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 .
The amendment filed 10 June 2026 has been received, entered and considered. The following information has been made of record in the instant amendment:
1. No Claims have been canceled.
2. No new Claims have been added.
3. Claims 10 and 16 have been amended.
4. Remarks drawn to claim objection and rejection under 35 USC 103.
The following objection has been overcome:
The objection to claim 15 has been overcome by amendment.
Claims 1-16 are pending in the case. Claims 1-9 have been withdrawn from consideration as being drawn to a non-elected invention. Claims 10-16 are under prosecution.
The following rejections are necessitated by Applicant's amendment filed 10 June 2026 wherein the limitations in pending claims 10 and 16 have been amended. Support for the amendment is seen at para 0072 in the specification and claim 16.
Claim Rejections - 35 USC § 112
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.
Claim 10 is 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.
Claim 10 recites ‘dissolving the cationic polymer from the polymer thin film of the container’. The polymer including a hydrolysable side chain is disposed as a thin film in the container. When the thin film of the polymer is dissolved it is the whole polymer having the hydrolysable side chain that is dissolved. It is no clear what ‘dissolving the cationic polymer from the polymer thin film of the container’ means.
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) 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Gap et al (KR20200092691 A; Machine English Translation, pages 1-31; cited in IDS filed 08/21/2023; of record) in view of Rolph et al (Polymer Chemistry, 2017, 8, 5060-5070; cited in IDS filed 04/29/2025; of record) and further in view of Ros et al (ACS Omega, 2020, 5, 9114-9122; cited in IDS filed 04/29/2025; of record) and Wahlund et al (Biotechnology and Bioengineering, 2004, 87(5), 675-684; of record).
The invention of Gap et al deals with polymer thin film for capturing nucleic acids in polymers. A polymer obtained by reacting monomer containing vinyl group, an acryl group or a methacrylic group and an amine group having a positive charge is used for the nucleic acid capture (Abstract; paras 0011, 0014-0016, 0052; part of the limitations of claim 10 regarding cationic polymer for capture of nucleic acid by electrostatic attraction). Various monomers can be used. One of them is dimethylaminoethylmetharylate (DMAEMA; para 0031). This is structurally close to DMAEA as in claim 15. The use of a linear polymer comprising a repeating unit polymerized from DMAEA as in claim 15 is rendered obvious. From the teaching of Gap, it is seen that a polyplex can be formed between a cationic polymer having a side chain and a nucleic acid.
Gap does not teach dissolving the cationic polymer with nucleic acid, precipitating the polyplex formed and hydrolyzing the polymer to release the nucleic acid from the polyplex as in claim 1, and does not teach the limitations of claims 11-14 and 16.
Rolph et al teaches that hydrolysis of polymers having a dimethylaminoethyl chain was significantly faster at 50oC (page 5065, left col; Fig. 5). From this teaching of Rolph one of ordinary skill in the art would have a reasonable expectation of success in hydrolyzing the cationic polymer to release the nucleic acid when the hydrolysis of the polyplex is performed at 30-50oC as in claim 11. Rolph also teaches that hydrolysis is more than 30% at 50oC for an hour (page 5065, Fig. 5a; limitation of claim 14).
According to Wahlund et al precipitation based on the formation of insoluble polyelectrolyte complexes is a powerful technique for capturing nucleic acids (Abstract; step 2 in claim 10). Wahlund teaches that solutions of nucleic acid and the polycation were mixed and shaken vigorously (page 677 right col., last para). In view of this and the teaching of Gap regarding polymer thin film for capturing nucleic acid in polymers, it would be obvious to the artisan to form a thin film of the cationic polymer in a container and disposing the sample including the nucleic acid in the container and dissolving the polymer thin film to combine the dissolved cationic polymer with the nucleic acid by electrostatic attraction as in claim 10. This is well within the skill level of the artisan to recognize and perform.
Ros et al teaches that polymers with DMAEA and having a positive charge form a complex with nucleic acid and also hydrolyze at pH 7, and an increase in temperature to 37oC will also increase the rate of hydrolysis (page 9116, right col. First sub-heading; page 9117, right col. last sub-heading through page 9118, left col.). This teaching in view of Rolph tells one of ordinary skill in the art that a cationic polymer having a hydrolysable side chain like DMAEA can be dissolved and complexed with nucleic acid, precipitated, and the side chain containing the nucleic acid can then be hydrolyzed to release the nucleic acid from the polyplex as in claim 10. From the teaching of Ros above it can be seen that since an increase in temperature to 37oC will also increase the rate of hydrolysis the cationic polymer should be combined with the nucleic acid at a temperature of 10oC or more and less than 30oC as in claim 12. Ros teaches a hydrolysable cationic ester as a side chain (page 9115, Scheme 1; as in claim 16). This ester chain after hydrolysis will produce the moiety Me2N+HCH2CH2O- which has a negative charge (page 9115 Scheme 1; as in claim 13). Even though Ros teaches polymers having a number average molecular weight in the range of 23,000 g/mol to 26,000 g/mol (page 9117, Table 1), the artisan would have a reasonable expectation that a cationic polymer having a number average molecular weight of 1000g/mol to 3000g/mol without crosslinks can be made and used in the method as in claim 10.
