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 .
Claim Status
The amendment of 06/29/2026 has been entered. Claims 1-5, 7-9, 11-12, 15-16, 20, 22, and 24-28 are pending in this US patent application. Claim 5 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/24/2026.
Claims 1-4, 7-9, 11-12, 15-16, 20, 22, and 24-28 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 05/19/2026 has been received and considered.
Withdrawn Rejections
All rejections of claim 10 set forth in the previous Office action are withdrawn in light of the amendment of 06/29/2026, which canceled these claims.
The rejection of the claims under 35 U.S.C. 103 as being unpatentable over Holländer as set forth in the previous Office action is withdrawn in light of the amendment of 06/29/2026, which amended the concentration of cyanate or thiocyanate recited in claim 1.
Claim Rejections - 35 USC § 103
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 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.
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.
Claims 1-4, 7-9, 11-12, 15-16, 20, 22, and 24-28 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over US patent application publication 2013/0052721 filed by Holländer et al., published 02/28/2013.
Holländer teaches methods for isolating RNA from a sample (see entire document, including page 1, paragraph 0001). The first step of the method is degrading the sample (page 2, paragraph 0019), which is performed in the presence of degrading additives including Tris, inorganic salts, and reducing agents such as DTT, along with a proteolytic enzyme, at least one detergent, and at least one chaotropic agent (page 2, paragraphs 0025-0033; cf. claims 1, 12, and 26-28). The pH of the solution is preferably between 4 and 9 (page 2, paragraph 0035; cf. claim 20). The salts may include NaCl, KCl, MgCl2 or CaCl2, and the concentration of salt present in the solution is dependent upon the proteolytic enzyme used and may be determined by the skilled person (page 2, paragraph 0035; cf. claims 12 and 15). The detergent may be SDS (page 3, paragraph 0039; cf. claims 1-4 and 24-25), the buffering agent may be TRIS (page 3, paragraph 0040; cf. claims 1 and 16), and the chaotropic agent, which may be used in combination with the proteolytic enzyme and the detergent, may be sodium thiocyanate at a concentration of from about 50 mM up to the saturation limit (page 3, paragraph 0041; cf. claims 1, 7-9, and 11; the Examiner notes that a solution containing sodium thiocyanate in the recited concentrations as the only chaotropic agent, as suggested by Holländer, would satisfy the ratio requirements of instant claim 1 and be free of urea and guanidinium, thus satisfying instant claims 7-9). In specific embodiments, the Tris buffer was used at a concentration of 20 mM (page 11, paragraph 0108; cf. claim 22).
However, Holländer does not specifically teach an embodiment of a composition containing all of the recited ingredients in the recited amounts, the recited amount of thiocyanate, or the amount of the ionic salts present in the degradation solution.
While Holländer does not specifically teach an embodiment of a composition at pH 4-9 containing 20 mM TRIS; SDS; sodium thiocyanate at a concentration of from about 50 mM up to the saturation limit; reducing agents such as DTT; a proteolytic enzyme; and a salt such as NaCl, KCl, MgCl2 or CaCl2 at a concentration dependent upon the proteolytic enzyme used that may be determined by the skilled person, it would have been obvious to one of ordinary skill in the art to do so because Holländer suggests all of these ingredients for a composition for degrading samples to isolate RNA. One of ordinary skill in the art would have a reasonable expectation that formulating a composition at pH 4-9 containing 20 mM TRIS; SDS; sodium thiocyanate at a concentration of from about 50 mM up to the saturation limit; reducing agents such as DTT; a proteolytic enzyme; and a salt such as NaCl, KCl, MgCl2 or CaCl2 at a concentration dependent upon the proteolytic enzyme used that may be determined by the skilled person, as suggested by Holländer, and then incubating a biological sample containing RNA in said composition would successfully result in the degradation of the sample and release of RNA.
Holländer does not teach the amount of ionic salt recited in instant claim 15 or the amount of thiocyanate recited in instant claim 1. However, the instantly recited concentrations would be within the realm of routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here 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 Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of salt and chaotropic agent present in the degradation solution because the concentration of the salt and the chaotropic agent in the degradation solution is an art-recognized, result-effective variable known to affect the activity of the proteolytic enzyme in the solution, as taught by Holländer, which would have been optimized in the art to provide the desired level of activity.
Therefore, claims 1-4, 7-9, 11-12, 15-16, 20, 22, and 24-28 are rendered obvious by Holländer and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant has traversed the previous rejection of the claims under 35 U.S.C. 103 as being unpatentable over Holländer. Applicant states that the prior art does not teach or suggest the 10-25 mM concentration range recited in amended claim 1 (remarks, pages 5-7). This argument has been fully considered but has not been found persuasive.
As discussed above, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here 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 Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of salt and chaotropic agent present in the degradation solution because the concentration of the salt and the chaotropic agent in the degradation solution is an art-recognized, result-effective variable known to affect the activity of the proteolytic enzyme in the solution, as taught by Holländer, which would have been optimized in the art to provide the desired level of activity.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
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 Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Tuesday-Thursday, 6:30-4:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 09/09/2026
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