Ex Parte Bateman et al

Patent Trial and Appeal Board

Mar 4, 2019

13699497 (P.T.A.B. Mar. 4, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/699,497 01/18/2013 69921 7590 03/06/2019 WASHINGTON UNIVERSITY c/o POLSINELLI PC 100 SOUTH FOURTH STREET SUITE 1000 SAINT LOUIS, MO 63102-1825 FIRST NAMED INVENTOR Randall J. Bateman 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. 047563-449385 1042 EXAMINER BALLARD,KIMBERLY ART UNIT PAPER NUMBER 1649 NOTIFICATION DATE DELIVERY MODE 03/06/2019 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): USPT@POLSINELLI.COM PTOL-90A (Rev. 04/07) UNITED ST ATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RANDALL J. BATEMAN, DAVID M. HOLTZMAN, and KW ASI G. MAWUENYEGA Appeal2018-004556 Application 13/699,497 Technology Center 1600 Before JEFFREY N. FRED MAN, JOHN G. NEW, and JAMIE T. WISZ, Administrative Patent Judges. WISZ, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellants 1 seek review of the Examiner's rejections of claims 1-12, 20-22, and28-31. We have jurisdiction under 35 U.S. C. § 6(b ). For the reasons set forth below, we AFFIRM. BACKGROUND Appellants' disclosure relates to methods for determining AP metabolism in blood. Spec. ,r 3. Independent claims 1 and 20 are illustrative and are reproduced below: 1 Appellants identify the Real Party in Interest as Washington University. App. Br. 1. Appeal2018-004556 Application 13/699,497 Claim 1 : A method for measuring the in vivo turnover of AP in blood, the method comprising: (a) administering at least one labeled amino acid to a subject; (b) collecting at least one blood sample from the subject between about 15 minutes and about 4 hours after administration of the at least one labeled amino acid; ( c) detecting and measuring by mass spectrometry the amount of labeled AP, or the amount of both labeled AP and unlabeled AP, in at least one blood sample obtained from the subject between about 15 minutes and about 4 hours after administration of at least one labeled amino acid; and ( d) calculating the turnover of AP in blood using the amount of labeled AP, or the amount of both labeled AP and unlabeled AP, measured in step ( c ), wherein only those samples obtained between 15 minutes and 4 hours after administration of the at least one labeled amino acid to the subject are used in step (d). Claim 20: A method for measuring the in vivo turnover of AP in blood, the method comprising: (a) administering at least one labeled amino acid to a subject, wherein the label is administered in at least one bolus or as a 9 hour infusion; (b) collecting from the subject at least two blood samples between (i) about 1 and about 5 hours after bolus administration, or (ii) about 5 hours and about 10 hours after the 9-hour infusion has begun; ( c) detecting and measuring by mass spectrometry the amount of labeled AP, or the amount of both labeled AP and unlabeled AP, in each of the two or more blood samples obtained between about 1 and 5 hours after bolus administration and between about 5 and 10 hours after the 9 hour infusion has begun, and using only these measurements to calculate the peak time of labeled AP production for the subject, wherein labeled AP production peaks between about 1 and 5 hours after bolus 2 Appeal2018-004556 Application 13/699,497 administration and between about 5 and 10 hours after the 9- hour infusion has begun; and ( d) calculating the turnover of AP in blood from the peak of labeled AP determined by step ( c ). The claims stand rejected as follows: I. Claims 1-10, 20-22, and28-31 stand rejected under 35 U.S.C. § 102(b) as being anticipated by Bateman. 2 II. Claims 1-12, 20-22, and28-31 stand rejected under 35 U.S.C. § 102( e) as being anticipated by West. 3 III. Claims 1-12, 20-22, and28-31 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 7, 10, 12-20, and22 ofU.S. Patent No. 7,892,845 4 ("the '845 patent) in view of West. IV. Claims 1, 2, 4, 6-10, 20-22, 28, and 30 stand rejected, as a provisional rejection, on the ground of nonstatutory double patenting as being unpatentable over claims 1---6 and 10-17 of copending Application No. 15/057,694. ISSUES AND ANALYSIS We affrrm the Examiner's anticipation rejections. We also affrrm the obviousness-type double patenting rejection over the '84 5 patent in view of West. We do not address the provisional nonstatutory double patenting 2 Bateman et al., US 2008/0145941 Al, published June 19, 2008 ("Bateman''). 3 West et al., US 2012/0015371 Al, filed December 4, 2009 ("West"). 4 U.S. Patent No. 7,892,845 B2, issued February 22, 2011. 