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
Requirement of Restriction filed on 10/31/2025 has been withdrawn in response to an amendment filed on 12/30/2025. All claims are currently being examined.
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.
Claim 1 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: Applicants merely list a series of elements with no relationship between the elements.
Claims 1-2 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. Applicants recite in claim 1 “the biological transport media is borate-free” and claim 2 recites the biological transport media recites a borate. It is unclear what applicants are intending to claim when claim recites the transport media is borate-free and claim 2 recites a borate in the transport media.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “borate”, and the claim 1 also recites “borate-free” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claim(s) 1-9 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Whitney (EP 2430195 B1).
Regarding claim 1, Whitney teaches compositions and methods for biological sample storage comprising a pH adjuster; one or more hydroxyl radical scavengers; a metal chelator; (Refer to paragraphs [0134-0135]) a reducing agent; an inhibitor; (Refer to paragraphs [0011-0012]) a stabilizer; (Refer to paragraph [0019]) an antimicrobial agent (Refer to paragraph [0012]); wherein the biological transport media is borate-free (Refer to 112 rejections above).
Regarding claim 2, the pH adjuster is lithium hydroxide, lithium dodecyl sulfate, lithium chloride, benzylidene rhodanine, sulfosalicylic acid, citric acid, tartaric acid, malic acid, sulfosalicylic acid, sulfoisophthalic acid, oxalic acid, borate, CAPS (3- cyclohexylamino)-1-propanesulfonic acid), CAPSO (3-(cyclohexylamino)-2-hydroxy- 1-propanesulfonic acid), EPPS (4-(2-hydroxyethyl)-1-piperazinepropanesulfonic acid), HEPES (4-(2-hydroxyethyl)piperazine-1-ethanesulfonic acid), MES (2-(N-morpholino)ethanesulfonic acid), MOPS (3-(N-morpholino)propanesulfonic acid), MOPSO (3-morpholino-2- hydroxypropanesulfonic acid), PIPES (1,4-piperazinediethanesulfonic acid), TAPS (N[tris(hydroxymethyl)methyl]-3- aminopropanesulfonic acid), TAPSO (2-hydroxy-3- [tris(hydroxymethyl)methylamino]-1-propanesulfonic acid), TES (N- [tris(hydroxymethyl)methyl]-2-aminoethanesulfonic acid), bicine (N,N-bis(2- hydroxyethyl)glycine), tricine (N- tris(hydroxymethyl)methy|]glycine), tris (tris(hydroxymethyl)aminomethane), bis-tris (2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)- 1,3-propanediol), 5-(4-dimethyl)amino benzylidene rhodanine, or a combination thereof. (Refer to paragraph [0133-0134])
Regarding claim 3, the hydroxyl radical scavenger is mannitol, erythritol, sorbitol, xylitol, azide, cysteine, lithium dodecyl sulfate, dimethylsulfoxide, histidine, salicylic acid, salicylate, monosaccharides, disaccharides, or a combination thereof. (Refer to paragraph [0098])
Regarding claim 4, the inhibitor is aurintricarboxylic acid, boric acid, citric acid, salicylic acid, 1,2-bis(o-aminophenoxy)ethane- N,N,N',N'-tetraacetic acid (BAPTA), diethylene triamine pentaacetic acid (DTPA), ethylenediaminetetraacetic acid (EDTA), ethylene glycol tetraacetic acid (EGTA), glycoletherdiaminetetraacetic acid (GEDTA), N-(2-hydroxyethyl)ethylenediamine-N,N",N- triacetic acid (HEDTA), nitrilotriacetic acid (NTA), 2,2'-bipyridine, o-phenanthroline, triethanolamine, or a combination thereof. (Refer to paragraph [0011-0012])
Regarding claim 5, the metal chelator is boric acid, aurintricarboxylic acid (ATA), borate, citric acid, citrate, salicylic acid, salicylate, 1,2- bis(o-aminophenoxy)ethane- N,N,N',N'-tetraacetic acid (BAPTA), diethylene triamine pentaacetic acid (DTPA), ethylenediaminetetraacetic acid (EDTA), ethylene glycol tetraacetic acid (EGTA), glycoletherdiaminetetraacetic acid (GEDTA), N-(2- hydroxyethyl)ethylenediamine-N,N),N-triacetic acid (HEDTA), nitrilotriacetic acid (NTA), 2,2'- bipyridine, o-phenanthroline, triethanolamine, or a combination thereof. (Refer to paragraphs [0134-0135])
Regarding claim 6, the reducing agent is EDTA, EGTA, o-phenanthroline, dithionite, dithioerythritol, dithiothreitol (DTT), dysteine, 2- mercaptoethanol, mercaptoethylene, bisulfite, sodium metabisulfite, pyrosulfite, pentaerythritol, thioglycolic acid, citrate, urea, uric acid, vitamin C, vitamin E, superoxide dismutases, or a combination thereof. (Refer to paragraphs [0011-0012])
