DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 20, 2026, has been entered.
Claim Disposition
3. Claims 2-3, 9-10, 18 and 21 are cancelled. Claims 25-27 have been added. Claims 1, 4-8, 11-17, 19-20 and 22-28 are pending. Claims 1, 4-8, 11-17, 19-20 and 22-25 and are under examination. Claims 27-28 are withdrawn as directed to a non-elected invention. Newly submitted claims 27-28 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: because the method does not per se utilize the kit). Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 27-28 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
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, 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.
4. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
5. Claim(s) 1, 4-8, 11-17, 19-20 and 22-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO1999027082A1 (Hansen, of record in the application) in view of Cascao-Pereira (US 2013/0005029,of record in the application), further in view of WO1994002597A1 (Svendsen, of record in the application) and Jiang et al. (US Patent No. 9006419, 2015), McFall et al. (US2018/0016623, of record in the application) and Hogan et al. (US Patent No. 7786289, 2010) and Covid Nasal Swab kit (July 8, 2020).
The primary reference teaches detergent compositions with detergent builders and stabilizers, and anionic surfactant is present at a level from 0.1% to 60% by weight and enzymes such as proteases (subtilisin), lipases, cutinases and amylases (see page 29, line 19; page 30, lines 10-37, page 32, line 18; page 10 lines 9-10; page 42, lines 6-30; page 43, paragraph 2 and page 51). Chelators, EDTA, Trilon M, trisodium citrate and EGTA are disclosed (see page 42, lines 6-10). The detergent of the primary reference is present in less than 10% (see page 37, lines 1-14), which renders obvious the “about 3 and 6%” in the claims. The primary reference does not provide a kit with a swab, however, the art generally recognizes that kits are for ease of a method. In so far as the primary reference is absent teaching of a kit the secondary reference provides a kit with enzyme and buffer solution (see paragraphs [0519-0520]). The secondary reference also discloses variants of alpha amylase that can be used as additives to detergents or oral care products (see paragraphs [0008, 0011]), with 0%- about 20% humectant; 0% to about 2% surfactant; 0% to about 5% enzymes; 0% to about 20% ethanol and up to about 70% water. The tertiary reference teaches a kit for nucleic acid diagnostic and isolation and comprises a composition with a detergent (see abstract). The tertiary reference discloses the isolating agent further comprises a salt, a detergent, a protease, and/or a solid support (see detailed description (10). Moreover, the fourth reference teaches methods, kits (abstract) and systems for processing biological samples which includes detection and extraction of the nucleic acid (see abstract) and the reference provides a kit containing the composition (for example, see abstract).The fifth reference teaches a protease (such as proteinase K) in a DNA extraction method that utilizes a kit (see abstract and paragraph [0073]). The fifth reference discloses SDS (paragraph [0011]), among others and salts and surfactants (see paragraphs [0011 and 0073]). The fifth reference teaches a phosphate buffer (see paragraph [0006 and 0102]) and cation chelator such as EDTA (see paragraph [0104]). The fifth reference by McFall et al. teaches a tube with a cap (see paragraph [0015]) and diagnostic test comprises nucleic acid extraction, amplification and detection (see abstract and paragraph [0005]). McFall also teach that the swab (see paragraph [0051]) can be used for nasal purposes (see paragraphs [0009 and 0011]). The sixth reference teaches DNA extraction and isolation, the use of a kit, nasal swab and lithium lauryl sulfate salt (see paragraphs 24, 35 and 39). Thus the claimed invention is obvious and within the skill of the ordinary artisan and would be obvious to use lithium lauryl sulfate (LDS) and subtilisin as components together in molecular biology kits for isolating nucleic acids (RNA/DNA) from biological samples, particularly tissues since LDS is an anionic detergent used to lyse cells and denature proteins and preferred over sodium dodecyl sulfate (SDS) for applications at lower temperatures, as it is more soluble. Further the art generally recognizes that subtilisin is a protease (enzyme) used to degrade and remove proteins that may interfere with nucleic acid purification. Additionally, nasal swab kit containing a flexible plastic stem, flocked tip, subtilisin, and lithium lauryl sulfate (LLS) is designed for the collection, stabilization, and transport of clinical specimens, primarily for respiratory virus testing, including COVID-19 (i.e. flexible plastic stem swab: the swab typically features a nylon flocked tip, which is designed to maximize the collection and release of biological materials. The art generally discloses that the subtilisin break down proteins in the sample, which can help release pathogens from mucus and the lithium lauryl sulfate (LLS) / DNA/RNA. This component acts as a strong lysis buffer, breaking open viruses and bacteria to release their genetic material (DNA/RNA), while simultaneously inactivating nucleases (enzymes that degrade RNA/DNA). The Covid test kits utilize surfactants in conjunction with nasal swabs. The usage of HEPES buffer, one of Good’s zwitterionic buffer is established in the art and commonly used in cell culture medium, thus this can be construed as an obvious design choice and within the skill of the ordinary artisan in the field.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the combined teaching of the references render the claimed invention as obvious. One of ordinary skill in the art would be motivated to combine the references because they are analogous art. The primary reference discloses the claimed composition but not a kit or swab and these deficiencies are disclosed in the secondary, tertiary and fourth reference. Note that the fourth reference provides the kit with swab and biological sample for the expressed purpose as claimed in a nasal sample and the fifth reference teaches the same salt claimed in a DNA extraction with a nasal swab and kit. Nasal swabs with flexible plastic stem and flocked tip were utilized to collect Covid/Sars samples and in kits utilized by clinicians (see the attached pamphlet). Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Response to Arguments
6. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the art rejection of record remains but has been modified based on amendments made to the claims. Applicant traverses the rejection and indicated that the claims have been amended to obviate this ground of rejection. This argument is not persuasive because the limitations such as flexible plastic stem is not novel and was practiced during Covid.
Conclusion
7. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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