Ex Parte Matthiesen

Patent Trials and Appeals BoardMar 21, 2019

14348134 - (D) (P.T.A.B. Mar. 21, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/348,134 03/28/2014 22878 7590 Agilent Technologies, Inc. Global IP Operations 5301 Stevens Creek Blvd Santa Clara, CA 95051 03/25/2019 FIRST NAMED INVENTOR Steen Hauge Matthiesen 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. 09138.0155-00000 2010 EXAMINER CROW, ROBERT THOMAS ART UNIT PAPER NUMBER 1634 NOTIFICATION DATE DELIVERY MODE 03/25/2019 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): IPOPS.LEGAL@agilent.com Agilentdocketing@cpaglobal.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEEN HAUGE MATTHIESEN 1 Appeal2018-005964 Application 14/348, 134 Technology Center 1600 Before ULRIKE W. JENKS, JOHN E. SCHNEIDER, and RYAN H. FLAX, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal2 under 35 U.S.C. Â§ 134 from the Examiner's rejection of claims to method for hybridizing nucleic acid sequences, which have been rejected for failure to comply with the written description 1 Appellant identifies the Real Party in Interest as Dako Denmark A/S. Appeal Br. 2. 2 We have considered and herein refer to the Specification of Mar. 28, 2014 ("Spec."); Final Office Action of July 3, 2017 ("Final Act."); Advisory Action of Oct. 4, 2017 ("Adv. Act."); Appeal Brief of Dec. 15, 2017 ("Appeal Br."); Examiner's Answer of Feb. 1, 2018 ("Ans."); and Reply Brief of Apr. 2, 2018 ("Reply Br."). Appeal2018-005964 Application 14/348, 134 requirement, as indefinite, and for non-statutory obviousness-type double patenting. We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM. STATEMENT OF THE CASE In hybridization, known segments of nucleic acids and probes or primers are used to bind or hybridize to a target nucleic acid. Spec. 1. The Specification describes a hybridization technique that "provides several potential advantages over prior art hybridization applications, such as faster hybridization times, higher denaturation temperatures, lower hybridization temperatures, and less toxic hybridization solvents." Spec. 4. Claims 27, 28, 31-36, 38,-50, 52-55, and 60-68 3 are on appeal. Claim 27 is representative and reads as follows: 27. A method of hybridizing nucleic acid sequences compnsmg: - providing a first nucleic add sequence, - providing a second nucleic acid sequence, - providing a hybridization composition comprising formamide, and - combining the first and the second nucleic acid sequence and the hybridization composition for at least a time period sufficient to hybridize the first and second nucleic acid sequences, wherein the time period is less than 4 hours, and wherein the hybridization is before a stringent wash, wherein the concentration of formamide is 10% to 25% v/vÂ· ' 3 Claim 68 was added to the application in an Amendment After Final filed Sept. 5, 2017. The Examiner rejected claim 68 as indefinite and for non- statutory obviousness-type double patenting in an Advisory Action mailed Oct. 4, 2017. 2 Appeal2018-005964 Application 14/348, 134 wherein the hybridization composition further comprises 15% to 80% w/v of an accelerating agent and 400 mM to 1200 mM of a salt. The claims stand rejected as follows: Claims 27, 28, 31-36, 38-50, 52-55, and 60-67 have been rejected under 35 U.S.C. Â§ 112, first paragraph, for failure to comply with the written description requirement. Claim 68 has been rejected under 35 U.S.C. Â§ 112, second paragraph, as indefinite. 4 Claims 27, 28, 31-36, 38-50, 52-55, and 60-68 have been rejected for non-statutory obviousness type double patenting over claims 1---6 and 18-54 ofMatthiesen5 as evidenced by Schubart6 and Belogi. 7 WRITTEN DESCRIPTION Issue The issue with respect to this rejection is whether the Examiner properly determined that the amended claims contain new matter not described in the Specification as filed. In response to a rejection for indefiniteness, Appellant amended the then pending claims to recite that the percentage of accelerating agent present in the recited composition is on a weight per volume (wt/v) basis. 4 Claims 27, 28, 31-36, 38-50, 52-55, and 60-67 were also rejected under 35 U.S.C. Â§ 112, second paragraph, as indefinite. Final Act. 4. This rejection was withdrawn by the Examiner. Ans. 8. 5 Matthiesen, US 9,303,287 B2, issued Apr. 5, 2016 ("Matthiesen"). 6 Schubart, US 5,919,894, issued July 6, 1999 ("Schubart"). 7 Belogi et al., US 2008/0076923 Al, published Mar. 27, 2008 ("Belogi"). 3 Appeal2018-005964 Application 14/348, 134 Amendment filed Jan. 26, 2016 ("Amend. I"). Appellant argued that the amendment was supported by the Specification, incorporated the teachings of Poulsen, 8 and that Poulsen taught the use of dextran sulfate on a wt/v basis. Amend. I, 7-8. Subsequently, Appellant amended the Specification to specifically recite the disclosure of Poulsen previously incorporated by reference, namely, that dextran sulfate was present in a wt/v basis. Amendment filed June 8, 2017 ("Amend. II"). The Examiner maintained the rejection for written description finding that the Specification did not contain a teaching that the accelerating agent was used on a wt/v basis. Final Act. 3. The Examiner maintains that the amendment to the claims reciting the percentage of accelerating agent in terms of wt/v represent new matter. Id. Principles of Law A description adequate to satisfy 35 U.S.C. Â§ 112, first paragraph, must "clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed." In other words, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) ( en bane) ( citation omitted, alteration in original). [T]he test requires an objective inquiry into the four comers of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must 8 Poulsen et al., US 2005/0266459 Al, published Dec. 1, 2005 ("Poulsen"). 