DETAILED ACTION
Status of the Claims
Claims 6, 8-10, and 24-30 are currently pending.
Claims 1-5, 7, and 11-23 have been canceled.
Claim 6 is amended.
Claims 25-30 are new.
Claims 6, 8-10, and 24-30 are the subject of this Office action.
The following Office Action is in response to Applicant’s communication dated 05/27/2025. Rejection(s) and/or objection(s) not reiterated from previous office actions are hereby withdrawn. The following rejection(s) and/or objection(s) are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/27/2025 has been entered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections – 35 U.S.C. 103(a)
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 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.
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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Brown
Claims 6, 8-10, and 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (WO 2016/040524 A1).
Regarding claims 6 and 25-30, Brown teaches a method for analyzing genomic DNA, comprising the steps of:
producing a DNA library by a method comprising extracting genomic DNA and conducting a nucleic acid amplification reaction in a reaction solution containing genomic DNA and a single set of primers which only consists of random primers each consisting of 9 to 14, or 16 to 30 nucleotides, using the genomic DNA as a template, to obtain DNA fragments by the nucleic acid amplification reaction, and, at a start of conducting the nucleic acid amplification, any and all nucleic acid matter of the reaction solution consists of the genomic DNA and the single set of primers, and preparing the reaction solution of the nucleic acid amplification reaction comprising the determined concentration of the random primers before conducting the nucleic acid amplification reaction, wherein the random primers consist of 9-14 or 16-30 nucleotides, the concentration of the single set of primers is set at the start of conducting the nucleic acid amplification (e.g., Rapid Nucleic Acid Library preparation method amplifying genomic DNA as per Fig. 1 and/or [0032] using a single set of primers that consists of a fixed 5’- 2-30mer and a random 3’- 5-10mer for a total size of 7-40mer as per [00152]-[00153] at a concentration of about 10 to about 150 µM as per [00326]),
determining all of the nucleotide sequences of DNA fragments contained in the produced DNA library by DNA sequencing, the nucleotide sequences each being of at least 100 nucleotides in length and detecting the presence or absence of particular DNA fragments in the DNA library based on the determined nucleotide sequences (e.g., “Substantially all of the sample sequence is represented in the library by multiple overlapping molecules” and is subsequently sequenced and compared to a reference as per [00183]-[0189]).
Note that the random primer concentration range disclosed by Brown encompasses the ranges recited in the claim (e.g., as per ¶0064) and in accordance with MPEP 2144.05(I), in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Further, as per In re Aller, Lacey, and Hall, 105 USPQ 233 (C.C.P.A. 1955), the court found that "More particularly, where the 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." Routine optimization is not considered inventive and no evidence has been presented that the selection of the claimed random primer lengths and concentrations was other than routine or that the results should be considered unexpected in any way as compared to the closest prior art.
Regarding claim 8, Brown teaches the above, wherein the presence or absence of the particular DNA fragments is confirmed based on the number of reads of the particular DNA fragments (e.g., as per [00183]-[0189]).
Regarding claim 9, Brown teaches the above, wherein the nucleotide sequences of DNA fragments contained in the DNA library are compared with known sequence information or with the nucleotide sequences of DNA fragments contained in a DNA library produced using genomic DNA from a different organism or tissue, and the presence or absence of the particular DNA fragments is confirmed based on differences in the nucleotide sequences (e.g., as per [00183]-[0189]).
Regarding claim 10, Brown teaches the above, further comprising the steps of preparing other primers and conducting a nucleic acid amplification reaction using genomic DNA extracted from a target organism as a template and the primers and confirming the presence or absence of the particular DNA fragments in the genomic DNA based on the results of the nucleic acid amplification reaction (e.g., as per [00194]).
Regarding claim 24, Brown teaches the above, wherein the nucleotide sequences are each of 100 to 500 nucleotides in length, (e.g., as per Fig. 2), and the DNA sequencing is by a next-generation sequencer (e.g., as per Fig. 2).
***
Response to Arguments
The 05/27/2025 remarks argue: claims are nonobvious.
Applicant's arguments have been fully considered but they are not persuasive for at least the following reasons.
Although the rejection herein is not based on any previously presented art, Applicant’s claims to criticality of their concentration ranges will be addressed. Specifically, the remarks at pages 6-7 assert that their “claim features were found to be unexpectedly advantageous, and therefore, impliedly critical”, pointing to the sections of the originally-filed specification at paragraphs [0007]-[0012], [0187], and “related descriptions”.
In response, it is first noted that as per MPEP § 2144.05 that "a prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness" citing In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). Furthermore, the same MPEP section states that “a modification of a process parameter may be patentable if it ‘produce[s] a new and unexpected result which is different in kind and not merely in degree from the results of the prior art" (citing Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As per MPEP § 716.01(c), allegations of unexpected results must be factually supported, such as by an appropriate affidavit or declaration to be of probative value. Arguments presented by the Applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Further, as per MPEP § 716.02, it is the burden of applicant to establish that their results are indeed unexpected and significant, to compare the claimed invention with the closest prior art, and to show that objective evidence of nonobviousness is commensurate in scope with the claims.
In the present case, the remarks point to the originally-filed specification at paragraphs [0007]-[0012], [0187], which generally alleges, inter alia, that the method of the invention can produce a DNA library “in a simple manner with excellent reproducibility”, that “genomic DNA can be analyzed in a cost-effective manner with high accuracy”, and that “a DNA library with a molecular size suitable for analysis with a next-generation sequencer can be produced with satisfactory reproducibility, and such DNA library can be suitable for marker analysis with the use of a next-generation sequencer.” There appears to be no discussion regarding if or how these results were unexpected and significant. Further, there was no comparisons to any prior art and no showing that the claimed invention is commensurate in scope with any alleged unexpected results. Notably, Applicant’s examples in the specification appear to use sets of 96 specific sequences of primers per primer length from 9 to 30 nucleotides (with six sets of 96 for length of 10 nucleotides), yet the claims are generically drawn to “random” primer sets whose compositions are not limited at all. For at least these reasons, Applicant’s arguments are not persuasive and the rejection is proper.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEREMY FLINDERS whose telephone number is (571)270-1022. The examiner can normally be reached M-F 10-6:00 EST.
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, Heather Calamita can be reached on (571)272-2876. 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.
/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684