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 .
OBJECTIONS
2. The specification is objected to because of the following informality: the continuation information must be updated to indicate the issue of the parent ‘640 application as US 11,926,866.
3. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
4. Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
NON-PRIOR ART REJECTIONS
5. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A) Claims 7-8 are indefinite because ‘the cleavage site’ in claim 7 lacks proper antecedent basis. Correction is required.
B) Claim 9 is indefinite because ‘the 3’ oxygen atom’ lacks proper antecedent basis. Correction is required.
C) Claim 10 is indefinite because ‘the blocking group’ lacks proper antecedent basis. Correction is required.
PRIOR ART REJECTIONS
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
8. Claims 1-10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walder et al. (US 2009/0325169).
Regarding independent claim 1, Walder discloses a blocked-cleavable primer for rhPCR comprising 5’-A-B-C-D-E-3’, wherein A is optional, B is complementary to a target, C is a discrimination domain, D is a cleavage domain comprising an RNA base which is cleavable by RNase H2, and E is a blocking domain.
Regarding claim 2, Walder discloses separation of the RNA base from the discrimination domain by one base position.
Regarding claim 3, Walder discloses that the RNA base is within the discrimination domain.
Regarding claim 4, Walder discloses that the RNA base is adjacent to the discrimination domain.
Regarding claim 5, Walder discloses that the cleavage domain is 1-3 RNA bases.
Regarding claim 6, Walder discloses that the cleavage domain comprises DNA, abasic residues, modified nucleosides, or modified phosphate internucleotide linkages.
Regarding claims 7-8, Walder discloses the use of internucleoside linkages that are resistant to nuclease cleavage, including phosphorothioate.
Regarding claim 9, Walder discloses substitution of an RNA residue with an amino, thiol, or methylene group.
Regarding claim 10, Walder discloses attachment of the blocking group to the 3’-terminal of the primer.
Regarding claim 12, Walder discloses overlap between the discrimination and cleavage domains.
See Figs. 18 and 27, and paragraphs 0027-0034 and 0116-0172.
The claimed primer cannot be distinguished from the primer of Walder.
9. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
10. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
11. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
12. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Walder in view of Spier et al. (WO 2014/110528).
The teachings of Walder are discussed above.
Walder does not disclose a primer comprising at the 5’-end a tail extension not complementary to a target nucleic acid that has a region identical to a universal forward primer.
Spier discloses, for the purpose of facilitating sequencing by NGS, the use of blocked primers comprising at the 5’-end a tail extension not complementary to a target nucleic acid that has a region identical to a universal forward primer. See Fig. 8 and paragraph 0056.
One of ordinary skill in the art would have been motivated to modify the primer of Walder by adding a 5’-end tail extension not complementary to a target nucleic acid that has a region identical to a universal forward primer because Spier disclosed that such a 5’-end tail extension was useful in facilitating sequencing by NGS. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to make and use the claimed primer.
CONCLUSION
13. No claims are free of the prior art.
14. Behlke et al. (WO 2015/073931) is made of record as a reference of interest.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
08/18/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
Prosecution Insights