4 Appeal2018-005964 Application 14/348, 134 describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed. Id. Analysis We agree with Appellant that the Specification provides adequate written support of the percentage of accelerating agent being based on wt/v. The Specification as filed incorporates by reference the teachings of Poulsen which states that dextran sulfate is used on a wt/v basis in hybridization. Spec. 24; Poulsen ,r 40. Incorporation by reference can be used to satisfy the written requirement. 37 C.F.R. Â§ 1.57(c)(l). Appellant has also amended the Specification to specifically recite the same disclosure found in Poulsen regarding the use of dextran sulfate. Amend II, 2 and 8. Thus, the Specification, as amended, now includes an express discussion of an accelerating agent being used on a wt/v basis. Finally, Appellant has offered evidence in the form of a Declaration of Dr. Matthiesen,9 the inventor, who states that one skilled in the art, reading the present Specification, would understand that the accelerating agent is used on a wt/v basis. Appeal Br. 6-7; Matthiesen Deel. ,r,r 3-5. Dr. Matthiesen states that the Specification teaches that dextran sulfate is used as a solid and that when solids are incorporated into a solution, one skilled in the art would understand that the percentage recited refers to a wt/v basis. Id. 9 Declaration of Steen H. Matthiesen Under 37 C.F.R. Â§ 1.132, filed June 8, 2017 ("Matthiesen Deel."). 5 Appeal2018-005964 Application 14/348, 134 We find that Appellant has persuasively demonstrated that when read in context, the Specification supports the conclusion that accelerating agents are used on a wt/v basis. The Examiner contends that the teaching that dextran sulfate may be used on a wt/v basis does not support a finding that any accelerating agent can be used on a wt/v basis. Ans. 9-10. The Examiner contends that accelerating agents can be either a solid or a liquid and that dextran sulfate in not representative of the entire class of agents. Id. The Examiner also finds Dr. Matthiesen's Declaration unpersuasive in that it does not present evidence as to whether the present Specification meant to say wt/v. Id. at 10. The Examiner also points to several references where the use of dextran sulfate is taught on a volume/volume basis. Id. at 11-13. The Examiner contends that given the fact that the art routinely used both wt/v and v/v, one skilled in the art would not conclude that the instant Specification refers to wt/v. Id. at 13. We have considered the Examiner's arguments and are not persuaded. As discussed above, the incorporation by reference of Poulsen adds the teachings of using dextran sulfate on a wt/v basis. Thus, the Specification describes using an accelerating agent on a wt/v basis. In addition, we find that Appellant has presented evidence that one skilled in the art, reading the Specification, would understand that the accelerating agent would be used on a wt/v basis. Dr. Matthiesen has not only expressed his opinion on this point, but also given a factual basis for the opinion. Matthiesen Deel. ,r,r 3- 5. Other than the statement that the Examiner does not consider the 6 Appeal2018-005964 Application 14/348, 134 Declaration to provide evidence, the Examiner has failed to adequately explain why the Examiner doubts Dr. Matthiesen's testimony. While we agree with the Examiner that the art appears to use both wt/v and v/v, we do not find that this supports the conclusion that one skilled in the art would not understand which basis was meant in the present Specification. Again, the reference incorporated by reference clearly teaches the use of an accelerating agent on a wt/v basis. We agree with Appellant that one skilled in the art reading the entire disclosure in context would understand that the accelerating agent is to be used on wt/v basis. Conclusion of Law We conclude that use of accelerating agents on a weight by volume basis is adequately described in the Specification and the amendment to the claims to add that limitation does not constitute new matter. INDEFINITENESS Issue The issue with respect to this rejection is whether the Examiner has properly concluded that the lack of a basis for the percentage of the accelerating agent in claim 68 renders the claim indefinite Claim 68 recites the limitation "wherein the hybridization composition further comprises 15% to 80% of an accelerating agent." Appeal Br. 17-18 (Claims App'x). The Examiner finds that the failure to recite the basis for the percentage of the accelerating agent renders the claim indefinite. Ans. 7. 7 Appeal2018-005964 Application 14/348, 134 Appellant contends that a person of ordinary skill in the art would understand from reading the Specification that the accelerating agent is used on a wt/v basis and that the claim refers to that basis. Appeal Br. 9--10. Principles of Law "The standard of indefiniteness is somewhat high; a claim is not indefinite merely because its scope is not ascertainable from the face of the claims." Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1342 (Fed. Cir. 2003). Rather, "[a] claim is indefinite if, when read in light of the specification, it does not reasonably apprise those skilled in the art of the scope of the invention." Id. Analysis We agree with Appellant that claim 68 is not indefinite. As discussed above, the Specification teaches that at least one accelerating agent is used on a wt/v basis. In addition, Appellant has presented persuasive evidence that one skilled in the art would interpret the teachings of the Specification as calling for the use of an accelerating agent on a wt/v basis. Based on the foregoing, we conclude that one skilled in the art would interpret claim 68 as calling for a percentage of an accelerating agent on a wt/v basis. Conclusion of Law We conclude that the Examiner has not established that claim 68 is indefinite. 8 Appeal2018-005964 Application 14/348, 134 OBVIOUSNESS-TYPE DOUBLE PA TENTING Issue The issue with respect to this rejection is whether the Examiner has shown that the claims of the present application are not patentably distinct from claims 1---6 and 18-54 of Matthiesen as evidenced by Schubart and Belogi. Claim 1 of Matthiesen reads: 1. A composition comprising at least one polar aprotic solvent in an amount effective to enable hybridization of a nucleic acid sequence to an RNA sequence within a cell in a sample having a preserved cell morphology, and at least 10% dextran sulfate, wherein the polar aprotic solvent is not dimethyl sulfoxide (DMSO). The Examiner finds that pending claims are not patentably distinct from those of Matthiesen "because both sets of claims contain the same limitations ( e.g., reaction times, salts, accelerating agents, concentrations and temperatures, and formamide )." Final Act. 6. The Examiner finds that the additional elements recited in the present claims would have been discovered through routine experimentation and, absent evidence of unexpected results, would have been obvious. Id. at 7. Appellant contends that the present claims are patentably distinct in that the claims of Matthiesen do not recite a hybridization composition that contains formamide in the claimed concentration. Appeal Br. 10. Appellant points to claims 7-10 of Matthiesen as teaching that either formamide is not to be used or to be used at concentration less than the concentration recited in the present claims. Id. Appellant also argues that the fact that the claims 9 Appeal2018-005964 Application 14/348, 134 of Matthiesen may dominate the present claims is not sufficient to establish double patenting. Principles of Law Obviousness-type double patenting entails a two-step analysis. First, the allegedly conflicting claims are construed and, second, the difference(s) between the claims are considered to determine whether the claims are patentably distinct. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001 ). "A later patent claim is not patentably distinct from an earlier patent claim if the later claim is obvious over, or anticipated by, the earlier claim." Id. "[T]he analysis in the Pfizer decision shows that obviousness-type double patenting encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound." Sun Pharm. Industries Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1386 (Fed. Cir. 2010) (citing Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir. 2008)). Analysis We find that the Examiner's finding of obviousness-type double patenting is correct. Claim 1 of Matthiesen claims a composition that contains a polar aprotic solvent and at least 10% dextran sulfate. Matthiesen col. 50, 11. 56-61. While Matthiesen does not list a specific amount of solvent, the claim refers to an amount effective to enable hybridization. Id. Matthiesen teaches that the amounts of polar aprotic solvent can range from 1 % to 95% (v/v) with concentrations of 1 % to 5%, 5% to 10%, 10%, 10% to 10 Appeal2018-005964 Application 14/348, 134 20%, 20% to 30%, 30% to 40%, 40% to 50%, or 50 to 60 % being suitable. Matthiesen col. 3, 1. 64- col. 4, 1. 5. Schubart and Belogi teach that fonnamide is a polar aprotic solvent. Schubart col. 5, 11. 10-20; Belogi ,r 38. The compounds recited in claim 1 of Matthiesen overlap with the compounds used in the claimed method. In addition, claim 1 specifically refers to the use of the compound to hybridize a nucleic acid sequence to an RNA sequence. Matthiesen col. 50, 11. 5 6-57. Thus, the claim itself suggests the method recited in the present claims. As such, the present method claims are not patentably distinct from the product claims of Matthiesen. Appellant's arguments with respect to formamide are not persuasive. While we agree that claims 7-10 either teach against using formamide or using a lower amount, as shown above, the teachings of claim 1 embrace the claimed method including the use of formamide in the claimed amounts. Moreover, as the Examiner has pointed out, the rejection is not based on claims 7-10. Ans. 15. Conclusion We conclude that the Examiner correctly determined that claim 2 7 is not patentably distinct from claims 1---6 and 18-54 of Matthiesen as evidenced by Schubart and Belogi. Claims 28, 31-36, 38-50, 52-55, and 60---68 have not been argued separately and therefore fall with claim 27. 37 C.F.R. Â§ 4I.37(c)(l)(iv). 11 Appeal2018-005964 Application 14/348, 134 SUMMARY We reverse the rejection under 35 U.S.C. Â§ 112, first paragraph. We reverse the rejection under 35 U.S.C. Â§ 112, second paragraph. We affirm the rejection for non-statutory obviousness-type double patenting. 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