Prosecution Insights
Last updated: October 02, 2026
Application No. 17/995,138

STABILIZING COMPOSITION AND METHOD FOR PRESERVING A BODILY FLUID

Final Rejection §101§103§112
Filed
Sep 30, 2022
Priority
Mar 30, 2020 — provisional 63/002,123 +1 more
Examiner
MOSS, NATALIE M
Art Unit
1653
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Dna Genotek Inc.
OA Round
2 (Final)
31%
Grant Probability
At Risk
3-4
OA Rounds
0m
Est. Remaining
48%
With Interview

Examiner Intelligence

Grants only 31% of cases
31%
Career Allowance Rate
161 granted / 523 resolved
-29.2% vs TC avg
Strong +17% interview lift
Without
With
+17.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
56 currently pending
Career history
599
Total Applications
across all art units

Statute-Specific Performance

§101
7.9%
-32.1% vs TC avg
§103
45.6%
+5.6% vs TC avg
§102
13.3%
-26.7% vs TC avg
§112
28.8%
-11.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 523 resolved cases

Office Action

§101 §103 §112
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 OFFICE ACTION This Office Action is in response to the papers filed on 09 July 2026. CLAIMS UNDER EXAMINATION Claims 1-2, 5, 8, 14-18, 35-37, 40, 43, 49-50 and 52 have been examined on their merits. PRIORITY Provisional Application 63/002,123 filed on 30 March 2020, is acknowledged. WITHDRAWN REJECTIONS The rejection made under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been withdrawn due to claim amendment. The rejection claims 8, 15 and 43 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, has been withdrawn due to claim amendment. Claim 36 has been amended to require a bodily fluid comprising stabilized cells. The rejection of claims 36-37, 40, 43 and 49-50 under 35 U.S.C. 103 as being unpatentable over Fischer et al. in view of Porter et al. and Daum et al. has been withdrawn due to claim amendment. REJECTIONS Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-2, 5, 8, 14-18, 35-37, 40, 43, 49-50 and 52 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more as evidenced by Mussio et al. (The role, mechanisms and evaluation of natural chelating agents in food stability: a review. Food Chemistry. Volume 496, Part 1, 25 December 2025, pages 1-13). Question 1: Are the claims directed to a process, machine manufacture or composition of matter? Yes, claims 1 and 36 are directed to a composition of matter. Question 2A: Are the claims directed to a product of nature, a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? Prong 1. Yes, claims 1 and 36 are directed to a nature-based product limitation. The limitation that sets forth a nature based product in claim 1 is: a composition comprising a monosaccharide/disaccharide, a buffering agent, a C1-C6 alkanol, boric acid and a chelating agent. The limitation that sets forth a nature based product in claim 36 is: a composition comprising a monosaccharide/disaccharide, a buffering agent, a C1-C6 alkanol, boric acid, a chelating agent and a bodily fluid containing stabilized cells. The nature based products lack markedly different characteristics (and thus are product of nature exception) because: When the claimed components are compared to their naturally occurring counterparts they are not markedly different than the judicial exceptions themselves. Each component encompassed by the claimed compositions reads on a judicial exception. The claims encompass all monosaccharides and disaccharides. Glucose (a monosaccharide) is a naturally occurring sugar (a judicial exception). The claims encompass all buffering agents. As evidenced by the specification, citrate is a buffer (PG Pub [0050]). Citrate is naturally occurring (a judicial exception). The claims encompass all C1-C6 alkanols. Ethanol is a known naturally occurring alkanol (a judicial exception). The claims encompass boric acid. Boric acid is naturally occurring compound of boron, oxygen and hydrogen which is derived from boron. It is a judicial exception. The claims encompass all chelating agents. As evidenced by Mussio et al., polysaccharides are naturally occurring chelating agents (judicial exceptions; see page 4, left column, first paragraph). Claim 36 has been amended to recite a bodily fluid containing “stabilized” cells. Urine is a naturally occurring bodily fluid. As evidenced by the specification, urine from all individuals contains cells ([0002] of PG Pub). The specification does not define the term “stabilized”. Therefore it is indistinguishable from a naturally occurring cell found in urine. Claims 1 and 36 do not recite any concentration or ratios of components. It is noted claim 1 recites a pH of 4.5-5.2. Claim 36 does not recite a pH. The specification