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 17 February 2026.
ELECTION
Applicants’ election with traverse of Group I (Claims 1-2, 5, 8, 14-18); drawn to an aqueous stabilizing composition) in the reply filed on 17 February 2026 is acknowledged. Claims 35-37, 40, 43, 49-50 have been rejoined upon further consideration. Claims 25-27, 34 and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. The requirement is still deemed proper and is therefore made FINAL.
CLAIMS UNDER EXAMINATION
Claims 1-2, 5, 8, 14-18, 35-37, 40, 43 and 49-50 have been examined on their merits.
PRIORITY
Provisional Application 63/002,123 filed on 30 March 2020, is acknowledged.
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, 17-18, 35-37, 40, 43 and 49-50 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 in the claims that set forth a nature based product is:
An aqueous composition comprising sugar, a buffer, an alkanol, boric acid and a chelating agent (claim 1) and a bodily fluid (claim 36).
The nature based product lacks markedly different characteristics (and thus is a 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 composition reads on a judicial exception. Glucose (a monosaccharide) is a naturally occurring sugar (a judicial exception). As evidenced by the specification, citrate is a buffer (PG Pub [0050]). Citrate is naturally occurring (a judicial exception). Ethanol is a known naturally occurring alkanol (a judicial exception). Boric acid is naturally occurring compound of boron, oxygen and hydrogen which is derived from boron. It is a judicial exception. As evidenced by Mussio et al., polysaccharides are naturally occurring chelating agents (judicial exceptions; see page 4, left column, first paragraph). Claim 36 also recites a bodily fluid. Fluids obtained from a human body are naturally occurring (hence, 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 something significantly more than the recited judicial exceptions.
Regarding claim 2: Glucose, fructose, mannose and galactose are known, naturally occurring sugars (judicial exceptions).
Regarding claim 3: Trehalose, sucrose and lactose are naturally occurring sugars (judicial exceptions).
Regarding claim 8: ethanol is naturally occurring alkanol (a judicial exception).
Regarding claim 14: The claim further limits 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 recites 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.
Therefore, claims 1-2, 5, 8, 14, 17-18, 35-37, 40, 43 and 49-50 are not eligible subject matter under 35 USC 101.
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 14, 15 and 19 are 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.
Regarding claim 14: The claim recites (wt/vol) and (vol/vol). The use of parentheses makes it unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required. All dependent claims are included in this rejection.
Regarding claim 15: The claim recites (wt/vol) and (vol/vol). The use of parentheses makes it unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required. All dependent claims are included in this rejection.
Regarding claim 49: The claim recites (wt/vol) and (vol/vol). The use of parentheses makes it unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required. All dependent claims are included in this rejection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8, 15 and 43 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 recites a combination of buffering agents. The base claim recites “a buffer agent”. A combination of buffers does not further limit a single buffer. Appropriate correction is required.
Regarding claim 15: The claim recites a combination of alkonols. The base claim recites alkanol. A combination of alkonols does not further limit a single alkanol. Appropriate correction is required.
Regarding claim 43: The claim recites a combination of buffers. The base claim recites “a buffering agent”. A combination of buffers does not further limit “a buffer” as recited in the base claim. Appropriate correction is required.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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. (Biological Specimen Collection and Transport System and Method of Use. US20140193804A1) in view of Porter et al. (Boric Acid Preservation of Urines Samples. British Medical Journal 1969, 2, 353-355), Daum et al. 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 a aqueous composition for collection, transport and storage of a biological specimen containing nucleic acid (Abstract; [0004]). Fischer teaches the composition can be used for preservation ([0012] [0014]). The composition comprises one or more chelators ([0018]) one or more buffers ([0024]) one or more alkanols ([0026]). The art teaches composition may optionally include trehalose as an osmolyte ([0026]).
The art also teaches the following:
The inclusion of 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 art teaches the pH of the composition can be about 6 ([0025]). Fischer teaches biological samples include, but are not limited to, whole blood, plasma, serum, urine, tears, vaginal fluids, saliva, semen, lymphatic fluid and cerebrospinal fluid ([0110]). These are bodily fluids.
The deficiencies of Fischer are as follows:
The art teaches trehalose (a disaccharide, sugar), but does not do so with sufficient specificity to anticipate the claim.
The art does not explicitly teach the claimed pH range of 4.5 to 5.2
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 without refrigeration (Abstract). The composition comprises one or more sugars and buffers (see claim 1 of Daum; [0009]).The one or more sugars comprise a saccharide monomer, a disaccharide, an oligosaccharide, sucrose, fructose, glucose, dextrose, trehalose, galactose, ribose, deoxyribose, maltose, lactose, or a combination thereof ([0009]). The art teaches adding one or more chelators ([0010]). Daum teaches biological samples include, but are not limited to, whole blood, plasma, serum, urine, tears, vaginal fluids, saliva, semen, lymphatic fluid and cerebrospinal fluid ([0019]). These are bodily fluids.
Jackson et al. teach a method of storing and stabilizing proteins and nucleic acid in a sample from a subject (Abstract). The sample can be stabilized and stored on a matrix (Abstract). The matrix includes a buffer that stabilizes the sample ([0103]) and a chelating agent ([0110]). The buffer can generate a pH in a range of from about 3 to about 6 ([0103]). The matrix can be configured to provide a pH between about 3 and about 6 upon hydration ([0111]). Samples from a subject include serum, plasma and urine ([0054] [0088] [0125]).
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 when preserving 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 do 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 36-37, 40, 43 and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer et al. in view of Porter et al. and Daum et al.
Regarding independent claim 36: The teachings of Fischer are reiterated. Fischer teaches adding the composition to a bodily fluid (supra).
The deficiencies of Fischer are as follows:
The art teaches trehalose (a disaccharide, sugar), but does not do so with sufficient specificity to anticipate the claim.
The art does not teach boric acid.
The teachings of Daum and Porter as set forth above are reiterated.
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 when preserving 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.
Therefore claim 36 is rendered obvious.
Daum teaches a saccharide monomer (a monosaccharide; supra). Therefore claim 37 is included in this rejection.
Fischer teaches trehalose (supra). Therefore claim 40 is included in this rejection.
Fischer teaches methanol and ethanol ([0026]). Therefore claim 43 is included in this rejection.
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 49. Therefore claim 49 is rendered obvious.
Fischer teaches urine and saliva (supra). Therefore claim 50 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. (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.
Conclusion
No claims are allowed.
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) 270-8439.
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/NATALIE M MOSS/ Examiner, Art Unit 1653