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 .
A Request for Continued Examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed 05 February 2026 has been entered.
The Request for Continued Examination filed has been considered. The following information has been made of record in the RCE filed for the instant application:
1. Claim 12 has been canceled.
2. No new Claims have been added.
3. Claims 1, 8 and 9 have been amended.
The following rejection has been withdrawn in view of the amendment to claim 1 and applicant’s remarks.
4. The rejection of Claim(s) 1-5 under 35 U.S.C. 102(a)(2) as being anticipated by Manning et al (WO 2018/213641; cited in IDS filed 08/30/2022; of record and necessitated by amendment) has been withdrawn in view of the amendment. Manning does not teach filtering the transport medium to isolate cells in the biological sample as in amended claim 1.
The rejection of Claim(s) 5-11 under 35 U.S.C. 103 as being unpatentable over Manning et al (WO 2018/213641; cited in IDS filed 08/30/2022; of record and necessitated by amendment) in view of Bogner et al (Extraction of Nucleic Acids. In: Coleman, W.B., Tsongalis, G.J. Eds, Molecular Diagnostics. Human Press, Chapter 3, pages 25-30; of record and necessitated by amendment) has been replaced by the rejection below under the same statute in view of the amendment.
Claims 1-11 are pending in the case. Support for the amendment is seen at page 9 of the specification.
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claim(s) 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Manning et al (WO 2018/213641; cited in IDS filed 08/30/2022; of record and necessitated by amendment) in view of Bogner et al (Extraction of Nucleic Acids. In: Coleman, W.B., Tsongalis, G.J. Eds, Molecular Diagnostics. Human Press, Chapter 3, pages 25-30) and further in view of Chen et al (CN 102191226 A, Machine English Translation, pages 1-8; newly cited necessitated by amendment).
One of the embodiments of Manning is that the biological sample is blood and the transport medium is amies medium (page 7, lines 3-12; as in claims 1-2). Manning et al teaches adding ammonium chloride to a blood sample (page 31, lines 32-37; limitations of claims 1, 4 and 5). Therefore, Manning’s teaching includes a biological sample in a transport medium as in claim 1. Since ammonium ion is added it should form a soluble complex with alkaline earth metals as in claims 1 and 3, and blood is a biological sample. In addition, Manning teaches a method of treating a biological sample present in Amies transport medium, which has both calcium and magnesium ions (Example 6 at page 68).
Manning teaches cell lysis for sample preparation and analysis for nucleic acids. Buffer components including citric acid can also be used (pages 31-33; page 31, lines 11-15-citric acid as buffer component; as in claim 7; and lysing as in claim 10).
Manning does not teach filtering the transport medium to isolate cells in the biological sample from the soluble complexes as in claim 1, the use of the other complexing agent as in claim 5, the limitations of claim 6, the other buffers as in claim 7 and the limitations of claims 8-9 and 11.
Bogner et al teaches that citrate specimen tubes provide good yields of nucleic acid appropriate for PCR and other assays (page 26; right col., part 2.3; citrate buffer component as in claim 7). Since citrate is suggested as a buffer, and ammonium ion addition is taught by Manning, one of ordinary skill in the art will use ammonium citrate as a complexing agent (as in claim 5). This should have a pH in the range recited in claim 6. In view of citrate anion being suggested as the complexing agent the artisan would find it obvious to use the other salts as in claim 5 and also the other ammonium ions as in claim 4 in combination with an anion like citrate and the others as complexing agent in the method. The artisan can substitute the other buffers as in claim 7 to keep the pH in the range as in claim 6.
Chen et al is drawn to separation of cells in a mixture using filtration. The filtering is done using a membrane filter which has a nominal pore size of 0.2 microns (para 0008; pore size as in claim 8). Even though Chen does not teach filtering a biological sample as in Manning, one of ordinary skill in the art can use the filter taught by Chen to filter the transport medium through the same type of filter to separate the cells in the transport medium from the soluble complexes and other unwanted material as in claims 1, 8 and 9. This would produce cells free of contaminants for further processing. Manning teaches lysing cells for analysis of nucleic acids. Therefore, it would be obvious to the artisan to lyse the cells on the membrane filter and elute the nucleic acid released during the lysis from the membrane filter as in claim 11.
Thus, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, Amies transport medium containing alkaline earth metal ions and a complexing agent has been used for detecting nucleic acids after performing cell lysis. Thus, it is obvious to use the same transport medium substituting the EDTA with ammonium ion in view of Manning and Bogner to perform the claimed steps and further elute the nucleic acids in view of the combined teachings of the prior art.
One of ordinary skill in the art will be motivated to use the claimed method since the reagents are known to be used for getting cell lysate containing nucleic acids (Manning) and citrate is known in the art to give good yields of nuclei acids (Bogner). According to Chen its filtration method saves labor and improves production efficiency (0022). The artisan would prefer to use a known method in the art which uses the claimed transport medium, the other agents and filtration to analyze nucleic acids and to further obtain them in good yields.
Response to Applicant’s Remarks
Applicant has traversed the rejection of claims under 35 USC 103 arguing that it was noted that Manning does not teach the filtering steps of claim 8, but it was obvious in view of Bogner. Bogner refers to precipitation and centrifugation. The Office does not provide any foundation for the obviousness of the filtering step of claim 8 in the context of forming soluble complexes with alkaline earth metals ions in a biological sample. In view of the foregoing arguments amended claim 1 and dependents thereof are patentable over the cited references (Remarks-page 4).
In view of the amendments the obviousness rejection as above is made of record.
Conclusion
1. Pending claims 1-11 (Group I) are rejected.
2. Claim 12 (Group II) has been canceled.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693