3 Appeal2018-004556 Application 13/699,497 rejection, which is moot. The arguments raised by Appellants are addressed below. I. Rejection of claims 1-10, 20-22, and28-31 under 35 U.S.C. § 102(b) as being anticipated by Bateman The Examiner finds that Bateman teaches: (a) administering a labeled amino acid to a subject (see [0030]); (b) obtaining a biological sample, such as blood or plasma ( see [0037]), from the subject; and ( c) detecting and measuring by mass spectrometry (MS) the labeled and unlabeled biomolecules in the sample (see, for example, [0029] and [0041]), so as to determine the in vivo metabolism of AP (i.e., calculate the turnover of AP) in blood (see [0024]). Non-Final Act. 3. The Examiner also fmds that Bateman discloses that one or more samples may be taken from the subject after administration of the labeled amino acid (Bateman ,r 39), and that such blood sample( s) may be taken hourly for 36 hours. (Bateman ,r 40 and Fig. 5). Non-Final Act. 3. Figure 5 of Bateman is reproduced below: 4 Appeal2018-004556 Application 13/699,497 YHiTn lTHnn,-, "l l f ! ! ·, 't"11 .:f:!x-,.fS~i~mpl;:::g : 1 ~ ! ; ; : ; : : ~; : ~ ~ : ; ~ ~ [ ; I : : ! j :....J..,) ... LJ .... LLJ .. L:.J .. l-J .... ../. ... J... ... t .. .J..,..,._ ... ~ ... .J,..........:: ' · • • t i . , i . , i r,rrrrr,rrrrrnT,THTlTn1 c::.:r.~iJ.-~:~·~;·•~f ~ .: ~ ; : ~ ~ : ~ : : : ~ : ~ J : : ~ ; : ~ ; :; ~ ~ :: : ; ~ : ; ~ : : ~ , -t-~-l't'~-j-t !--'-Ht-1-tt-~-t*'~-tt-r: ! ~ 1 ; ! : ~ I ! ~ I M ti ~ ~3 'i ~ ~{, :?.~ 4~~ iiS ;.<4 }~ ,~)~•·:c "FIG. 5 depicts a schematic illustrating the in vivo labeling protocol." Bateman ,r 13. Bateman also states that "biological samples obtained during the first 12 hours of sampling (i.e., 12 hrs afterthe start of the labeling) may be used to determine the rate of synthesis of the protein .... " Bateman ,r 40. Claim 1 As the Examiner points out, all that is required in step (b) of claim 1 is the collection of at least one blood sample from the subject between about 15 minutes and about 4 hours after administration of the labeled amino acid. Ans. 5. We agree with the Examiner that Bateman teaches hourly sample collection up to 36 hours, which provides for the collection of at least one 5 Appeal2018-004556 Application 13/699,497 blood sample within the claimed time window. 5 Id. Step ( c) of claim 1 recites measuring the amount of labeled AP or labeled and unlabeled AP in the sample and step ( d) recites calculating the tumover6 of AP in blood using only the sample( s) obtained between 15 minutes and 4 hours after administration of the labeled amino acid. Bateman also teaches that, in calculating the synthesis or clearance rate of the protein, "a minimum of one sample is typically required ( one could estimate the baseline label), two are preferred, and multiple samples are more preferred .... " (Bateman ,r,r 45, 46). Since Bateman includes embodiments in which samples are taken within the 15 minute to 4-hour timeframe and includes embodiments in which only one or two samples are taken, Bateman necessarily includes embodiments in which a single sample or only two samples are taken during the claimed time range. These one or two samples are then used to calculate the turnover rate, as recited in steps ( c) and ( d) of claim 1. Appellants argue that the "genus" collection timeframe of blood samples as disclosed in Bateman does not anticipate the "species" collection timeframe of about 15 minutes to about4 hours as recited in claim 1. App. 5 We note that there is a disagreement between the Appellants and the Examiner regarding the correct claim construction for the term "after administration" and whether it refers to after the infusion has begun or after the infusion has been completed. Since Bateman teaches the collection of hourly samples for 36 hours, it discloses collection of samples within the claimed 15 minute to 4-hour timeframe regardless of which claim construction is used. Therefore, we do not address the claim construction issue here. 6 '" [T]umover'" is defmed in the Specification as "the rate of labeled AP production, the rate oflabeled AP clearance, or a combination of both." Spec. if 9. 6 Appeal2018-004556 Application 13/699,497 Br. 3--4. We are not persuaded. The instant situation is similar to that in Wrigley, where the Court found that: This is not a case in which the prior art reference merely discloses a genus and the clann at issue recites a species of that genus .... Shahidi specifically discloses WS-23 as a coolant and menthol as a flavoring agent. The question for purposes of anticipation is therefore whether the number of categories and components in Shahidi was so large that the combination of WS-23 and menthol would not be immediately apparent to one of ordn1arv skill in the art See Perricone v. Medicis Pharm . ., Corp., 432 F.3d 1368, 1377 (Fed.Cir.2005) (distinguishing cases in which a prior art reference discloses a genus from those in which it discloses a nun1ber of species as part of a list). Wm. Wrigley Jr. Co. v. Cadbury Adams USALLC, 683 F.3d 1356, 1361 (Fed. Cir. 2012). In the instant case, we find that Bateman specifically discloses taking samples during the claimed 15 minute to four-hour timeframe. See, e.g., Fig. 5 of Bateman. Bateman also discloses that only one or two samples may be taken for purposes of calculating turnover (Bateman ,r,r 45, 46). Therefore, Bateman discloses taking and measuring one or two samples during the claimed timeframe. Appellants