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, cationic polymers are known to form polyplexes with nucleic acids which can be precipitated. Hydrolysis of the side chain of the cationic polymer complex with nucleic acid is also known in the art.
Thus, the claimed invention as a whole would have been 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. One of ordinary skill in the art would be motivated to use the claimed method (also obvious over the combined teachings of the prior art) since Wahlund teaches there is demand for highly purified nucleic acids. Complex formation and efficient removal of contaminants results in high recovery of pure nuclei acids. The complex formation as taught by Gap and Wahlund with a cationic polymer having a hydrolysable side chain and the hydrolysis of such a side chain as taught by Rolph and Ros will give pure nucleic acids and the method also requires fewer steps compared to lysis and chromatography which require more steps and use of large volumes of solvents (Wahlund-Introduction).
Response to Applicant’s Remarks
Applicant has traversed the rejection of claims 10-16 under 35 USC 103 of record arguing that the cited references do not disclose or suggest “disposing a sample including nucleic acid in a container having a polymer thin film, which includes a cationic polymer having a hydrolysable side chain”, and the effects of the invention as claimed cannot be achieved by disclosures of the cited references. Particularly, since the polymer thin film disclosed in Gap has a crosslinked structure, a polymer cannot be dissolved from the polymer thin film. Rolph and Ros use a polymer thin film.
Further, the cationic polymer has a number average molecular weight of 1000g/mol to 3000g/mol. The cited references do not disclose this molecular weight range. Particularly, in Gap the polymer has a cross-linked structure. The polymer is supposed to have a very high molecular weight. In Rolph and Ros the disclosed copolymer has a molecular weight of more than 20,000g/mol. Wahlund does not disclose the molecular weight of the polymer. The claimed molecular weight is lower than that of the polymers used in the reference. The cited references co not suggest dissolving the polymer from a polymer thin film. Thus, the cited references do not provide motivation to achieve the above-limited molecular weight. Accordingly, the present claims are in a condition for allowance. (Remarks-pages 6-8).
Applicant’s arguments are not persuasive. The references may not expressly teach “disposing a sample including nucleic acid in a container having a polymer thin film, which includes a cationic polymer having a hydrolysable side chain”. However, Gap et al deals with polymer thin film for capturing nucleic acids in polymers, and also teaches cationic polymers as instantly claimed for the capture.
Wahlund teaches that solutions of nucleic acid and the polycation were mixed and shaken vigorously. In view of this and the teaching of Gap regarding polymer thin film for capturing nucleic acid in polymers, it would be obvious to the artisan to form a thin film of the cationic polymer in a container and disposing the sample including the nucleic acid in the container and dissolving the polymer thin film to combine the dissolved cationic polymer with the nucleic acid by electrostatic attraction as in claim 10. This is well within the skill level of the artisan to recognize and perform.
Applicant has argued that the polymer thin film disclosed in Gap has a crosslinked structure, a polymer cannot be dissolved from the polymer thin film, whereas Rolph and Ros use a polymer thin film. Claim 10 is drawn to the use of a polymer thin film, the polymer thin film including a cationic polymer having a hydrolysable side chain. This is a board recitation and which includes crosslinked polymers and non-crosslinked polymers. Applicant is arguing that the polymer thin film disclosed in Gap has a crosslinked structure, a polymer cannot be dissolved from the polymer thin film. This is just a statement by the applicant. Applicant has not shown that the crosslinked polymer cannot be dissolved nor has any support for the statement provided.
Moreover, in the rejection it has been stated that even though Ros teaches polymers having a number average molecular weight in the range of 23,000 g/mol to 26,000 g/mol (page 9117, Table 1), the artisan would have a reasonable expectation that a cationic polymer having a number average molecular weight of 1000g/mol to 3000g/mol without crosslinks can be made and used in the method as in claim 10. There is a reasonable expectation of success for the same. Motivation has also been given in the rejection.
The combined teachings of the prior art render the instant claims obvious. The rejection is maintained.
Conclusion
1. Elected claims 10-16 (Group II) are rejected.
2. Group I Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
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 GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
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