DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-12 and 18-19) in the reply filed on 06/15/2026 is acknowledged.
Claims 1-19 are currently pending.
Claims 13-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/15/2026.
Claims 1-12 and 18-19 have been examined on their merits.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-10, and 18 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Lader et al (US 2001/0016312-from IDS filed 03/12/2024).
Regarding claims 1, 4-10, Lader discloses a biological material preservation composition (Methods and reagents for preserving RNA in cell and tissue samples, Title) comprised of ammonium sulfate (AmSO4), a pH buffer, and a chelator (The term "RNAlater is a trademark of Ambion, Inc., for certain commercial formulations of the RNA preservation media disclosed herein the term "RNAlater is employed to denote the formulation disclosed in Example 2, which is composed of 25 mM Sodium Citrate, 10 mM EDTA, 70 g ammonium sulfate/100 ml solution, (page 5, Para. [0046], page 7 [0075], [0076]), See Applicant's disclosure, Pg. 4, lines. 19-21, which identifies sodium citrate as an example of an acceptable buffer and EDTA as an example of an acceptable chelator).
Regarding claim 2, Lader discloses the composition of claim 1, wherein the composition comprises from about 4.54 M to 6.05 M of AmSO4 (The term "RNAlater TM" is a trademark of Ambion, Inc., for certain commercial formulations of the RNA preservation media disclosed herein the term "RNAlater™" is employed to denote the formulation disclosed in Example 2, which is composed of 25 mM Sodium Citrate, 10 mM EDTA, 70 g ammonium sulfate/100 ml solution, (page 5, Para. [0046], page 7 [0075], [0076]), where 70 g ammonium sulfate/100 ml is equivalent to 5.2974 M ammonium sulfate).
Regarding Claim 3, Lader discloses the composition of claim 2, wherein the composition comprises about 5.75 M of AmSO4 (The term "RNAlater™ is a trademark of Ambion, Inc., for certain commercial formulations of the RNA preservation media disclosed herein the term "RNAlater is employed to denote the formulation disclosed in Example 2, which is composed of 25 mM Sodium Citrate, 10 mM EDTA, 70 g ammonium sulfate/100 ml solution, Paras. [0046], [0075], [0076], where 70 g ammonium sulfate/100 ml is equivalent to 5.2974 M ammonium sulfate and is "about" 5.75 M as indicated by Applicant Specification (page 2, lines 8-13).
Applicant has defined the term “about” at page 2 lines 8-13 of their Specification, and indicates that “about 5.75M includes 5.75 molar as well as 6.61 M and 4.89 M, and all 1/10 values in between”.
Regarding claim 18, Applicant as defined the term “collection tube” as referring to any suitable containment method or device for containing a water sample of biological materials (Applicant’s Specification page 3, lines 11-12).
Lader disclose their preservation composition is contained in a beaker with sterile water (page 7 para 76) which is deemed to be a suitable device for containing a water sample of biological materials. Lader also disclose an embodiment wherein their preservation composition is provided in premeasured aliquots in a vial in a collection kit for preserving RNA and packaged for shipment (pages 4-5 para 39).
Therefore, the teaching of Lader anticipates Applicant’s invention as claimed.
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.
Claim(s) 1, 8-12, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Walenciak et al (US 2004/0043505) in view of Simpson (Cold Spring Harbor Protocols, 2010).
Regarding claims 1 and 8-11, Walenciak disclose a method and device for collecting and stabilizing a biological sample using a pre-filled container with 5.6-37.5 mM of EDTA (abstract, page 2 para 23, page 7 claim 1). Additional additives may also be included with the EDTA to help stabilize the biological sample and include salts and buffer (pages 3-4, para 35-36). Since the reference range of 5.6-37.5 overlaps and includes the claimed concentrations of EDTA, the claimed concentrations are rendered obvious.
Walenciak do not specifically include an embodiment wherein the EDTA is combined with a salt, such as ammonium sulfate, and a buffer.
Simpson disclose compositions and methods for the stabilization of proteins for storage (Title and Introduction). Simpson disclose that solvent additives, such as ammonium sulfate, can significantly stabilize the biological activity of proteins (page 9). Simpson also disclose the use of buffers as well (page 4).
One of ordinary skill in the art would have been motivated to include ammonium sulfate and a buffer as additives in the EDTA-containing composition of Walenciak because Simpson teach and suggest solvent additives, such as ammonium sulfate, can significantly stabilize the biological activity of proteins and that the addition of buffers is suitable as well. One of ordinary skill in the art would have had additional motivation and a reasonable expectation of success in adding ammonium sulfate and a buffer to the EDTA-containing composition of Walenciak because Walenciak specifically suggests that the addition of salts and buffers that would help stabilize the biological sample would be beneficial to their composition.
Regarding claim 12, Walenciak disclose wherein their EDTA composition can be present in solid form (page 3 para 26) such as a freeze-dried powder (page 4 para 38). Simpson disclose that a preferred method of preparation and stabilization is to convert a product into a solid state by freeze-drying (page 9).
One of ordinary skill in the art would have been motivated to freeze-dry an EDTA, ammonium sulfate and buffer composition in the method of Walenciak because Simpson teach and suggest that this is preferred in the case of therapeutic and diagnostic protein products and Walenciak is also drawn to a therapeutic and diagnostic protein product. One of ordinary skill in the art would have had additional motivation and a reasonable expectation of success in providing a solid freeze-dried product because Walenciak also suggest a solid freeze-dried powder is an option as well.
Regarding claims 18-19, Walenciak teach and suggest that their EDTA-containing composition is packaged in a collection device that is typically sterile (page 3 para 30) and also specifically include blood collection tubes (page 2 para 12, para 15).
Therefore, the combined teachings of Walenciak et al and Simpson render obvious Applicant’s invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Camacho-Sanchez et al., “Preservation of RNA and DNA from mammal samples under field conditions”, Molecular Ecology Resources, 2013, Vol. 13, pp. 663-673.
(full article, including appendix, regarding an EDTA, ammonium sulfate and buffer composition)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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