Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 2-20 are pending in the application. Claim 1 has been canceled. Preliminary amendment filed 27 September 2024.
Priority
This application is a continuation of 17/088,000 filed 11/03/2020, now U.S. Patent No. 12,077,752 which is a continuation of 16/038,071 filed 07/17/2018, now US Patent No. 10,858,645, which is a continuation of 15/813,979 filed 11/15/2017, now US Patent No. 10,053,685, which is a continuation of 15/409,189 filed 01/18/2017, now US Patent No. 9,850,480, which is a continuation of 14/296,732 filed 06/05/2014, now US Patent No. 8,771,948, which is a continuation of 13/262,624 filed 03/01/2012, now US Patent No. 8,771,948, which is a 371 of PCT/US2010/029653 filed 04/01/2010 which claims the benefit of 61/166,671 filed 04/03/2009. The parent application 61/166,671 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 2-20 of this application. Priority accorded is 04/03/2009.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hawkins (US 5,705,628) in view of Bastian et al (6,180,778) and further in view of Woodard et al (US 5,674,997).
Hawkins teaches a method of separating nucleic acids, wherein the nucleic acids can comprise molecules of various lengths (col. 1, lines 24-29, col. 2, lines 24-25, and col. 6, line 67 through col. 7, line 5; method as in claim 2, and limitations of claim 2, parts ii and iii). The method comprises contacting the nucleic acid containing composition with a solid phase, wherein the nucleic acids, relatively long and relatively short, are bound to the solid surface and then exposing the solid phase to dissociation conditions wherein the said conditions is contacting with a salt solution which can be sodium chloride. The solid phase can con contain iron oxide (col. 2, line 64 through col. 3, line 8; limitation of claim 14). Subsequently, the microparticles enriched in the relatively short nucleic is separated (col. 1, lines 38-63, col. 2, lines 34-60, col. 5, line 28 through col. 6, line 27, col. 7, lines 11-38 and claims 9-13 of Hawkins; as in claim 2, part a(i), part b, and limitation of claims 3 and 6-7-salt). The solid phase is a collection of particles and does not contain a functional group that interacts with the nucleic acid (col. 1, line 35, col. 2, line 63; limitation of claims 10 and 12). The reagent added to the solid surface is salt which can be sodium chloride (col. 2, lines 39-45, col. 5, lines 47-48; limitation of claims 6-7 and 17). An embodiment of the invention also a method is wherein the nucleic acid fragments bound to the particles are washed and then eluted and collected (col. 7, lines 25-37). This is a suggestion that the dissociated nucleic acids can be transferred to a vessel that does not contain the solid phase as in claim 18. Hawkins teaches separating the magnetic particles of the solid surface from the elution buffer containing the dissociated nucleic acid by centrifugation (col. 4, lines 37-45; as in claim 20).
In addition, Hawkins teaches that yields of bound DNA drop as concentration of PEG deviate from 10% and also that the salt concentration and PEG concentration can be adjusted for reversible binding of DNA to the surface (col. 5, lines 29-35 and lines 64-65). In view of this teaching of Hawkins, one of ordinary skill in the art would use association conditions without polyethylene glycol (as in claim 2, part iv). Hawkins also teaches separation of nucleic acids of various sizes. Therefore, the artisan would find it obvious and would also have a reasonable expectation of success in enriching relatively short nucleic acids having the base pairs as in claims 15-16. Hawkins teaches that the magnetic microparticles are attracted by a magnetic field and can be separated by applying a magnetic field (col. 2, lines 58-67). This teaching renders obvious the use of a magnet to separate the solid phase from the dissociated nucleic acid using a magnet (as in claim 19).
Hawkins does not expressly teach the use of association conditions without PEG as in claim 1, part (iv) and the limitations of claims 4-5, 8-9, and 11.
Bastian et al, drawn to separation of nucleic acids, teaches that for binding ss nucleic acids and ds nucleic acids on a support by adjusting the treatment conditions with an appropriate aqueous mixture of salts, especially chaotropic salts and an alcohol like ethanol. The chaotropic salt can be a guanidinium salt (GTC; col. 2, line 56 through col. 4, line 43; as in claims 4-5 and 8-9). The artisan can use this in the method of Hawkins with a reasonable expectation of success.
Woodard et al teaches the use of silicas for DNA purification/enrichment (see Abstract; as in claim 11). According to Woodard, the solid surface can have a charge, not too high, to permit DNA elution (col. 2, lines 25-52). In view of this teaching the artisan would use a solid phase having a net charge in the method of Hawkins (as in claim 13).
