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 .
DETAILED ACTION
This Office Action is in response to Applicants’ Amendment and Remarks filed on 10/14/2025 in which claims 11, 16, 18, 21, 23 and 24 are cancelled, claims 1 and 22 are amended and claims 25-34 are newly added. In addition, claims 13, 19 and 22 remain withdrawn as be directed towards non-elected invention.
Claims 3, 6-9, 12, 20 and 25-34 will be examined on the merits herein.
Priority
This application is a National Stage Application of PCT/EP2021/062856, filed on 5/14/2021. The instant application claims foreign priority to LU 101791, EP 20174550.2 and EP 20174548.6, all filed on 5/14/2020. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copies have been filed in the instant application on 12/17/2021.
Withdrawn Rejections
All rejection(s) of record for claim(s) 11, 16, 18, 21, 23 and 24 is/are hereby withdrawn due to the cancellation of said claim(s) rendering said rejection(s) moot.
Applicant’s amendment, filed on 10/14/2025, with respect to the rejection of claims 3, 6-9, 12, 20 under 35 U.S.C. 102(a)(1) as being anticipated by Gerdes et al. (US 2016/0289735A1) and claims 3, 7-9, 12, 20 under 35 U.S.C. 102(a)(1) as being anticipated by Brahmasandra et al. (US 2009/0131650A1), has been fully considered and is persuasive. Neither Gerdes not Brahmasandra disclose the presence of a clearing solution comprising the claimed cations. The rejections are hereby withdrawn.
Applicant’s amendment, filed on 10/14/2025, with respect to the rejection of claims 3, 6-8, 12, 20 under 35 U.S.C. 103 as being unpatentable over Fischer et al. (US 2009/0312285A1), has been fully considered and is persuasive. Fischer does not disclose or suggest the presence of a clearing solution comprising the claimed cations. The rejection is hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) or modified rejections necessitated by Applicants' amendment, filed on 10/14/2025, wherein instant independent claim 3 is amended, wherein the remaining pending claims depend from said independent claims, and claims 25-34 and newly added. Therefore, new grounds of rejection have been made or rejections from the previous Office Action, have been modified.
Modified Rejection
Claim Rejections - 35 USC § 103
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.
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 of this title, 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.
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 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.
Claims 3, 6-9, 12, 20, 25-28 and 30-34 are rejected under 35 U.S.C. 103 as being unpatentable over Gerdes et al. (US 2016/0289735A1, reference of record), in view of Mueller et al. (US 2020/0056169, filed 2018, reference of record).
Gerdes et al. discloses a process for isolating DNA from an in vitro sperm sample comprising contacting the sample with a composition comprising a lysis buffer with Tris HCl, 2% SDS and 40 mM tris(2-carboxyethyl) phosphine (TCEP), followed by binding a protamine-specific antibody to the lysed sperm cell, wherein the protamine-specific antibody binds to the protamine-DNA complex of the lysed sperm cell to form an antibody-protamine-DNA complex, followed by capturing the antibody-protamine-DNA complex; and isolating and detecting the sperm DNA from the captured antibody-protamine-DNA complex, where no enzyme was used in the process. (Abstract; ¶0039, 0066-0068; Figures 1-2; Claims 1-5) DNA was amplified and analyzed using PCR. (¶0063) Gerdes also teaches that: 1) the captured-antibody-protamine-DNA complex is incubated with the ion exchange resin at 95° C for at least 10 minutes to release the nucleic acids from the complex (¶0056); 2) the SDS detergent is sequestered in a further step comprising contact with Capto core 700 beads in a buffer solution comprising sodium ions (¶0047, 0070), which meets the instant limitation of a clearing solution comprising a cation.
Gerdes does not teach a clearing solution comprising the claimed cations.
Mueller teaches methods for isolating nucleic acids where a step of adding a clearing solution of 2.0M SrCl2 is disclosed. (¶0245, 0256-0261)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the SDS sequestration step of Gerdes, with the detergent precipitation using SrCl2 (i.e. “clearing”) of Mueller, thereby arriving at the instant invention. The SrCl2 of Mueller and the Capo beads of Gerdes, perform the same function of removing the detergent from the lysis solution, in order to purify the nucleic acid product prior to analysis/amplification. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the rejection over Gerdes/Mueller, has been fully considered but is not persuasive.
