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
Acknowledgement is hereby made of receipt and entry of the communication filed on Aug. 13, 2026. Claims 1, 3, 5, 7-9, 11, 13, 16-17, 39-40, 50-51, 54, 64, 66, 73, 75 and 78 are pending. Claims 39-40, 50-51, 54, 64, 66, 73, 75 and 78 are withdrawn. Claims 1, 3, 5, 7-9, 11, 13 and 16-17 are currently examined.
Information Disclosure Statement
The information disclosure statement submitted on May 29, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. The IDS contains Foreign Patent Documents and/or Non-Patent Literature Documents that are not in English language. The documents not provided in English language are considered only to the extent of the Examiner’s capacity of the related for foreign language and the English language submission. An initialed and dated copy of Applicant’s IDS form is attached to the instant Office action.
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.
(Previous Rejection – Maintained and Modified Necessitated by Amendment) Claims 1, 3, 5, 7-9, 11, 13 and 16-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The base claim 1, as amended, recites:
An aqueous composition for storing a biological sample for subsequent nucleic acid testing, the composition comprising:
i) an anionic detergent in an amount from 1 % to 20% (w/v),
ii) a Group I metal hydroxide in an amount from 1 % to 5 % (w/v),
iii) a chelating agent in an amount from 0.5 % to 5 % (w/v), and iv) a first buffer,
wherein the composition is diluted to a maximum of 50% (v/v) with a diluting component, the diluting component selected from the group consisting of water, a second buffer, a Transport Medium, Sodium Chloride (aq), and combinations thereof.
Claim 1 is indefinite in at least the following aspects.
A. Claim 1 is directed to an aqueous composition and further recite a process of diluting the composition. The claim recites product and process in the same claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05 (p). Here, it is not clear if the aqueous composition as claimed is limited to the composition specified in i)-iv) of claim 1, or if the aqueous composition as claimed comprises a composition containing the components of i)-iv) and those introduced by the diluting component, which are vaguely specified.
B. The limitation of claim 1 “wherein the composition is diluted to a maximum of 50% (v/v) with a diluting component, the diluting component selected from the group consisting of water, a second buffer, a Transport Medium, Sodium Chloride (aq), and combinations thereof” is not clear. First, it is not clear how to interpret the phrase “diluted to a maximum of 50% (v/v) with a diluting buffer” since it only gives one diluting scenario, that is to 50% (v/v), it is not clear what other diluting conditions the limitation also encompasses. E.g., it is not clear if the limitation reads on a situation where no dilution is made. Secondly, it is not clear how the v/v ratio of dilution is to be calculated.
C. Claim 1 recites “a first buffer” and “a second buffer”. The specification defines the term “buffer” as referring to a weak acid or weak base used to maintain the pH of a solution. This definition renders to claim unclear because it is not clear what the terms “weak acid” and “weak base” exactly refer to in claim 1. E.g., it is not clear if the terms refer to the pure forms of “weak acid” and “weak base”, or if they also encompass solutions containing the “weak acid” and/or “weak base”.
To facilitate examination, claim 1, as claimed, is interpreted as reading on a range of dilutions from no dilution to a 50% (v/v) with a diluting component, which can be water or other solutions, and the rate of 50% (v/v) is considered as reading on 1:1 (v/v) dilution.
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 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.
(Previous Rejection – Withdrawn) Claims 1, 3, 5, 7-9, 11, 13 and 16-17 were rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2006/0094015 A1, published on May 4, 2006, of record in the previous Office action).
(Previous Rejection – Withdrawn) Claims 5 and 11 were rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2006/0094015 A1, published on May 4, 2006), in view of Martens et al. (US 2022/0259259 A1, published on Aug. 18, 2022; PCT filed on Jul. 10, 2020).
The above rejections are withdrawn in view of the amendment filed on Aug. 13, 2026. Applicant’s arguments regarding the withdrawn rejections are moot.
(New Rejection – Necessitated by Amendment) Claims 1, 3, 5, 7-9, 11, 13 and 16-17 rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 2009/0227011 A1, published on Sep. 10, 2009), in view of Smith et al. (US 2006/0094015 A1, published on May 4, 2006), Martens et al. (US 2022/0259259 A1, published on Aug. 18, 2022; PCT filed on Jul. 10, 2020), and Adams, D.S. (CSH Protocols; 2008; Vol. 3, Issue 5, May 2008; doi:10.1101/pdb.ip55).
The base claim 1, as amended, is directed to an aqueous composition for storing a biological sample for subsequent nucleic acid testing, the composition comprising: i) an anionic detergent in an amount from 1 % to 20% (w/v), ii) a Group I metal hydroxide in an amount from 1 % to 5 % (w/v), iii) a chelating agent in an amount from 0.5 % to 5 % (w/v), and iv) a first buffer, wherein the composition is diluted to a maximum of 50% (v/v) with a diluting component, the diluting component selected from the group consisting of water, a second buffer, a Transport Medium, Sodium Chloride (aq), and combinations thereof.
