 Application 10/522,320 incubation temperatures prior to staining are not taught or suggested by the combination." Appeal Br. 18-19. We agree with Appellants that the Examiner has not shown that cooling a sperm cell sample to about 15° C or about 17° C would have been obvious based on the cited references. The Examiner states that "the art teaches temperatures overlapping with or merely close to the claimed range for cooling before staining, i.e. at 5 and l 5°C." Ans. 6. However, the Examiner has not identified any disclosure of cooling to 15° C in any of the cited references, see id. at 5---6, and no such teaching is apparent to us. The Examiner also reasons that "adjusting cooling temperature ... [is] a mere optimization of a result effective variable." Id. at 8. The Examiner finds that Schenk "teaches between 5°C to 22°C." Id. We do not agree with the Examiner's reasoning or fact-finding on this point. First, Schenk discloses that a "sperm sample is cooled typically from about 22 °Celsius to about 5°Celsius." Schenk 10:20-21 ( emphasis added). Thus, Schenk describes a process in which a sperm sample starts out at 22° Candis cooled to 5° C. This disclosure does not teach cooling to a temperature in the range of 5° C to 22° C, as the Examiner implies. Second, while "the discovery of an optimum value of a variable in a known process is normally obvious," an exception to that rule is where "the parameter optimized was not recognized to be a result-effective variable." In re Antonie, 559 F .2d 618, 620 (CCP A 1977). Here, the Examiner has not identified any teaching in the cited references that would have led a skilled artisan to expect that the results obtained for a sex-selected sperm sample would be affected in any way by adjusting the temperature to which it is 11 Appeal2018-005519 Application 10/522,320 cooled before staining. The Examiner thus has not shown that the temperatures recited in claims 8 and 9 would have been obvious to achieve through routine optimization. We affirm the rejection of claims 1, 5, and 157 under 35 U.S.C. § 103(a) based on Buchanan, Squires, Schenk, Tardif, Ellington, Padilla, and Johnson. Claims 6, 10-12, 15, 16, 18, 21, 150, 151, 154--156, 158, and 159 fall with claim 1 because they were not argued separately. 37 C.F.R. § 4I.37(c)(l)(iv). However, we reverse the rejection as applied to claims 8 and 9. SUMMARY We affirm the rejection of claims 1, 5, 6, 10, 12, 15, 16, 18, 21, 156, 157, and 159 under 35 U.S.C. § 103(a) as obvious based on Schenk. We affirm the rejection of claims 1, 5, 6, 10, 12, 15, 16, 18, 21, 156, 157, and 159 under 35 U.S.C. § 103(a) based on Buchanan, Squires, Schenk, Tardif, Ellington, Padilla, and Johnson. We reverse the rejection of claims 8 and 9 under 35 U.S.C. § 103(a) based on Buchanan, Squires, Schenk, Tardif, Ellington, Padilla, and Johnson. 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 12 Copy with citationCopy as parenthetical citation