does not indicate all of the possible compositions encompassed by the claims have a markedly different characteristic when combined to produce a composition with the claimed pH. Examiner notes Table 3 of the specification indicates combining a naturally occurring sugar, alkanol, chelating agent and boric acid without a buffering agent produces a composition with a pH of 5.0, which reads on the claim (see “Chem F w/o buffer”). Therefore the pH recited in claim 1 does not result in something significantly more than a mixture of the judicial exceptions. Prong Two: Do the claims recite additional elements that integrate the judicial exception into a practical application? No. The claims are directed to a product (i.e. a composition) and not a method of administration to a subject. Question 2B: Do the claims recite any additional elements that amount to significantly more than the judicial exception? Are there any additional elements recited in the claim beyond the exception identified above? Yes. (b) Do the additional elements, taken individually and as a combination result in significantly more? No. Regarding claim 1: The claim recites a pH from 4.5 to 5.2. The specification does not indicate the pH results in a markedly different characteristic (including a synergistic effect) when the claimed ingredients are combined. As set forth above, Table 3 of the specification indicates combining naturally occurring sugar, alkanol, chelating agent and boric acid without a buffering agent produces a composition with a pH of 5.0, which reads on the claim (see “Chem F w/o buffer). Therefore the recited pH does not result in something significantly more than the judicial exceptions. Regarding claim 2: Glucose, fructose, mannose and galactose are known, naturally occurring sugars (judicial exceptions). Rgearding claim 5: a disaccharide (e.g., sucrose) is a judicial exception. Regarding claim 8: ethanol is naturally occurring alkanol (a judicial exception). Regarding claims 14-16: The claims further limit the amounts of sugar, buffer, boric acid and chelating agent. The specification does not indicate combining the claimed ingredients in the claimed ranges results in something significantly more than the recited judicial exceptions. Regarding claims 17-18: The claims recite the intended use of the product recited in claim 1. The intended use does not result in significantly more than the judicial exceptions recited in claim 1. Regarding claim 35: The claim further limits the bodily fluid preserved by the composition of claim 1. This is an intended use which does not result in significantly more than the judicial exceptions recited in claim 1. Regarding claim 37: Glucose, fructose, mannose and galactose are naturally occurring sugars (judicial exceptions). Regarding claim 40: Trehalose, sucrose and lactose are naturally occurring sugars (judicial exceptions). Regarding claim 43: Ethanol is naturally occurring alkanol (a judicial exception). Regarding claim 49: The claim further limits the amount of sugar, buffer, boric acid and chelating agent. The specification does not indicate combining the claimed ingredients in the claimed ranges results in something significantly more than the recited judicial exceptions. Regarding claim 50: Urine and saliva are naturally occurring substance produced by the huma body. These limitations read on judicial exceptions. Regarding claim 52: Nucleic acids, extracellular vesicles and microorganisms are all naturally occurring judicial exceptions. A stabilized nucleic acid is indistinguishable from naturally occurring DNA. A stabilized extracellular vesicle is indistinguishable from a naturally occurring exosome. A stabilized microorganism is indistinguishable from naturally occurring flora found in urine. Therefore, claims 1-2, 5, 8, 14-18, 35-37, 40, 43, 49-50 and 52 are not eligible subject matter under 35 USC 101. APPLICANT’S ARGUMENTS The arguments made in the response filed on 26 June 2026 are acknowledged. Argument 1: The arguments state the specification demonstrates the specific combination of components recited in claim 1, at a pH of 4.5 to 5.2, produces a functional result that none of the individual components achieves alone. The Applicant states in Example 4, the inventors systematically removed individual components from the complete composition ("Chemistry F") and tested the effect on cell-free DNA preservation in urine after 7 days at room temperature. Pointing to [0126] of the specification, the arguments state removal of either ethanol, buffer salt (e.g. sodium acetate), sugar, ethanol plus sugar, and ethanol plus (buffer) salt, as well as elevated pH (≥ 5.5) made the Chemistry