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, the steps and reagents/components used are known in the art for separating nucleic acid as claimed. Thus, it is obvious to arrive at the claimed method. The claimed invention as a whole is prima facie obvious over the combined teachings of the prior art. Process improvement is the motivation. Moreover, Hawkins teaches its method is useful for separating a wide range of polynucleotides (col. 1, line 64 through col. 2, line 1). Not using PEG in in step 2(a)(iv) also reduces the cost of the method.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 8,771,948 (‘948), as being unpatentable over claims 1-12 of U.S. Patent No. 9,580,741 (‘741), as being unpatentable over claims 1-20 of U.S. Patent No. 9,850,480 (‘480), as being unpatentable over claims 1-18 of U.S. Patent No. 10,053,685 (‘685), and as being unpatentable over claims 1-21 of U.S. Patent No. 10,858,645 (‘645). Although the conflicting claims are not identical, they are not patentably distinct from each other because:
Instant Claim 2 is drawn to a method for separating nucleic acid comprising contacting a nucleic acid composition with a solid phase under association conditions wherein the nucleic acid composition comprises short nucleic acid and long nucleic acid, the short nucleic acid is 200 base pairs or less, the long nucleic acid is greater than 200 base pairs, the association condition does not include PEG, whereby the short and long nucleic acid associate with the solid phase and dissociating and separating the short nucleic acid from the solid phase. Dependent claims 3-20 recite limitations drawn to salts and alcohols used in the association conditions (claims 3-9), solid phase is collection of particles and particles being silica and having net charge and are paramagnetic (claims 8-14), short nucleic acids having specific range for base pairs (claims 15-16), dissociating using volume exclusion agent and/or a salt, separating the solid phase by a magnet, transferring dissociated nucleic acid to an environment without the solid phase and wherein the environment is a vessel, and separating nucleic acid from solid phase via centrifugation (claims 17-20).
The claims of ‘948, ‘741, ‘480, ‘685 and ‘645 are also drawn to the same method using the same steps. The dependent claims recite limitations that are seen in the instant dependent claims.
The claims of ‘948, ‘741, ‘480, ‘685 and ‘645 differ from the instant claims in that the instant claims recite a composition having short nucleic acids having 200 base pairs or less and long nucleic acids larger than 200 base pairs, while the claims of the ‘948, ‘741, ‘480, ‘685 and ‘645 patents recite 300 base pairs or less for the short nucleic acid and greater than 300 base pairs for the long nucleic acids.
In the instant case the cited patents teach performing each of the steps applicant claims. Although the claims of the cited patents teach a composition having different base pair sizes in the starting composition, one of ordinary skill in the art would readily recognize that the scheme taught by the patents could be employed in the claimed method with a reasonable expectation of success. The use of known steps and reagents in a method of enrichment of relatively short nucleic acids taught in the prior art is not seen to render the instantly claimed method unobvious over the art. Once the general scheme has been shown to be old, the burden is on the applicant to present reason or authority for believing that the use of a different base pair size would alter the nature of the product or the operability of the process and thus the unobviousness of the method of using it.
Claims 2-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable claims 1-19 of U.S. Patent No.12,077,752 (‘752) in view of Hawkins (US 5,705,628) in view of Bastian et al (6,180,778) and further in view of Woodard et al (US 5,674,997). Although the conflicting claims are not identical, they are not patentably distinct from each other because:
Instant Claim 2 is drawn to a method for separating nucleic acid comprising contacting a nucleic acid composition with a solid phase under association conditions wherein the nucleic acid composition comprises short nucleic acid and long nucleic acid, the short nucleic acid is 200 base pairs or less, the long nucleic acid is greater than 200 base pairs, the association condition does not include PEG, whereby the short and long nucleic acid associate with the solid phase and dissociating and separating the short nucleic acid from the solid phase. Dependent claims 3-20 recite limitations drawn to salts and alcohols used in the association conditions (claims 3-9), solid phase is collection of particles and particles being silica and having net charge and are paramagnetic (claims 8-14), short nucleic acids having specific range for base pairs (claims 15-16), dissociating using volume exclusion agent and/or a salt, separating the solid phase by a magnet, transferring dissociated nucleic acid to an environment without the solid phase and wherein the environment is a vessel, and separating nucleic acid from solid phase via centrifugation (claims 17-20).
The claims of ‘752 are also drawn to the same method using some of the same steps. The dependent claims recite limitations that are seen in the instant dependent claims.
The claims of ‘752 differ from the instant claims in that the instant claims include chaotropic salt and/or alcohol for the association condition, while the claims of ‘752 includes specific volume exclusion agents including and does not include a chaotropic salt.
The teachings of the secondary references are set forth above, which suggest the use of chaotropic salt and alcohol in a method of separating nucleic acids.
In the instant case ‘752 teaches performing each of the steps applicant claims. Although the claims of ‘752 teach the use of volume exclusion agents and no chaotropic salts, one of ordinary skill in the art would readily recognize that the scheme taught by 752 could be modified in view of the secondary references to arrive at the claimed method with a reasonable expectation of success. The use of known steps and reagents in a method of separating nucleic acids taught in the prior art is not seen to render the instantly claimed method unobvious over the art. Once the general scheme has been shown to be old, the burden is on the applicant to present reason or authority for believing that the use of salt and/or alcohol and chaotropic salt would the operability of the process and thus the unobviousness of the method of using it for nucleic acid separation.
Conclusion
1. Pending claims 2-20 are rejected.
2. Claim 1 has been canceled.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693