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 without traverse of Group I, claims 1, 3-10, and 26 in the reply filed on November 25, 2025 is acknowledged.
Claims 11, 14-18, and 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
It is noted that the phrases “at least one” and “one or more” only require one.
It is noted that the terms “or” and “and/or” (minimally means “or”) provides for alternatives not requirements.
In claim 1, it is noted that “a biological sample”, “an anticoagulant”, “stabilizing components”, and “stabilizer agent” are not specified as being any specific material, substance, chemical, etc.
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 1, 3-10, and 26 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.
As to claim 1, it is unclear how the method is a method of making a biological collection container because the container already exists has been already made as stated in the providing step. There is no step that provides for making the container.
As to claim 1, it is unclear if the container comprises an opening and a cover in the opening because the phrase “for defining an opening configured for receiving a cover” does not required such. The “for…” and “configured for” are directed to intended use.
As to claim , it is unclear if “the one or more stabilizer components” are the same as the prior recited “one or more stabilizing components”. If so consistent terminology should be employed to clearly indicate such.
The terms “substantially constant” and “substantially contemporaneously” in claim 1 are relative terms which renders the claim indefinite. The terms “substantially constant” and “substantially contemporaneously” are not defined by the claim, 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. There is no definition of such terms provided for in the claim. What may be considered as “substantially constant” and “substantially contemporaneously” to one person may not be considered as such to another and vice versa.
Claim 1 recites the limitation "the stabilizer agent" in ii) 1). There is insufficient antecedent basis for this limitation in the claim. It is unclear what is the nexus of such to the “one or more stabilizer components” It is noted that no formulating, reacting, and mixing are recited as steps in the claim. What the coating is intended to/can exhibit and dissolve does not provide for any method steps of making the container.
It is further unclear what “individual” (of what); ingredients” (of what, and what is considered ingredients); and “reaction products” of what is being referenced in the claim because the claim does not clearly provide for such. Furthermore, it is noted that the method does not require any step of storing anything under any conditions nor for at least 90 days nor any dissolving of anything. However, it is unclear what constitutes ambient storage conditions because such is not defined in the claim.
Claim 1 recites the limitation "the presence of a liquid of the biological sample" in ii) 2). There is insufficient antecedent basis for this limitation in the claim.
Furthermore, it is unclear which what biological sample is being referenced by “the biological sample” because a) recites “a biological sample” twice and such are not required to be the same. Furthermore, there no requirement for any biological sample to be employed in any step to make the container. There is no collection of any biological sample nor any of those items listed in the “any present…” clause…white blood cells, cell-free nucleic acids, extracellular vesicles, circulating tumor cells, proteins, metabolomes are required to be present involved in the method of making the container.
The term “stabilization” in claim 1 is a relative term which renders the claim indefinite. The term “stabilization” is not defined by the claim, 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. Although no stabilizing is required to be performed as a step in the method, it is noted that what be considered as “stabilization” to one person may not be considered as such to another and vice versa.
Dependent claims 3-10 and 26 are rejected via dependency upon a rejected claim.
As to claims 3-7, it is unclear what is/are “a starting material ingredient”; “a starting material an ingredient” ; and “starting materials ingredients”. Nothing is required to be started…. It appears if such is/are the same as a stabilizer agent. Thus it is unclear what is meant, required by the “starting material” phrases.
As to claims 3 and 7, it is unclear what in the nexus of “a stabilizer agent” to the prior recited “one or more stabilizing components” and “the stabilizer agent” recited in claim 1 because the claims do not provide for such.
Claim 3 contains the trademark/trade names Nuosept, Quaternium, Bioban, Preventol and Grotan. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe biocides and fungicides and/or chemicals, accordingly, the identification/description is indefinite.
As to claim 7, it is unclear if the phrase “by weight” is intended be required to be part of the claim because such is included in parenthesis.
The term “about” in claim 7 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, 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. There is no indication as to what values other than the exact value recited in the claim is considered as “about” the recited value.
The term “thin” in claim 8 is a relative term which renders the claim indefinite. The term “thin” is not defined by the claim, 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. There is no indication as what values are required to be considered as a “thin film” what may be considered as thin to one person may not be considered as such to another and vice versa. Furthermore, it is unclear over what region of what is being referenced in the claim.
Claim 9 recites the limitation "the step of coating". There is insufficient antecedent basis for this limitation in the claim. No coating step has been previously recited.
Claim 26 recites the limitation "the reaction". There is insufficient antecedent basis for this limitation in the claim. There is no prior reciting of “depositing a reaction”. It is presumed such is intended to refer to the reagent.