F composition less effective in preserving cell-free DNA content as indicated by a decrease in ACt values. Response to Argument 1: Example 4 discloses the following composition: 1750 mM sodium acetate (a buffering agent/salt), 5% boric acid, 119 mM CDTA (chelating agent), 45% fructose (a monosaccharide) and 1 ml of 95% ethanol/methanol (alkanols) (see Tables 3-4). The example is not commensurate with the scope of claims 1 and 36. The claims do not recite any concentrations or ratios. The claims encompass all possible combinations of monosaccharide/disaccharide, buffering agents, C1-C6 alkanols and chelating agents in combination with boric acid (or its salt). While the specification discloses “ethanol in the present composition can also be substituted with methanol” ([0122]) it does not disclose ethanol can be substituted with all C1-C6 alkanols. The specification does not indicate all classes of ingredients in all amounts produce the effect disclosed in Example 4. While Figure 4A discloses “Chemistry F” at a pH of 4.7 has a different ACt value relative to pH 5.5, 6.5, 7.5 and 8.5, the specification does not demonstrate criticality for the claimed range of 4.5-5.2. While the specification discloses removal of either ethanol, sodium acetate, sugar, ethanol plus sugar, and ethanol plus salt, as well as elevated pH 5.5 made the Chemistry F composition “less effective” in preserving cell-free DNA content, it does not disclose a markedly different characteristic (a synergistic effect) when all classes of ingredients recited in the bases claims are combined in all amounts. The arguments are not persuasive. Argument 2: The arguments state removal of any single component materially diminishes the composition's effectiveness, and the claimed pH range is itself critical - raising the pH above 5.2 also reduced effectiveness Response to Argument 2: The Applicant has not provided evidenced of a markedly different characteristic (i.e. a synergistic effect) when the claimed components are combined as recited in claims 1 and 36. A reduced effect is not evidence of a markedly different effect. As set forth above, Example 4 tests “Composition F” at pH 4.7. The Applicant has not demonstrated all pH values within the claimed range are critical. The arguments are not persuasive. 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 36-37, 40, 43, 49-50 and 52 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 36 and 52 recite “stabilized” cells, nucleic acids, extracellular vesicles and microorganisms. The specification does not explicitly define “stabilized”. The specification discloses the composition maintains the stability of cells, nucleic acids, extracellular vesicles, and/or microorganisms for at least 7 days, at least 14 days ([0015] [0058]). Therefore “stabilized” is broadly interpreted to refer to a degree of stability over time. The term “stabilized” in claim 36 and 52 is a relative term which renders the claim indefinite. The term “stabilized” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.. Claims 1-2, 5, 8, 14, 17-18 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer et al. (previously cited; Biological Specimen Collection and Transport System and Method of Use. US20140193804A1) in view of Porter et al. (previously cited; Boric Acid Preservation of Urines Samples. British Medical Journal 1969, 2, 353-355), Daum et al. (previously cited; Multipurpose Compositions for Collecting and Transporting Biological Material. US20210079450A1 (with benefit of Provisional Application 62/901,342, filed on Sep. 17 , 2019, Provisional Application 62/965,380 , filed on Jan. 24 , 2020) and Jackson et al (Methods and devices for storing or stabilizing molecules. US20190144919). Fischer teaches an aqueous composition for collection, transport, storage and preservation of a biological specimen containing nucleic acid (Abstract; [0004] [0012] [0014]). The specimen can be urine ([0110]). The composition comprises one or more chelators ([0018]) one or more buffers ([0024]) and one or more alkanols ([0026]). The composition can optionally include trehalose (a disaccharide) ([0026]). Fischer teaches one or more preferred buffers is desirable to control the pH of the formulations, since it has been found that nucleic acid extraction is optimal in a pH range of about 5 to 7 ([0025]). The deficiencies of Fischer are as follows: The art teaches a disaccharide (trehalose), but does not do so with sufficient specificity to anticipate the claim. The art does not explicitly teach the claimed pH range. The art does not teach boric acid. Porter et al. teach adding boric acid to preserve urine during transport (page 353, right