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 .
Claim Status
Applicant’s submission filed 08/27/2025 has been received and entered. Claims 2, 3, 5, 6, 8 and 13 have been cancelled. Claims 1, 4, 7 and 10-12 have been amended. Claims 4-5 and 15-26 were withdrawn as being directed to non-elected inventions. In instant submission, claim 4 is amended and no longer withdrawn in view of amended claim 1. Accordingly, claims 1, 4, 7, 9-12 and 14 are pending and under current examination.
Status of Prior Rejection/Response to Arguments
The rejection of claims 1-3, 9, 11, 13 and 14 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Grolz, as evidenced by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Agency for Toxic Substances and Disease Registry, Kunitomi et al. and Shifrin et al. is withdrawn:
The cancellation of claims 2, 3 and 13 renders the rejection thereto moot.
Regarding claims 1, 9, 11 and 14, Applicant’s amendment to claim 1 adds the limitations “the cell-membrane-permeable compound is ethylene glycol, propylene glycol, glycerin, dimethyl sulfoxide, acetamide, 1,3-propanediol or butylene glycol” (previous claim 3); “the cell-membrane-impermeable compound is polyvinylpyrrolidone, polyethylene glycol, polyvinyl alcohol, a polysaccharide, a derivative of a polysaccharide, a sugar alcohol or Ficoll, wherein the derivative of a polysaccharide is hydroxypropyl cellulose”; and “the preservative solution contains a formaldehyde donor compound, wherein the formaldehyde donor compound is DMDM hydantoin or 1-hydroxymethyl-5,5- dimethylhydantoin”. Grolz does not teach the limitation of the preservative solution contains a formaldehyde donor compound. The rejection is withdrawn.
The rejection of claims 1-3, 6-11 and 13-14 under 35 U.S.C. 102(a)(1) over Akiyama et al., as evidenced by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Agency for Toxic Substances and Disease Registry, Kunitomi et al. and Shifrin et al. is withdrawn:
The cancellation of claims 2, 3 and 13 renders the rejection thereto moot.
Regarding claims 1, 9, 11 and 14, Applicant amends claim 1 to limit the storage container has a first configuration and a second configuration, asserts that Akiyama never teaches an example using the cell-membrane-permeable compound ethylene glycol and the cell-membrane-impermeable compound PEG (in the same solution)(see Remarks, p11). In addition, the use of ethylene glycol leads to undesirable results (reduced stability, decreased cancer cell recovery rate), therefore teaches away from the use of ethylene glycol in its preservation solution (Remarks, p11-12).
Applicant’s argument is found persuasive. Specifically, the amended claim 1 requires the preservative solution comprising a cell-membrane-permeable compound that has a molecular weight of 100 or less and cannot be frozen at 00C (i.e., ethylene glycol) and a cell-membrane-impermeable compound having a molecular weight of 300 or more (i.e., PEG). Akiyama does not teach a working example wherein the preservative solution comprising both of them. Therefore the rejection is withdrawn.
The rejection of claims 1-3, 6-14 are rejected under 35 U.S.C. 103 over Akiyama et al., as evidenced by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Agency for Toxic Substances and Disease Registry, Kunitomi et al. and Shifrin et al., further in view of Parpart et al. is withdrawn:
The cancellation of claims 2, 3 and 13 renders the rejection thereto moot.
Regarding claims 1, 9, 11 and 14, Applicant amends claim 1 to limit the storage container has a first configuration and a second configuration, asserts that amended independent claim 1 is not taught by or obvious in view of Akiyama. Akiyama never teaches an example using the cell-membrane-permeable compound ethylene glycol and the cell-membrane-impermeable compound PEG (in the same solution)(see Remarks, p11). In addition, the use of ethylene glycol leads to undesirable results (reduced stability, decreased cancer cell recovery rate), therefore teaches away from the use of ethylene glycol in its preservation solution (Remarks, p11-12). Parpart fails to remedy the deficiencies of Akiyama with respect to independent claim 1 (Remarks, p13).
