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 Apr. 9, 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 Claims 39-40, 50-51, 54, 64, 66, 73, 75 and 78 are withdrawn.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.
Election/Restrictions
Applicant's election without traverse of Group I (Claims 1, 3, 5, 7-9, 11, 13 and 16-17), directed to an aqueous composition, in the reply filed on Apr. 9, 2026, is acknowledged. For the species election requirement, Applicant elects without traverse: 1) C5-C20 alkyl sulfate anion for the anionic detergent recited in claim 3, 2) HEPES for the first buffer reagent recited in claim 5, 3) succinic acid for the chelating agent recited in claim 11. Accordingly, claims 39-40, 50-51, 54, 64, 66, 73, 75 and 78 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group.
Claim Objections
Claims 5 and 11 are objected to because of the following informalities: these claims recite abbreviations without first spelling them out the first time they appear in the claims list. Appropriate correction is required.
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.
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 is directed to an “aqueous composition” comprising a first component that is specified by three reagents in w/v concentration ranges (i-iii) and a buffer (iv); claim 1 further specifies that the “aqueous composition” comprises a “diluting component” that can be water, a second buffer, a “Transport Medium”, a “Sodium Chloride (aq)”, or a combination thereof; claim 1 further specifies that the “first component” is diluted up to a maximum of about 50% (v/v) with the “diluting component”. Claim 1 is not clear in at least the following aspects.
A. Although the application uses the phrase “aqueous composition” throughout the disclosure, neither the specification nor the claims provide a clear and exclusive definition for this limitation. E.g., neither the specification nor the claims make it clear if the term “an aqueous composition” refers to one single aqueous solution or several separate aqueous solutions. As indicated above, the claimed “aqueous composition” is specified to comprise 5 distinct components (i.e., components i-iv comprised in the “first component” and a “diluting component”), each of them being described as if it was an individual solution (i.e., the 5 recited components are either described with a range of w/v concentration or referred to as a buffer/medium or simply water).
The presentation of the claimed elements in claim 1 appears to indicate that they are separate solutions. However, the claim specifies a process step of diluting the “first component” with the “diluting component”. This “diluting step” causes confusion.
Accordingly, it is not clear if the claimed “aqueous composition” is directed to a “composition” comprising the 5 separate reagents each in its own solution (as appearing to be specified in the claim), or if the claimed “aqueous composition” is directed to one single aqueous solution comprising all of the 5 recited reagents (and the recited concentration ranges being reduced by up to 50%).
Additionally, claim 1 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).
B. Claim 1 recites “a first buffer” and “a second buffer”. It is known in the art that the term “buffer” is a generic term referring to an aqueous solution that resists significant changes in pH when small amounts of a strong acid or base are added, or upon dilution. A buffer often comprises various reagents of its own. E.g., the PBS buffer contains Na2HPO4, KH2PO4, NaCl and KCl as ingredients. Many ingredients in “buffers” read on the elements (i)-(iii) recited in claim 1. Therefore, the terms “first buffer” and “second buffer” cause confusion since they may read on the elements (i)-(iii) recited in claim 1.
C. Claim 1 recites “Sodium Chloride (aq)” as an embodiment of “diluting component”. The specification does not define the term. Instead, it provides an example - In some preferred embodiments, the Sodium Chloride (aq) is 0.9% (w/v) Sodium Chloride. See [0062]. It is not clear what the term “Sodium Chloride (aq)” encompasses other than the “0.9% (w/v) Sodium Chloride” (solution).
Therefore, based on the descriptions above, it is not clear what the metes and bounds of claim 1 are. To facilitate examination, claim 1 is interpreted as reading on a combination of individual solutions comprising separately ingredients recited in the claim, with each ingredient having a concentration range as claimed.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
Moreover, claims 1, 7, 13 and 16 use the word “about” in specifying ranges. E.g., claim 1 recites “about 1% to 20% (w/v)”. It is not clear what the boundaries of those ranges are.
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.
Claims 1, 3, 5, 7-9, 11, 13 and 16-17 are 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).
The base claim 1 recites “An aqueous composition for storing a biological sample for subsequent nucleic acid testing, the composition comprising: a first component comprising: i) an anionic detergent in an amount from about 1 % to 20 % (w/v), ii) a Group I metal hydroxide in an amount from about 1 % to 5 % (w/v), iii) a chelating agent in an amount from about 0.5 % to 5 % (w/v), and iv) a first buffer, wherein the composition further comprises a diluting component selected from the group consisting of water, a second buffer, a Transport Medium, Sodium Chloride (aq), and combinations thereof, wherein the first component is diluted up to a maximum of about 50 % (v/v) with the diluting component.”
Claim 1 is interpreted as indicated in the 112(b) rejection above.
Smith teaches an invention relating to methods for isolating and storing nucleic acid from a sample containing nucleic acid, such as a cell sample or cell lysate. See Abstract. Smith teaches that various reagents can be included in solutions used in the invention. E.g., Smith teaches that the detergent used can be selected from sodium dodecyl sulfate (particularly 0.5%-5% weight-by-volume SDS), sodium lauryl sarcosinate (particularly 0.5%-5% w/v SLS), or other commercially available detergents, such as TWEEN™ 20 (particularly 0.5%-5% volume-by-volume TWEEN 20), lauryl dodecyl sulfate (particularly 0.5%-5% w/v LDS) or TRITON, e.g., TRITON X-100 (particularly 0.5%-5% v/v TRITON). See [0047].
