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 with traverse of group I comprising claims 1 – 17 in the reply filed on 6/17/2026 is acknowledged. The traversal is on the ground(s) that each of the inventions are not independent and distinct (e.g., they share the same and/or overlapping subject matter) and that there would be no serious burden placed on the examiner during examination. This is not found persuasive because, as indicated in the previous restriction requirement, the inventions are indeed independent and distinct and have been accordingly separately classified. The primary classification of claimed subject matter is merely one indication of the burdensome nature of the search requirements and a serious burden on the examiner may also be shown by appropriate explanation of the field of search (see MPEP § 803). The restriction requirement merely refers to the primary classification for the inventions, not the complete scope of the prior art search in additional art class and subclass classifications or electronic database resources, or employing different search queries, that would be required in determining patentability. Furthermore, each of the inventions are drawn to different statutory classes of invention. Clearly, since each of the inventions comprise different features (e.g., additional chemical composition and/or distinct apparatus structure, and/or method steps), different searches and patentability determination issues are involved in the examination of each invention group. The requirement is still deemed proper and is therefore made FINAL.
Claims 18 – 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/17/2026.
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 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Cherukuri (US 2008/0020065 A1; hereinafter “Cherukuri”).
Regarding claim 1, Cherukuri teaches a viscous biological sample liquefying composition, comprising guaifenesin and a first strong base (magnesium hydroxide) (claims 1, 7 and 10; paragraphs 95 and 172).
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Giordano et al. (WO 2007/084331 A2; hereinafter “Giordano”).
Regarding claims 1 and 2, Giordano teaches a viscous biological sample liquefying composition, comprising guaifenesin and a first strong base (sodium) (see Example 1; claim 1).
Allowable Subject Matter
Claims 3 – 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, the cited prior art neither teaches nor fairly suggests that the viscous biological sample liquefying composition according to claim 1, further comprising rigid microparticles; wherein, the rigid microparticles are made of a material including at least one of zirconia, silicon nitride, ceramsite, hard stainless steel, hard tungsten carbide, sintered corundum or agate.
Regarding claim 4, the cited prior art neither teaches nor fairly suggests a liquefying agent, comprising the viscous biological sample liquefying composition according to claim 1; wherein the guaifenesin is of a concentration of 1 mmol/L to 1 mol/L and the first strong base is of a concentration less than 1 mol/L.
Regarding claim 6, the cited prior art neither teaches nor fairly suggests a viscous biological sample processing combination product comprising a liquefaction component, and further comprising a preservation component, a nucleic acid releasing component or a combination thereof; wherein the liquefaction component comprises the viscous biological sample liquefying composition according to claim 1; the preservation agent is a mixture consisted of the preservation component; and the releasing agent is a mixture consisted of the nucleic acid releasing component.
Regarding claim 12, the cited prior art neither teaches nor fairly suggests a viscous biological sample liquefying agent, comprising a liquefaction component, a Surfactin and a fourth aqueous solvent; wherein the liquefaction component comprises the viscous biological sample liquefying composition according to claim 1; the viscous biological sample liquefying agent is of a pH value equal to or greater than 10.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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