column, second paragraph). Porter teaches 1.8% is the optimal concentration (see Discussion, first paragraph, page 4). Daum et al. teach a compositions for collecting, transporting, and storing biological materials (Abstract). Daum teaches urine is a biological material ([0019]). The art teaches the following sugars: a saccharide monomer (a monosaccharide), a disaccharide, sucrose (a disaccharide), fructose (a monosaccharide), glucose (a monosaccharide), dextrose (a monosaccharide, trehalose (a disaccharide), galactose (a monosaccharide), ribose (a monosaccharide), deoxyribose (a monosaccharide), maltose (a disaccharide), lactose (a disaccharide) or a combination thereof ([0009]). Daum also teaches one or more chelators ([0010]) and buffers (see claim 1 of Daum and [0009]). Jackson et al. teach a method of storing and stabilizing proteins and nucleic acid in serum, plasma and urine from a subject (Abstract; ([0054] [0088] [0125]). The art teaches a buffer that generates a pH between about 3 and about 6 upon ([0103][0111]). Jackson also teaches a buffer that stabilizes the sample ([0103]) and a chelating agent ([0110]). It would have been obvious to add boric acid to Fischer’s composition. Fischer teaches a composition for preserving a bodily fluid and Porter teaches boric acid can be used to preserve a bodily fluid. One would have been motivated to use boric acid to preserve urine. One would have had a reasonable expectation of success since Porter teaches boric acid can preserve urine. One would have expected similar results since both references teach compositions for preserving a bodily fluid from a subject during collection and transport. It would have been obvious to use a sugar in the composition taught by Fischer. One would have been motivated to do so since Daum teaches adding sugars to compositions for stabilizing bodily fluids. One would have had a reasonable expectation of success since Daum teaches sugar can be added to a composition comprising a buffer, a chelating agent and alkanol. One would have expected similar results since both references are directed to compositions for preserving bodily fluids. It would have been obvious to optimize the pH of the composition taught by Fischer. Fischer teaches a composition for preserving a bodily fluid from which nucleic acid will be isolated. One would have been motivated to lower the pH since Fischer teaches a composition for stabilizing a sample comprising a nucleic acid and Jackson teaches a composition with a pH between 3 and about 6 can be used to stabilize a nucleic acid. One would have had a reasonable expectation of success since Fischer teaches nucleic acid can be isolated at a pH of 5 and Jackson teaches nucleic acids can be stabilized with a pH between 3 and 6. See MPEP 2133.03 and MPEP 2144.05 (A. Optimization Within Prior Art Conditions or Through Routine Experimentation). Therefore claim 1 is rendered obvious. Daum teaches a saccharide monomer (a monosaccharide; supra). Therefore claim 2 is included in this rejection. Fischer teaches trehalose (supra). Therefore claim 5 is included in this rejection. Fischer teaches methanol and ethanol ([0026]). Therefore claim 8 is included in this rejection. Regarding claim 14: Fischer teaches 1 mM to about 1 M buffer ([0024]). Daum teaches total sugar concentration is from about 2% to about 10% ([0024]). Fischer teaches about 1% to about 25% alkanol ([0026]). Porter teaches 1.8% boric acid. Fischer teaches 10 mM to 30 mM of a chelator ([0035]). Because the specification does not define the term “about” the ranges taught by the prior art are interpreted to read on the limitations recited in claim 14. Therefore claim 14 is rendered obvious. Claims 17-18 are directed to the intended use of the composition recited in claim 1. Because the claimed composition is rendered obvious, it would be suitable to stabilize the components recited in the claims. Therefore claims 17-18 are included in this rejection. Claim 35 is directed to the intended use of the composition recited in claim 1. Because the claimed composition is rendered obvious, it would be suitable to stabilize urine or saliva. Fischer teaches urine and saliva can be preserved (supra). Therefore claim 35 is included in this rejection. Therefore Applicant’s Invention is rendered obvious as claimed. Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer in view of Porter, Daum and Jackson as applied to claim 1 above, and further in view of Hunt et al. (previously cited; A Study of Chelating Agents and Metal Chelates In Nonaqueous Solvents. Oklahoma State University. 