Interpretation of claim 1 is presented in the 112(b) rejection above. It is noted that the previous interpretation that claim 1 reads on a combination of individual solutions comprising separately ingredients recited in the claim, with each ingredient having a concentration as claimed, is withdrawn in view of the current amendment.
Chen teaches an invention relating to methods for purifying plasmid DNA from host cells. After a standard lysis procedure that releases plasmid DNA from the host cells, two sequential precipitation procedures separate plasmid DNA from essentially all impurities of the host cells. See Abstract. Chen teaches solution I and solution II used in plasmid extraction. One of the original Sol. I compositions was a mixture of 2 mg/ml lysozyme, 50 mM glucose, 10 mM cyclohexane diamine tetraacetate (CDTA), and 25 mM Tris-HCl, with a solution pH of 8.0, although many other re-suspension solutions are now well known and more preferred. One of the original Sol. II compositions was a mixture of 0.2 N NaOH and 1 % sodium dodecyl sulfate (SDS), although any solution capable of lysing host cells can be used. See [0007].
Chen teaches that Sol. I and Sol. II can be combined into a single formulation, referred to as Solution A ("Sol. A") (see [0030]), and that Solution A can comprise 50 mM Tris-HCl, 10 mM EDTA, 0.2 N NaOH and 1 % SDS and Solution B comprises 2.0 M acetic acid, 0.6 M potassium acetate, 0.4 M calcium chloride, and 0.4 M manganese chloride (see [0032]).
Here, Solution A comprises all ingredients specified in claim 1. I.e., i) an anionic detergent, SDS, in 1% (w/v), ii) a Group I metal hydroxide, NaOH, in a concentration of 0.2 N, which corresponds to 0.8% (w/v), iii) a chelating agent, EDTA, in a concentration of 10 mM, which corresponds to 0.372% (w/v), and iv) a first buffer agent, Tris-HCl, in a concentration of 50 mM, which corresponds to a concentration of 0.788% (w/v). However, the concentration of ingredients ii) and iii), NaOH and EDTA, in the solution A are slightly below the claimed ranges, i.e., 0.8% (w/v) vs. 1%-5% (w/v) and 0.372% (w/v) vs. 0.5%-5% (w/v), respectively.
Relevance of Smith and Martens is set forth in the withdrawn 103 rejections in the previous Office action. Briefly, Smith and Martens together teach various chemical ingredients that can be used in handling of nucleic acids, including anionic detergents (SDS and LDS), NaOH, chelating agents (EDTA, EGTA, etc.), and buffering agents (Tris, HEPES, MOPS, etc.). See in the previous Office action. Teachings of Smith and Martens provide evidence that various chemical agents, including those as instantly claimed, are known to be used in the handling of nucleic acid molecules, and that they can be used at various different concentrations, preferred or not. See e.g., [0220], [0231] and Table 1 of Smith.
Adams teaches that to minimize the volume actually occupied by these solutions, they are often made at a higher concentration than that which will be used, that these concentrated solutions are referred to as stock solutions, and that stock solutions save time in addition to space; when one needs a solution of a given concentration, one needs only dilute the stock rather than starting from scratch. See INTRODUCTION. Adams further teaches that making a stock solution is just like making any solution; one simply scales up the concentration of all of the ingredients, that typical stock solutions are 2X, 5X, and 10X, meaning double, five times, and ten times the normal concentration, respectively, and that the upper limit to the concentration of a stock solution is set by the solubility of the chemicals in the required solvent. See OVERVIEW.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the current invention to arrive at the invention as claimed from the combined teachings of Chen, Smith and Martens. One would have been motivated to do so, e.g., to modify the concentrations of the ingredients of solution A of Chen, in a routine experimental optimization, to evaluate how increasing the concentrations of NaOH and EDTA for a little bit would change the properties of the solution. Additionally, one of skill in the art would have also found it obvious to make a stock solution for the solution A of Chen, based on the teachings of Adams. In this case, a 2x stock solution of the solution A of Chen would land the concentrations of all in the ingredients in the claimed ranges.
Double Patenting Rejection
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 double patenting rejection is appropriate where the claims at issue 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 reference 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. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(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.
(Previous Rejection – Withdrawn) Claims 1, 3, 5, 7-9, 11, 13 and 16-17 were rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US Patent 12071615 in view of Smith et al. (US 2006/0094015 A1, published on May 4, 2006), cited in the art rejections above.
This rejection is withdrawn upon reconsideration.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN, on (571) 270-3497, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIANXIANG ZOU/
Primary Examiner, Art Unit 1671
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