Claim Rejections - 35 USC § 102
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, 3-4, and 6-7 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Ryan, US 2010/0167271.
Ryan discloses a method of making a biological sample collection container, comprising:
a) providing a container (10) including a base (14); at least one side wall (16) having a length and that is attached to the base, and including structure for defining an opening (18) configured for receiving a cover (22) and for receiving a biological sample, the at least one side wall defining a chamber having a volume within which a biological sample is received (see paragraphs [0065], [0066], [0092], figure 1 C, claims 12, 18);
b) depositing a reagent comprising an anticoagulant and one or more stabilizing components in a liquid state at least partially along at least one side wall of the container (see paragraph [0092], figure 1 C - "HH" and claim 13);
c) drying the reagent to form a dried coating of the reagent along at least a portion of the at least one side wall (see paragraph [0092] and claim 14), wherein:
i) the coating includes, in a dried state, a formulation that results from mixing the one or more stabilizer components and the anticoagulant (see paragraph [0092]);
ii) the coating is formulated, and applied to be in a form, that:
1) exhibits a substantially constant concentration of the formulation that results from mixing the stabilizer agent and the anticoagulant or individual, and/or ingredients and/or reaction products thereof, after being subjected to ambient storage conditions over a period of at least 90 days (see paragraph [0087]),
2) dissolves in the presence of a liquid phase of the biological sample (see paragraph [0094]) substantially contemporaneously with a collection of the biological sample for causing stabilization of any present white blood cells, cell-free nucleic acids, extracellular vesicles, circulating tumor cells, proteins, metabolomes, or any combination thereof. (see paragraph [0094]).
As to claim 3, the reagent includes, as a starting material ingredient, a stabilizer agent selected from one or any combination of diazolidinyl urea (DU), dimethylol urea, 2-bromo-2-nitropropane-1,3-diol, 5-hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo (3.3.0)octane and 5-hydroxymethyl-l-aza-3,7-dioxabicyclo (3.3.0)octane and 5-hydroxypoly [methyleneoxy]methyl-1-aza-3,7-dioxabicyc1 o (3.3.0)octane, bicyclic oxazolidines (e.g. Nuosept 95), DMDM hydantoin, imidazolidinyl urea (IOU), sodium hydroxymethylglycinate, hexamethylenetetramine chloroallyl chloride (Quaternium-15), biocides (such as Bioban, Prevento! and Grotan), or a watersoluble zinc salt (see paragraph [0092] and claim 16).
As to claim 4, the reagent includes as a starting material an ingredient with an amine functionality (see paragraph [0092] and claim 16).
As to claims 6-7, the reagent includes as a starting material ingredient one or any combination of anticoagulants selected from ethylenediaminetetraacetic acid (EDTA), a sodium citrate or an acid-citrate-dextrose, an oxalate or heparin (see paragraph [0092] and claim 17); and that the reagent includes as starting material ingredients a stabilizer agent and an anticoagulant in a relative proportion (by weight) of 0.1 :5 to about 8:1 (see paragraph [0092] and claim 17).
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.
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.
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryan, US 2010/0167271 as applied above, and further in view of Parthasarathy; Ranjani V. et al., US 20100136554 A1.
Ryan does not specify the reagent includes cyclodextrin or a functionalized derivative thereof as a starting material ingredient.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
Parthasarathy discloses a device and method in which a reagent layer is employed and such layer includes cyclodextrin.
It would have obvious to and within the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention to recognize cyclodextrin may be one of many reagents in a layer as taught by Parthasarathy.
Claim(s) 8-10 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryan, US 2010/0167271 as applied above, and further in view of Chiarin; Renzo et al.; US 2010/0254859.
Ryan does not specify the coating is in the form of a predetermined pattern of microparticles, a continuous thin film over a region.
Chiarin discloses a container a protective film made of PP, PE or copolymers that be over further layers of the tube. Furthermore, anticoagulation volume can be placed in the container over further layers components of the tubes for measuring the coagulation of blood. (See paragraphs 0002, 07, 48-49).
It would have obvious to and within the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention to recognize that a coating layer/film can be provided for on a container of Ryan to provide for measuring coagulation of blood as taught by Chiarin.
As to claim 26, spray-coating is a conventional known coating application technique within the common sense, knowledge and skill of one of ordinary skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Manoussakis, Dimitrios et al.; Dastane; Ajit et al.; Jones; Huw David et al.; Carroll; Richard J. et al.; and McAlister; Gary B. discloses collection containers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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