Applicant’s argument is found persuasive. Specifically, the amended claim 1 requires the preservative solution comprising a cell-membrane-permeable compound that has a molecular weight of 100 or less and cannot be frozen at 0°C (i.e., ethylene glycol) and a cell-membrane-impermeable compound having a molecular weight of 300 or more (i.e., PEG). Akiyama does not teach a working example wherein the preservative solution comprising both of them. Moreover, an ordinary skill in the art would not be motivated to use ethylene glycol for cell preservation since it leads to a low cell recovery rate. The rejection is withdrawn.
New ground of rejection is necessitated by Applicant’s amendment.
New claim rejections
Claim Rejections - 35 USC § 112(b)
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, 4, 7, 9-12 and 14 are newly 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. The rejection is necessitated by Applicant’s amendment.
Claim 1 recites “a first configuration” and “a second configuration” renders instant claim indefinite. There is no definition of “configuration” provided in the claim or the specification. According to Merriam-Webster dictionary, the term “configuration” means “something (such as a figure, contour, pattern, or apparatus) that results from a particular arrangement of parts or components”. In instant case, the first configuration of the storage container demonstrates the parts/components of the storage container, which comprises: 1) a container main body, and 2) a preservative solution that contains a cell-membrane-permeable compound has a molecular weight of 100 or less and cannot be frozen at 0°C in the container main body; and the second configuration demonstrates another (set of) the parts/components of the storage container, which comprises: 1) a container main body, and 2) a preservative solution which contains a cell-membrane-impermeable compound that having a molecular weight of 300 or more in the container main body. Each configuration independently limits a storage container. When the claim requires the storage container has both the first and second configuration, it is not clear whether the storage container has both of the configurations but only display one of the configurations (i.e., the preservative solution comprises a cell-membrane-permeable compound or a cell-membrane-impermeable compound), or the storage container has the limitations in both configurations at the same time (i.e., the preservative solution comprises both cell-membrane-permeable and cell-membrane-impermeable compounds). Therefore the scope of the claim is not clear.
In addition, claim 1 recites a cell-membrane-permeable compound that has a molecular weight of 100 or less and cannot be frozen at 0°C. Claim 1 further recites “wherein he cell-membrane-permeable compound is ethylene glycol, propylene glycol, glycerin, dimethyl sulfoxide, acetamide, 1,3-propanediol or butylene glycol”. However, the melting point of Dimethyl sulfoxide (DMSO) is 18-19°C, the melting point of glycerin is 18-20 °C, and the melting point of Acetamide is 79 to 81 °C, they do not meet the limitation of “cannot be frozen at 0°C”.Therefore the limitations lead to an indefinite scope of instant claim.
Claims 4, 7, 9-12 and 14 depend from claim 1, and thus inherit the deficiency and are rejected on the same basis.
Claim Rejections - 35 USC § 112(d)
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 7 and 9 are newly 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. The rejection is necessitated by Applicant’s amendment.
Claims 7 recites the preparation of solution Y’ and Y, claim 9 recites the preparation of a mixed solution Z, they do not further limit the storage container of claim 1, which is directed to a storage container comprising a container main body and a preservative solution contained in the container main body. The preparation of the solutions does not further limit the structure/component of the storage container since the storage container is not required to have a cell-containing solution.
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 Interpretation
Instant application is directed to a storage container (a product). Claim 1 recites “the storage container being provided with a container main body and a preservative solution contained in the container main body, wherein the storage container has a first configuration such that the preservative solution contains a cell-membrane-permeable compound that has a molecular weight of 100 or less and cannot be frozen at 0°C” and “the storage container has a second configuration such that the preservative solution contains a cell-membrane-impermeable compound having a molecular weight of 300 or more”, as well as the species of the cell-membrane-permeable compound, the cell-membrane-impermeable compound and the formaldehyde donor compound further limits the storage container. However, the recitation “(a storage container) for cell-containing solutions, which is used for storing a predetermined amount of a cell-containing solution” is considered as an intended use. The purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02.
