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 .
ELECTION
2. Applicant’s election without traverse of Group I in the reply filed on 12/05/25 is acknowledged.
3. Claims 8, 10, 12, 15, 17-19, 22, 25-26, 28, and 30-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/05/25.
4. Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
OBJECTION
5. Claims 1-3, 5, and 7 are objected to because independent claim 1 uses incorrect capitalization in each of steps a) - f). Correction is required.
NON-PRIOR ART REJECTION
6. 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 1-3, 5, and 7 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.
Claims 1-3, 5, and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the relation between the sample, the template DNA, and host cell DNA in independent claim 1. Without clarification, the purpose and function of the claimed method cannot be understood, because the disclosed method (Example 1 in the specification, for example) only applies with respect to specific types of a sample, a template DNA, and host cell DNA. For example, claim 1 does not recite any source of host cell DNA, so it cannot be determined what such DNA is present and where it came from. It is suggested that claim 1 be amended to clarify the nature of the sample, template DNA, and host cell DNA in accordance with the disclosed method. It is well settled in U.S. patent prosecution that while claims are to be read in light of the specification, limitations are not to be improperly read into the claims.
These claims are further indefinite because it cannot be determined what is encompassed by steps d), e), and f) because there is no nexus between these generating, comparing, and identifying steps and the prior steps a) – c). Clarification is required as to how these steps are performed and accomplish their intended purpose.
ALLOWABLE SUBJECT MATTER
7. Due to the severe indefiniteness issue discussed above, the current claims cannot be properly compared with the prior art. However, for the sake of completeness it is noted that no prior art has been found teaching or suggesting the method as disclosed in Example 1 of the specification in which a polyanionic PCR inhibitor such as PVS is quantitated indirectly by PCR, in the disclosed manner using a dilution series and a spiked exogenous control template DNA, in a sample comprising a biologic produced in cell culture, for the purpose of determining if the sample is suitable for accurate PCR detection of undesirable, contaminating residual host cell DNA in the sample by PCR, wherein a sufficient concentration of polyanionic PCR inhibitor in said sample would compromise accurate PCR detection of said residual host cell DNA in said sample. Zheng et al. (2019) teaches using qPCR to detect undesirable residual host cell DNA in samples comprising biopharmaceutical products. Zhang et al. (2010) teaches a quantitative method for measuring PVS impurities in biological samples, as it was known that PVS may interfere with enzyme activity and cause protein precipitation. Kontanis et al. (2006) teaches using qPCR efficiency as a means of detecting PCR inhibitors to identify problematic samples. No prior art has been found teaching or suggesting combining or modifying the teachings of these references in such a way as to achieve the disclosed method.
CONCLUSION
8. Soto (US 2023/0400442) is made of record as a reference of interest.
9. No claims are allowable.
10. 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.
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01/23/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681