1966, pages 1-66). Claim 1 is rejected on the grounds set forth above. The teachings of Fischer, Porter, Daum and Jackson are reiterated as set forth above. Fischer teaches chelators including EDTA (supra; [0022]). Fischer teaches 1 mM to about 1 M buffer ([0024]). Daum teaches total sugar concentration is from about 2% to about 10% ([0024]). Daum teaches fructose, glucose and sucrose. Fischer teaches about 1% to about 25% alkanol ([0026]). Porter teaches 1.8% boric acid. Fischer teaches 10 mM to 30 mM of a chelator ([0035]). Fischer teaches ethanol and methanol. Jackson teaches 1000 mM sodium acetate ([0295]). Because the specification does not define the term “about” the ranges taught by the prior art are interpreted to read on the limitations recited in claims 15 and 16. The art does not teach CDTA as a chelator. Hunt teaches CDTA is an analogue of EDTA. Metal chelates of CDTA are more stable than EDTA (page 6, last paragraph). CDTA can be easily prepared in methanol (an aqueous alkanol (page 34, last paragraph). It would have been obvious to use CDTA as a chelating in the composition taught by Fischer. Fischer teaches the use of chelating agents including EDTA and Hunt teaches CDTA is an analogue of EDTA. One would have been motivated to use CDTA since Hunt teaches it is more stable than EDTA. One would have had a reasonable expectation of success since Fischer teaches an alkanol and Hunt teaches CDTA can dissolve in an alkanol. One would have expected similar results since both references are directed to chelating agents. Therefore claims 15-16 are included in this rejection. Therefore Applicant’s invention is rendered obvious as claimed. APPLICANT’S ARGUMENTS The arguments made in the response filed on 26 June 2026 are acknowledged. Argument 1: The Applicant argues Jackson teaches buffer impregnated on a support matrix with a water content of less than 2%. The Applicant argues Fischer teaches exemplary pH of 6.5-6.7. The Applicant argues Daum teaches a preferred pH of 6.5 to 7.5 (paragraphs [0021] [0026]). Therefore the Applicant argues the claimed pH is not obvious. Response to Argument 1: Fischer teaches one or more preferred buffers is desirable to control the pH of the formulations, since it has been found that nucleic acid extraction is “optimal in a pH range of about 5 to 7”. Therefore Foster teaches a range that overlaps with the claimed pH range. Jackson teaches a matrix for stabilizing nucleic acid ([0100]). The art teaches using the buffer to stabilize sample preparation reagents and sample components ([0103]). The buffer that generates a pH in a range from about 3 to about 6 when the matrix is dry ([0103]) and a pH between about 3 and about 6 upon hydration ([0111]). Jackson is relied upon because it teaches pH lower than “about 5” can be used to extract nucleic acid from a biological sample. Therefore the arguments are not persuasive. Argument 2: The Applicant argues there is no reason to use boric acid in Fischer’s composition. The Applicant argues Porter is directed to a different issue: preventing bacterial growth so that bacteriological colony counts remain accurate during transit. The arguments state Example 8 of Fischer is directed to "Killing of MRSA (ATCC33592) in Primestore Solution." Paragraph [0151] of Fischer indicates that this example illustrates the effectiveness of the PrimeStore Solution (ver. 2.2) in killing a potential bacterial contaminant. In view of this, boric acid serves no useful purpose in the compositions of Fischer, and as such there is no motivation to add this component to Fischer's composition. Response to Argument 2: Fischer teaches a composition for preserving a bodily fluid. Porter teaches boric acid can be used to preserve a bodily fluid. One would have been motivated to use boric acid to preserve urine. The rejections under 35 USC 103 above are consistent with case law. Applicants are referred to In re Kerkoven (205 USPQ 1069) in which it was shown to be prima facia obvious to combine two compositions, each of which is taught by the prior art to be used for that very same purpose. Therefore, then, barring unexpected results, one would reasonably expect enhanced activity to be observed by combining the compositions taught by Fischer and Daum for preserving urine. Fischer teaches a composition for transport and preservation of urine. Porter uses boric acid to preserve urine during transport. Therefore the references are directed to the same issue. The argument is not persuasive. The arguments directed to the Primestore Solution taught by Foster are acknowledged. The Example cited by the Applicant is not a biological fluid. Foster uses an isolated, deposited strain of Staphylococcus aureus (MRSA) (ATCC33592) to analyze the bactericidal