Regarding claim 7, the stabilizer is polyethylene glycol. (Refer to paragraph [0153])
Regarding claim 8, the antimicrobial agent is penicillin, cephalosporin, ampicillin, amoxycillin, aztreonam, clavulanic acid, imipenem, streptomycin, gentamycin, vancomycin, clindamycin, polymyxin, erythromycin, bacitracin, amphotericin, nystatin, rifampicin, tetracycline, chlortetracycline, doxycycline, chloramphenicol, ammolfine, butenafine, naftifine, terbinafine, ketoconazole, fluconazole, elubiol, econazole, econaxole, itraconazole, isoconazole, imidazole, miconazole, sulconazole, clotrimazole, enilconazole, oxiconazole, tioconazole, terconazole, butoconazole, thiabendazole, voriconazole, saperconazole, sertaconazole, fenticonazole, posaconazole, bifonazole, flutrimazole, nystatin, pimaricin, amphotericin B, flucytosine, natamycin, tolnaftate, mafenide, dapsone, caspofungin, actofunicone, griseofulvin, potassium iodide, Gentian Violet, ciclopirox, ciclopirox olamine, haloprogin, silver sulfadiazine, undecylenate, undecylenic acid, undecylenic alkanolamide, Carbol-Fuchsin, nevirapine, delavirdine, efavirenz, saquinavir, ritonavir, indinavir, nelfinavir, amprenavir, zidovudine (AZT), stavudine (d4T), larnivudine (3TC), didanosine (DDI), zalcitabine (ddC), abacavir, acyclovir, penciclovir, valacyclovir, ganciclovir, rutin, tannic acid, Direct Red 80, or a combination thereof. (Refer to paragraph [0002])
Regarding claim 9, the media is a solid or a liquid. (Refer to paragraph [0002])
Regarding claim 17, a sample carrier and the transport media. (Refer to paragraph [0003])
Regarding claim 18, the hydroxyl radical scavenger and/or oxygen radical scavenger is mannitol, erythritol, sorbitol, xylitol, azide, cysteine, lithium dodecyl sulfate, dimethylsulfoxide, histidine, salicylic acid, salicylate, monosaccharides, disaccharides, or a combination thereof. (Refer to paragraph [0098])
Regarding claim 19, the metal chelator is boric acid, aurintricarboxylic acid (ATA), borate, citric acid, citrate, salicylic acid, salicylate, 1,2-bis(o-aminophenoxy)ethane- N,N,N',N'-tetraacetic acid (BAPTA), diethylene triamine pentaacetic acid (DTPA), ethylenediaminetetraacetic acid (EDTA), ethylene glycol tetraacetic acid (EGTA), glycoletherdiaminetetraacetic acid (GEDTA), N-(2- hydroxyethyl)ethylenediamine-N,N',N-triacetic acid (HEDTA), nitrilotriacetic acid (NTA), 2,2'- bipyridine, o-phenanthroline, triethanolamine, or a combination thereof; and wherein the serine protease is Proteinase k. (Refer to paragraphs [0134-0135] and [0136])
Regarding claim 20, the sample carrier is a saliva collection tube, a vial, a collection cup, a corrugated jar, a container jar, a collection tube, an absorbent pouch, and/or a collection tube comprising a swab. (Refer to paragraph [0003])
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) 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whitney.
Refer above for the teachings of Whitney. Regarding claim 10, a serine protease. (Refer to paragraph [0091]) Regarding claim 11, the serine protease is Proteinase k. (Refer to paragraph [0136]) Regarding claims 13-14, adding the biological sample to the biological transport media. (Refer to paragraphs [0002-0003] and [0027]) Regarding claim 15, the biological sample is when a liquid added to the biological transport media and is dried on the biological transport media. (Refer to paragraph [0052-0055])
Whitney fails to teach the media comprises about 1-10% of the pH adjuster, about 15-35% of the one or more hydroxyl radical scavengers, about 5-25% of the metal chelator, about 15-30% of the reducing agent, about 0.1-5% of the inhibitor, about 35-55% of the stabilizer, and about 0.5-10% of the antimicrobial agent.
It would have been obvious to one having ordinary skill in the art to modify the media of Whitney such that 1-10% of the pH adjuster, about 15-35% of the one or more hydroxyl radical scavengers, about 5-25% of the metal chelator, about 15-30% of the reducing agent, about 0.1-5% of the inhibitor, about 35-55% of the stabilizer, and about 0.5-10% of the antimicrobial agent in order to obtain an optimal media result during storage.
Conclusion
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/JYOTI NAGPAUL/Primary Examiner, Art Unit 1798