DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Double Patenting
2. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
3. Claims 22-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,640,811 in view of Booth et al. (US 2014/0178881 A1).
Claims 1-17 of U.S. Patent No. 10,640,811 teach all the steps and elements as recited in instant claims 22-38, except the feature of measuring 5-hydroxy-methylcytosine (i.e., the method disclosed in claims 1-17 of U.S. Patent No. 10,640,811 involves measuring 5-methylcytosine instead).
However, Booth et al. teach that, in metazoa, 5-methylcytosine (5mC) can be oxidized to 5-hydroxy-methylcytosine (5hmc) which also constitutes an epigenetic mark (see paragraph [0002]). Booth et al. further teach measuring both 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) (see the whole document, e.g., Abstract; paragraphs [0002]-[0011]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to measure 5-hydroxy-methylcytosine (5hmc) (or measure both 5-methylcytosine (5mC) and 5-hydroxy-methylcytosine (5hmC)), as taught by Booth et al., in the claimed method of U.S. Patent No. 10,640,811 thus arriving at the instantly claimed invention, because: 1) the sequencing process in the claimed method of U.S. Patent No. 10,640,811 is a general or generic sequencing process that can be used for measuring any sequence variants or modifications including 5-hydroxy-methylcytosine (5hmC); 2) Booth et al. taught that, in metazoa, 5-methylcytosine (5mC) can be oxidized to 5-hydroxy-methylcytosine (5hmc) which also constitutes an epigenetic mark (see paragraph [0002]). Given the teachings of the prior art and the level of the ordinary skilled artisan at the effective filling date of the applicant’s claimed invention, it must be considered, absent evidence to the contrary, that said skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
4. Claims 22-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,287,624 in view of Booth et al. (US 2014/0178881 A1).
Regarding claims 22 and 25
Claim 1 of U.S. Patent No. 10,287,624 teach all the features of the instantly claimed method, except the use of the sequencing process for measuring 5-hydroxy-methylcytosine.
However, Booth et al. teach sequencing can be used to measure 5-hydroxy-methylcytosine (see the whole document, particularly Abstract; paragraphs [0004]-[0011]) which is produced by oxidation of 5-methylcytosine (which is a well-studied epigenetic DNA mark that plays important roles in gene silencing and genome stability) in metazoa and also constitutes an epigenetic mark (see paragraph [0002]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to use the sequencing process in the method as recited in claim 1 of U.S. Patent No. 10,287,624 for measuring 5-hydroxy-methylcytosine as taught by Booth et al. thus arriving at the instantly claimed invention, because: 1) the sequencing process in the method as recited in claim 1 of U.S. Patent No. 10,287,624 is a general or generic sequencing process that can be used for measuring any sequence variants or modifications including 5-hydroxy-methylcytosine; 2) Booth et al. taught that, in metazoa, 5-methylcytosine can be oxidized to 5-hydroxy-methylcytosine which also constitutes an epigenetic mark (see paragraph [0002]). Given the teachings of the prior art and the level of the ordinary skilled artisan at the effective filling date of the applicant’s claimed invention, it must be considered, absent evidence to the contrary, that said skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Regarding claims 23-24
According to Booth et al., the step of measuring 5-hydroxy-methylcytosine (i.e., bisulfite sequencing) comprises: an enrichment process to enrich for fragments of genomic DNA containing 5-hydroxy-methylcytosine (paragraphs [0003] and [0095]), and a bisulfite conversion process (Abstract; paragraphs [0004]-[0011]; claims 1-3 and 21).
Regarding claims 26-38
Claims 2-13 of U.S. Patent No. 10,287,624 further disclose all the additional features as recited in instant claims 26-38.
5. Claims 22-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,268,131 in view of Booth et al. (US 2014/0178881 A1).
Regarding claims 22 and 25
Claim 1 of U.S. Patent No. 11,268,131 teach all the features of the instantly claimed method, except the use of the sequencing process for measuring 5-hydroxy-methylcytosine.
However, Booth et al. teach sequencing can be used to measure 5-hydroxy-methylcytosine (see the whole document, particularly Abstract; paragraphs [0004]-[0011]) which is produced by oxidation of 5-methylcytosine (which is a well-studied epigenetic DNA mark that plays important roles in gene silencing and genome stability) in metazoa and also constitutes an epigenetic mark (see paragraph [0002]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to use the sequencing process in the method as recited in claim 1 of U.S. Patent No. 11,268,131 for measuring 5-hydroxy-methylcytosine as taught by Booth et al. thus arriving at the instantly claimed invention, because: 1) the sequencing process in the method as recited in claim 1 of U.S. Patent No. 11,268,131 is a general or generic sequencing process that can be used for measuring any sequence variants or modifications including 5-hydroxy-methylcytosine; 2) Booth et al. taught that, in metazoa, 5-methylcytosine can be oxidized to 5-hydroxy-methylcytosine which also constitutes an epigenetic mark (see paragraph [0002]). Given the teachings of the prior art and the level of the ordinary skilled artisan at the effective filling date of the applicant’s claimed invention, it must be considered, absent evidence to the contrary, that said skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Regarding claims 23-24
According to Booth et al., the step of measuring 5-hydroxy-methylcytosine (i.e., bisulfite sequencing) comprises: an enrichment process to enrich for fragments of genomic DNA containing 5-hydroxy-methylcytosine (paragraphs [0003] and [0095]), and a bisulfite conversion process (Abstract; paragraphs [0004]-[0011]; claims 1-3 and 21).
Regarding claims 26-38
Claims 2-21 of U.S. Patent No. 11,268,131 further teach all the additional features as recited in instant claims 26-38.
Conclusion
6. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684