effect of Primestore Solution. Foster is not limited to in vitro killing assays. Foster teaches a solution which can be used for transport and preservation of urine. The argument is not persuasive. Argument 3: The Applicant argues the references are not related. Fischer teaches a composition for transport and preservation of urine. Porter uses boric acid to preserve urine during transport. Daum et al. teach a compositions for collecting, transporting, and storing urine. Jackson et al. teach a method of storing and stabilizing proteins and nucleic acids present in urine. Therefore the references are all directed to compositions for storing and preserving urine. The argument is not persuasive. Claims 36-37, 40, 43, 49-50 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Hogan et al. (Matrices and media for storage and stabilization of biomolecules. US20120308987A1) in view of Gaeta et al. (Nucleic acid preservation solution and methods of manufacture and use. US20190062806A1). Hogan teaches compositions for biomolecule storage in the dry state and in solution (Abstract). Hogan teaches cells are biomolecules ([0154]). Hogan teaches a boric acid or a corresponding salt of boric acid ([0042]).The art teaches chelators as small molecule stabilizers ([0051]). Hogan teaches a monosaccharide or a disaccharide as plasticizers ([0059]). Hogan teaches the matrix is contacted with a buffer ([0163]). Hogan does not teach alkanols. Gaeta teaches nucleic acid preserving compositions (Abstract). The art teaches a biological sample comprising cells ([0026]). Compositions include a buffering agent, a chelating agent, an alcohol and an acid (Abstract). Gaeta teaches ethanol, methanol or propanol (C1-C3 alkanols; [0070]). Alcohols are bactericidal/antimicrobial agents ([0013] [0091]). Gaeta also teaches boric acid ([0076]), a chelating agent and a buffering agent ([0096]). It would have been obvious to combine the teachings of the prior art by using alkanols in Hogan’s storage composition. Gaeta teaches the alkanols are antimicrobials. One would have been motivated to add the alkanols to provide an antimicrobial to the biological sample. One would have had a reasonable expectation of success since Gaeta teaches the alkanols can be used in a composition for preserving a sample. One would have expected similar results since Hogan and Gaeta are both directed to methods of stabilizing a biological sample. Because a composition comprising the claimed components is rendered obvious, a biological fluid comprising cells in the composition are stabilized. Therefore claim 36 is rendered obvious. Hogan teaches a monosaccharide (supra). Claim 37 is included in this rejection. Hogan teaches disaccharides (supra). Claim 40 is included in this rejection. Hogan teaches EDTA ([0051]). Therefore claim 43 is included in this rejection. Regarding claim 49: Hogan teaches monosaccharides and disaccharides are plasticizers. Hogan teaches the plasticizer is present at a concentration of about 0.01% to about 10% ([0064]). Hogan teaches boric acid and borate, inorganic compounds, have a concentration of about 5 mM to about 500 mM ([0099]). Hogan teaches the metal chelators of the foregoing compositions (e.g., EDTA, EGTA) have a concentration of about 0.01 mM to about 50 mM ([0100]). Regarding a buffer agent: Hogan teaches citrate in a medium a concentration of about 0.01 mM to about 200 mM ([0100]). Gaeta teaches 5-25% alcohol ([0091]).Because the specification does not define the term “about” the ranges taught by the prior art are interpreted to read on the limitations recited in claim 49. Claim 49 is included in this rejection. Hogan teaches urine ([0072]). Claim 50 is included in this rejection. Hogan teaches the composition can be used to store nucleic acids (see [0154]). Claim 52 is included in this rejection. Therefore Applicant’s Invention is rendered obvious as claimed. 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 date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. 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 APIR 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. /NATALIE M MOSS/ Examiner, Art Unit 1653 /SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Read full office action

Prosecution Timeline

Sep 30, 2022
Application Filed
Aug 14, 2024
Response after Non-Final Action
Mar 26, 2026
Non-Final Rejection mailed — §101, §103, §112
Jun 26, 2026
Response Filed
Sep 11, 2026
Final Rejection mailed — §101, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
31%
Grant Probability
48%
With Interview (+17.1%)
3y 10m (~0m remaining)
Median Time to Grant
Moderate
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