DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 04/13/2026 is acknowledged. Regarding the Office action mailed 01/14/2026, the rejections set forth therein under 35 USC 103 based on the combination of Kuhns, Ney and additional references are withdrawn in view of the amendment, particularly the amendment to claim 1 reciting "wherein the determining whether or not the ratio conforms to a predetermined value or range is performed as a quality control measure to validate measurement accuracy by confirming an expected chromosomal copy number relationship between the first gene and the pseudogene". Kuhns did not determine a ratio of copy number of gene to pseudogene as a quality control measure.
New grounds of rejection are set forth for certain of the new claims added by the amendment.
Claim Objections
Claims 1-3, 5-12 and 13-22 are objected to because of the following informalities: in claim 1, line 10, “during the PCR or a after the PCR” should read “during the PCR or after the PCR”, or alternatively, “during or after the PCR”.
In addition, the language “a value not within any range” in the first “determining” step should be changed to “a value not within any predetermined range”, since any value would occur within an infinite number of different ranges.
In addition, in the interest of clarity, it is recommended that the first section of the claim enumerate the options, e.g., “…and the DNA solution contains (i) a single fluorescent-labeled probe…,or (ii) a DNA intercalator…”. A similar recommendation is made for claim 10.
In the calculating step, it is recommended to delete the word “placed” in the language “a double strand DNA placed in the partition”. The current language seems to indicate that a double strand DNA is actively “placed” into the partition, when in fact the intent is that a double strand DNA is generated in the partition, either as a double strand PCR product, or as a probe hybridized to a PCR product. Therefore, the language “a double strand DNA in the partition” would be preferred. For similar reasons, in claim 10, in the section beginning with “a melting temperature memory”, it is recommended to delete the word “placed” in the language “a double strand DNA placed in the partition”.
As all other claims depend ultimately from claim 1, they are objected to for the same reasons. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 21 is 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.
The scope of the claim is indefinite, as it cannot be understood what “information is reflected in accuracy control of digital PCR” entails.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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.
/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
Prosecution Insights