also contend that Bateman does not teach that samples collected prior to 4 hours after administration of the labeled amino acid may be used to determine AP turnover in blood as required in steps ( c) and ( d) of claim 1. App. Br. 5-7. We are not persuaded. Appellants have not adduced any evidence of record that suggests that an ordinary artisan would have considered Bateman's disclosure of sample collection and turnover calculation to be non-enabling. [D ]uring patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art 7 Appeal2018-004556 Application 13/699,497 reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement. In re Antor Media Corp., 689 F.3d 1282, 1289 (Fed. Cir. 2012). Furthermore, Bateman explicitly discloses taking and measuring samples from the claimed timeframe. (Bateman Fig. 5 and ,r,r 40, 45, 46). Claim 20 The analysis for claim 20 is similar as to that of claim 1. Claim 20 recites collecting from a subject at least two blood samples between (i) about 1 and 5 hours after bolus administration, or (ii) about 5 hours and about 10 hours after a 9-hour infusion has begun. The Examiner finds that "Bateman teaches both intravenous infusion over 9 hours as well as bolus administration in a single dose (see [0033])." Non-Final Act. 4. Appellants' arguments are similar to those made for claim 1 and primarily focus on the assertion that the "narrow range of collecting two or more blood samples obtained between about 1 and 5 hours after bolus administration and between about 5 and 10 hours after a 9 hour infusion has begun is never explicitly disclosed or implied by Bateman." App. Br. 7-8. Appellants also argue that Bateman never mentions calculating the peak time of labeled AP production using these timeframes. Id. at 8. As discussed above, Bateman discloses obtaining samples on an hourly basis (Bateman ,r 40) and Figure 5 shows the collection ofblood samples during the recited timeframes of claim 20. In addition, Bateman teaches a preferred embodiment of collecting two samples (Bateman ,r,r 45, 46). Therefore, Bateman discloses embodiments that would include collecting and analyzing at least two samples within the claimed time ranges of claim 20. 8 Appeal2018-004556 Application 13/699,497 Having considered Appellants' arguments in support of claims 1 and 20, we are not persuaded of any reversible error in the Examiner's rejection of these claims. For the reasons described herein and those already of record, we sustain the Examiner's rejection of claims 1 and 20 as being anticipated by Bateman. Claims 2-10, 21, 22, and 28-31 are not argued separately, and fall with claims 1 and 20. See 37 C.F.R. § 4I.37(c)(l)(iv). II. Rejection of claims 1-12, 20-22, and28-31 under 35 U.S.C. § 102( e) as being anticipated by West The Examiner also fmds that the claims are anticipated by West. The analysis of this rejection is similar to the analysis under Bateman because the relevant disclosures of West and Bateman are consistent. App. Br. 9. As with the Bateman rejection, the Appellants' main argument is that West fails to disclose the narrow blood collection timeframes of claims 1 and 20. App. Br. 9-10. However, the Examiner fmds that West discloses the collection of a blood sample from a subject hourly from Oto 12 hours, 0 to 24 hours, or O to 36 hours (West ,r 46), thereby meeting the limitations of step (b) of claim 1. Ans. 10. West also discloses that, in one embodiment, "the sample is obtained from the subject at a single predetermined time point, for example within an hour of labeling." West ,r 46. Therefore, West discloses the use of only this one sample for calculating the turnover of AP in blood, as recited in steps ( c) and ( d) of claim 1. Furthermore, as with Bateman, West also teaches that, in calculating the synthesis or clearance rate of the protein, "a minimum of one sample is typically required ( one could estimate the baseline label), two are preferred, and multiple samples are more preferred .... " (West,r,r 62, 63). Therefore, for the same reasons discussed for Bateman, West discloses embodiments 9 Appeal2018-004556 Application 13/699,497 that would include collecting and analyzing one or two samples within the claimed time ranges of claim 20. For the reasons described herein and those already of record, we sustain the Examiner's rejection of claims 1 and 20 as being anticipated by West. Claims 2-12, 21, 22, and 28-31 are not argued separately, and fall with claims 1 and 20. See 37 C.F.R. § 41.37( c )(1 )(iv). III. Rejection of claims 1-12, 20-22, and28-31 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 7, 10, 12-20, and22 of the '845 patent7 in view of West The Examiner fmds that the claims are unpatentable over claims 1, 3, 6, 7, 10, 12-20, and22 of the '845 patent in view of West. Claim 1 of the '845 patent recites a method for measuring the in vivo metabolism of a protein synthesized in the central nervous system by administering and measuring a labeled moiety. Appellants argue that the use of a blood sample, and the critical timeframes for calculating in vivo turnover in the sample, are not found in the reference claims of the '84 5 patent and that West does not remedy these deficiencies. App. Br. 11-16. The Examiner agrees that the claims of the '845 patent recite the collection of cerebrospinal fluid (CSF), as opposed to blood; however, the Examiner fmds that this teaching is supplied by West which discloses that blood may be used in a method to calculate the metabolism of Ap. Ans. 13. The Examiner further fmds that West teaches 7 The '845 patent is the patent that issued from the Bateman application (US 2008/0145941) discussed herein. 