Applicant argues that the substitution of the CaptoCore beads of Gerdes with the clearing solution of Mueller is not prima facie obvious because one of ordinary skill in the art would not conclude that the two purification procedures are equivalent. Specifically, Applicant argues that the CaptoCore Beads of Gerdes are more sophisticated and allow for more control of which contaminants are removed from the mixture containing the desired nucleic acids, which is in contrast to the precipitation process using a clearing solution that does not allow for the sophistication of the CaptoCore beads.
Applicants’ argument is not persuasive because the goal of Gerdes in using the CaptoCore beads is removal of contaminants from the desired nucleic acid, to yield a purified nucleic acid. This is supported by the disclosure of CaptoCore 700 (Sigma-Aldrich, PTO-892), which discloses that the beads function for intermediate purification and polishing of viruses and other large biomolecules that allows efficient capture of contaminants while target molecules are collected in the flowthrough. (p. 4) The clearing solution of Mueller accomplishes the same goal of removing contaminants. This is supported by the disclosure of Ledent et al. (WO 2010/136503, PTO-892). Ledent et al. discloses that nucleic acid isolation procedures results in the presence of numerous contaminants (or impurities), such as endotoxins, phenols, caesium chlorides, ethidium bromides, surfactants and bound proteins, where such contaminants may be separated from the desired nucleic acids via selective precipitation with a hydrated salt selected from CaCl2, MgCl2, ZnCl2, SrCl2, BaC12, LiCl, ammonium acetate, ammonium sulfate, sodium sulfate or magnesium sulphate. (¶0005, 0012(c); Claim 1) Given the collective teachings of the prior art, it is prima facie obvious that the CaptoCore beads of Gerdes and the SrCl2 precipitation of Mueller are functionally equivalent means of separating contaminants from a desired nucleic acid and one method can be used in place of the other with an expectation of equivalent results. Simple because the CaptoCore beads may be a more technologically advanced and sophisticated, in comparison to precipitation, does not negate the ability of precipitation to accomplished the same goal of equivalently removing contaminants from a crude nucleic acid sample.
Applicant further argues that Gerdes teaches that the preferred lysis buffer comprises DTT (as reducing agent) and SDS (as surfactant), which if used in the instant method would render the process insufficient for the intended purpose because Applicant has data that DTT is inferior to TCEP. Applicants argument is not persuasive because the position of the Office is not to use the DTT of Gerdes but that Gerdes teaches that DTT and TCEP are equivalent reducing agents and that DTT could be substituted for TCEP, expecting equivalent results,. This conclusion is supported by Example 1, where it was noted that efficient lysis was observed with all reducing conditions, where both DTT/SDS and TCEP/SDS were examined as lysis solutions. Thus, in using TCEP as a reducing agent, one arrives at a reducing agent within the scope of claim 3 and would not run afoul of the purported inferiority of DTT.
The rejection is still deemed proper and is maintained.
New Grounds of Rejection
Claims 29 is rejected under 35 U.S.C. 103 as being unpatentable over Gerdes et al. (US 2016/0289735A1, reference of record), in view of Mueller et al. (US 2020/0056169, filed 2018, reference of record), further in view of Chen et al. (US 2009/0227011 A1, PTO-892).
The disclosure of Gerdes/Mueller is referenced as discussed above. The combined prior art does not teach a clearing solution comprising potassium, rubidium or cesium ions.
Chen et al. discloses selective precipitation, in a plasmid DNA purification process, where a solution comprising either ammonium ions, lithium ions, sodium ions, potassium ions, cesium ions or rubidium ions is used. (¶0023)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gerdes/Mueller and substitute the strontium ion clearing solution of Mueller with a clearing solution comprising rubidium or cesium ions, thereby arriving at the instant invention. One would be motivated to perform this substitution based on the disclosure of Chen that it is known in the art of nucleic acid purification that rubidium or cesium salt solution may be used for precipitation purification.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new and/or modified 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 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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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693