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 and substitute specification filed 7-21-2026 has been entered into the record. Claims 2-4 and 6-7 have been cancelled. Claims 1, 5, 8-14 are pending and under examination.
The text of Title 35 of the U.S. Code not reiterated herein can be found in the previous office action.
Objections/Rejections Withdrawn
The objections to the disclosure because of informalities is withdrawn in view of the amendments.
The rejection of claims 3-5 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the amendment to the claims.
The rejection of claims 1, 2, 3, 6, 7, 8, 9, and 11-14 under 35 U.S.C. 102(a)(1) as being anticipated by Grier et al (Molecular Therapy – Nucleic Acids 5:e306 pages 1-10, 2016; of record on PTOL-1449) is withdrawn in view of the amendment to the claims.
The rejection of claims 9 and 10 under 35 U.S.C. 103 as being unpatentable over Grier et al (Molecular Therapy – Nucleic Acids 5:e306 pages 1-10, 2016; of record on PTOL-1449) in view of Rahimzadeh et al (Molecular Biology Research Communications 5(4):257-261, 2016) is withdrawn in view of the amendment to the claims.
Rejections Maintained
Claims 1, 5, 8, 9 and 11-14 stand rejected under 35 U.S.C. 103 as being unpatentable over Grier et al (Molecular Therapy – Nucleic Acids 5:e306 pages 1-10, 2016; of record on PTOL-1449) in view of Corchero et al (Biotechnology and Bioengineering 58(6:625-632, 1998) for reasons made of record in the Office Action mailed 4-21-2026 for claims 1-9 and 11-14.
Applicant’s arguments have been carefully considered but are not persuasive. Applicant argues that the combination does not teach each and every element of the claimed invention as Grier et al is drawn to a linear plasmid for generating mRNA in vivo transcribed templates with extended encoded poly(A) sequences. This is not persuasive; the claims are not drawn to circular plasmids and do not exclude the use of linear plasmids for generating mRNA in vivo. It is noted that the claims do not require in vitro transcription of the plasmid. Applicant ignores the teachings of pWNY recovery at 30oC in a liquid recovery medium/broth and plating on selective plates at 25oC and subsequence analysis of the polyA tail as set forth in Greir et al. As previously provided: it would have been prima facie obvious at the time of filing to one having ordinary skill in the art at the time of filing to modify the method of Grier et al to further culture clones of in a liquid medium and subculture the transformants of Grier et al at the desired temperature as the skilled artisan recognizes that the process of culturing clones of interest and subculturing is conventional and routine practice in bacterial cultivation and molecular biology to provide more bacterial cells comprising a clone having a plasmid of interest for preservation, study or further experimentation. Grier et al specifically teach that conventional routine procedures can be used. Conchero et al teach that plasmid maintenance is influenced by the length of the cloned segment, the growth temperature and the plasmid copy number giving specific motivation to optimize the temperature conditions of the process to produce the pWNY plasmid having the polyA tail. Although the specifics of the liquid culture and subculture are not set forth it is shown that 25oC was sufficient for growth and plasmid maintenance. Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, the prior art combination does teach the specific combination. Therefore, Applicant’s arguments drawn to Grier et al, and Corchero et al individually, are inapposite. “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.” In re Alter, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case, the culturing temperature at 25oC is known and the art teaches that temperature, length of the cloned segment and plasmid copy number were variables to be optimized for plasmid maintenance. Applicant argues the stability of poly(a) tails on plasmids and argue Example 2 of the specification and that the combination is critical to maintain that a greater proportion of colonies maintained the intended 124- adenine poly(a) tail during transformation in culture. This is not persuasive as the claims are not limited to 124-mers and can be as small as 2 with no upper limit. The polyA tail is not limited and can be less than that provided. The method of Grier et al provides for approximately full-length polyA tails of 100 and 200-mers using the 30oC recovery and subsequent 25oC incubation on solid media (see Figure 3) The subsequent incubation and subculture in liquid culture is prima facie obvious. The lower recovery temperature and lower subcloning and culture temperatures were known to the art and subject to routine optimization. The criticality of the specific parameters argued by Applicant have not been demonstrated to be critical to the breadth of the “cell line” which can include any plasmid and any cell, including mammalian systems. The criticality of the temperature has not been generalized to any cell line or any plasmid or combination thereof. As such, Example 2 of the specification is not commensurate in scope with the claims. The rejection is therefore maintained.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Grier et al (Molecular Therapy – Nucleic Acids 5:e306 pages 1-10, 2016; of record on PTOL-1449) in view of Corchero et al (Biotechnology and Bioengineering 58(6):625-632, 1998) as applied to claims 1-9 and 11-14 above and further in view of Rahimzadeh et al (Molecular Biology Research Communications 5(4):257-261, 2016) or reasons made of record in the Office Action mailed 4-21-2026 for claims 9 and 10.
Applicant essentially argues that the combination of Grier et al in view of Corchero et al fails, so does the combination over Rahimzadeh et al. This is not persuasive; the rejection of Grier et al in view of Corchero et al does not fail for reasons set forth above. The rejection is therefore maintained.
Status of Claims
All pending claims stand rejected.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