10 Appeal2018-004556 Application 13/699,497 that these biological fluids are functional equivalents, and therefore the substitution of blood for CSF would have been obvious. Id. With regard to calculating in vivo turnover, Appellants argue that the critical collection timeframe is not taught in the '845 patent because the specification of the '845 patent indicates that, when the CSF samples were tested in Example 2, " [ t] here was no measurable labeled AP for the first 4 hours followed by an increase from 5 to 13 hours." App. Br. 13. Appellants argue that this portion of the '845 specification establishes that when the method of the reference claims is used to measure in vivo metabolism of AP in CSF, samples should be obtained greater than 4 hours after the start of the administration of the labeled moiety. App. Br. 12-14. Appellants further argue that West does not remedy these deficiencies because it does not contribute any new information to the labeling and sample collection protocols disclosed in the '845 patent. App. Br. 14--15. We are not persuaded by the Appellants' arguments. As discussed above, claim 1 only requires collection of at least one blood sample within the timeframe of about 15 minutes to about 4 hours after administration of the labeled amino acid. We agree with the Examiner that it would have been obvious to substitute the CSF sample with a blood sample as taught in West. We also agree with the Examiner that West teaches that a blood sample may be obtained from a subject on an hourly basis and, in one embodiment, teaches that a single sample can be obtained an hour after labeling. (West ,r 46). This disclosure meets the limitations of steps ( c) and ( d) of claim 1 as discussed supra with regard to the West anticipation rejection. Therefore, one of skill in the art would have been motivated to use the method 11 Appeal2018-004556 Application 13/699,497 described in the reference claims of the '845 patent with blood samples taken during the claimed timeframes based on the disclosure in West. With regard to claim 20, we note that the collection timeframes recited in the claim include times that are more than 4 hours after administration of the labeled amino acid. Therefore, Appellants' argument that the '845 patent in view of West would notteach collection ofa sample less than 4 hours after administration does not seem to apply to this claim. As discussed above for the anticipation rejection, West discloses embodiments that would include collecting and analyzing samples within the claimed time ranges of claim 20. In addition, West teaches that the skilled person can adjust the amount of samples and timeframes accordingly, in stating: As will be appreciated by those of skill in the art, the number of samples and when the samples are taken generally will depend upon a number of factors such as: the type of analysis, type of administration, the protein of interest, the rate of metabolism, the type of detection, and the type of subject. West,r 45. We find that it would have been obvious to optimize the timeframe for collecting samples and the number of samples tested to determine the peak time of labeled AP in the blood within the ranges disclosed by West. See In re Aller, 220 F.2d454, 456 (CCPA 1955) ("[W]herethe 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."). Therefore, we affirm the Examiner's rejections of claims 1 and 20 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 7, 10, 12-20, and22 of the '845 patent in view of West. Claims 2-12, 21, 22, 12 Appeal2018-004556 Application 13/699,497 and 28-31 are not argued separately, and fall with claims 1 and 20. See 37 C.F.R. § 4I.37(c)(l)(iv). IV. Provisional rejection of claims 1, 2, 4, 6-10, 20-22, 28, and 30 on the ground of nonstatutory double patenting as being unpatentable over claims 1---6 and 10-17 of copending Application No. 15/057,694 Application No. 15/057 ,694 was abandoned on March 3, 2018; therefore, this rejection is moot. CONCLUSION I. We affrrm the Examiner's rejection of claims 1-10, 20-22, and 28-31 as being anticipated by Bateman. II. We affrrm the Examiner's rejection of claims 1-12, 20-22, and 28-31 as being anticipated by West. III. We affrrm the Examiner's rejection of claims 1-12, 20-22, and 28-31 for non-statutory double patenting over claims of the '845 patent and West. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 13