Smith teaches that with regard to lysis of the cell nuclei, in one aspect of the invention, the nuclei are lysed, exploded, or ruptured to form a lysate containing nucleic acid by the addition of a low-salt, non-isotonic buffer, such as a hypotonic buffer; and that the low salt buffer may contain Tris, KCl and Mg2Cl. See [0150]-[0154]. Smith teaches that solutions containing 10mM Tris-HCI, 1 mM EDTA, pH 7.6-8 ("AE,"), or 10mM Tris-HCI, 0.1 mM EDTA, pH 8 ("TE-1"). See [0160].
Smith teaches that other suitable lysis solutions include any detergent containing solutions in which the detergent may be cationic, anionic or neutral. Chaotrope-containing solutions, preferably buffers may also be used. The lysis solution lyses or bursts open the condensed nuclear material to release the nucleic acid. See [0160].
Smith teaches that any solution at any pH which is suitable for eluting the nucleic acid from the present filter may work. Preferred elution solutions include sodium hydroxide (NaOH) (1 mM to 1 M), sodium acetate (Na acetate) (1 mM to 1M), 10 mM
2-[N-morpholino]-ethanesulfonic acid (MES) (pH 5.6), 10 mM 3-[cyclohexylamino]-1-propanesulfonic acid (CAPS) (pH 10.4), TE (10mM Tris HCL (pH8) + 1 mM EDTA), TE-1 (10 mM Tris; 0.1 mM EDTA; pH 8), sodium dodecyl sulfate (SDS) (particularly 0.5% SDS), TWEEN 20 (particularly 1 % TWEEN 20), LDS (particularly 1 % lauryl dodecyl
sulfate (LDS)) or TRITON (particularly 1 % TRITON), water and 10 mM Tris. See [0202].
Accordingly, Smith teaches various aqueous solutions that can be used in the invention, many of which comprising the ingredients as claimed. Here, sodium dodecyl sulfate (SDS) and lauryl dodecyl sulfate (LDS) are anionic detergents and read on C5-C20 alkyl sulfate of claim 3; NaOH is a Group I metal hydroxide; EDTA is a chelating agent; and Tris and MES are buffering agents.
Smith teaches that SDS may exist in a concentration between 0.5-5% (w/v), overlapping with the claimed concentration range of anionic detergent (1-20%). See above. However, Smith teaches different (working) concentrations for other reagents recited in the instant claims.
It would have been prima facie obvious for one of ordinary skill in the art at the time of invention to prepare aqueous solutions for the reagents used in the studies of Smith at any concentration, within purview of the researchers, including solutions containing the reagents of the current invention at the claimed concentration range. One would have been motivated to do so, e.g., to prepare stock solutions for each of the claimed reagents so that they can be mixed and/or diluted later to make working solutions.
Claims 5 and 11 are 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).
This rejection addresses the elected species of HEPES for the first buffer (buffering agent) recited in claim 5 as well as succinic acid for the chelating agent recited in claim 11.
Relevance of Smith is set forth above. However, it is silent on HEPES and succinic acid, even though Smith teaches other buffering and chelating agents.
Martens teaches an invention relating to processes for preparing and purifying protein from plant material, and compositions and uses comprising the same. See Abstract. It teaches various examples of buffering agents for use in the invention, including HEPES, in a group containing such bufferring agents as Tris, ACES, ADA, BES, MES, MOPS, MOPSO, PIPES, TES, Bis-Tris, Tricine, Bicine, etc. See [0085]. Martens further teaches various examples of chelating agents, including succinic acid, in a group containing other chelating agents such as EDTA, dexrazoxane, Prussian Blue, ALA, BAPTA, DTP A, DMPS, DMSA, EGTA, etc. See [0086].
Accordingly, teachings of Martens indicate that HEPES and succinic acid are known in the art at the time of invention as buffering agent and chelating agent, respectively, and can be used in preparation of solutions used biomolecule studies.
It would have been prima facie obvious for one of ordinary skill in the art at the time of invention to introduce the buffering agent HEPES and the chelating agent succinic acid, disclosed in Martens, into the studies of Smith (e.g., to make stock solutions comprising these reagents), to test the functions of these agents. Additionally, such a combination, or a substitution of one element for another known in the field to have the same function, is evidence that the claimed invention may be found obvious. See MPEP 2144.06 and KSR International v. Teleflex Inc., 82 U.S.P.Q.2d 1385, at 1395. Therefore, the instant 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.
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.
Claims 1, 3, 5, 7-9, 11, 13 and 16-17 are 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.
Although the conflicting claims are not identical, they are not patentably distinct from each other. Both sets of claims encompass an aqueous composition comprising: 1) an anionic detergent (lithium lauryl sulfate (LLS) of the patented claims is an anionic detergent), 2) a chelating agent (EDTA and EGTA of the patented claims), and 3) a buffering agent (sodium phosphate of the patented claims). The patented claims specify different concentration ranges of some of the recited agents than ones specified in the instant claims. The instant claims specify a group I metal hydroxide which the patented claims are silent on.
As indicated in the 112(b) and 103 rejections above, the instant claims are interpreted as reading on a combination of individual solutions comprising separately ingredients recited in the claims, with each ingredient having a concentration range as claimed.
One of skill in the art would have found it obvious to make individual solutions comprising the reagents specified in the patented claims as stock solutions to facilitate the preparation of working solutions containing these reagents. Such stock solutions can be made at any proper concentrations within the purview of the maker.
As to the group I metal hydroxide specified in the instant claims, the patented claims specify a pH range. It is known in the art that a group I metal hydroxide solution (e.g., a NaOH solution) is used in preparation of buffer solutions for pH adjustment (see Smith [0220]). Therefore, one of skill in the art would also find it obvious to obtain a group I metal hydroxide solution (e.g., NaOH) for pH adjustment based on teachings of Smith.
Therefore, the instant claims are obvious over claims 1-20 of US Patent 12071615.
Conclusion
No claims are allowed.
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
Prosecution Insights