In addition, the claim 1 recites “when a mixed solution X is prepared by collecting the predetermined amount of the cell-containing solution in the storage container for cell-containing solutions and mixing the cell-containing solution with the preservative solution, the content of the cell-membrane-permeable compound in the mixed solution X is 1 vol% or more and 5 vol% or less” and “when a mixed solution X is prepared by collecting the predetermined amount of the cell- containing solution in the storage container for cell-containing solutions and mixing the cell- containing solution with the preservative solution, the content of the cell-membrane- impermeable compound in the mixed solution X is 0.5 µmol/L or more and 5 µmol/L or less” does not further limit the storage container since the storage container is not required to have a cell-containing solution, also a cell-containing solution with any amount/volume can be added in the storage container to achieve said concentration of the cell-membrane-permeable compound and cell-membrane-impermeable compound as recited in instant claim.
Based on the same reason stated above, claim 7 recites the preparation method of solution Y and the content of formaldehyde in the mixed solution Y, claim 9 recites the preparation method of solution Z and the osmotic pressure in the mixed solution Z, claims 11 and 12 recites the content of EDTA and glycine in the mixed solution are not considered as further limitations to the storage container.
Moreover, claim 1 and the dependent claims recite “a storage container for cell-containing solution”, herein a storage container is interpreted to satisfy either short term or long-term storage of cell-containing solution (e.g., a blood collection device for short term storage), since the claims do not indicate any specific time frame for said storage.
As stated above, claim 1 is indefinite. In the interest of compact prosecution, claim 1 is interpreted that the preservative solution comprises both a cell-membrane-permeable compound and a cell-membrane-impermeable compound. In addition, the compounds glycerin, dimethyl sulfoxide, acetamide are excluded from the species of the cell-membrane-permeable compounds in claim 1 as they do not meet the limitation “cannot be frozen at 0°C”.
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.
(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.
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, 4, 7, 9, 11, 12 and 14 are newly rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hunsley et al. (WO 2018/145005 A1, published in 2018, cited in IDS), as evidenced by Kunitomi et al. (EP2641966 A1, 2013, cited in IDS), U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Agency for Toxic Substances and Disease Registry (Hereinafter “Registry”, 2010) and Car (Springer, Berlin, Heidelberg, published in 2014). The rejection is necessitated by Applicant’s amendment.
Hunsley et al. teach a blood collection sample tube including a thermoplastic polymeric material having a moisture barrier and low moisture absorption rate, optical transparency to enable viewing a sample within the tube and chemical resistance; and optionally a transparent silicon-containing coating on a majority of the side wall of the tube; and an elastomeric stopper. Prior to collecting a blood sample, the hollow chamber of the tube is in an evacuated condition relative to an ambient pressure, and the hollow chamber is partially filled with a reagent in an initial state, and the reagent is capable of retaining its initial state for a period of at least one month over a temperature range of about 2 °C to about 30 °C (Abstract).
Regarding claim 1, Hunsley et al. teach an improved polymeric tube for blood sample collection, storage, transport and analysis (parag 0005). Prior to collecting the blood sample, the hollow chamber of the tube is in an evacuated condition relative to an ambient pressure, and the hollow chamber is at least partially filled with a reagent in an initial state selected from a solid, a liquid, or a gel, the reagent including an optional anticoagulant, and a preservative composition adapted for stabilizing blood cells of the blood sample for enabling isolation of a nucleic acid or a rare cell/material circulating in the blood sample (parag 0005). This teaching reads on a storage container (herein a polymeric tube for blood sample) being provided with a container main body and a preservative solution contained in the container main body, as recited in instant claim. Hunsley et al. teach the reagents may include one or more cell permeabilizing agents. The one or more cell permeabilizing agents may be selected from the group consisting of DMSO (dimethyl sulfoxide), ethylene glycol … saponin, SDS (sodium dodecyl sulfate) and combinations thereof (parag 00100). This teaching reads on a cell-membrane-permeable compound that has a molecular weight of 100 or less and cannot be frozen at 0°C (i.e., ethylene glycol). Hunsley et al. teach the reagents described may also include additional components, including one or more of the following: Doxycycline, Polyethylene Glycol… Polyethylene Oxide… AEBSF, Alpha-2 Macroglobulin, or combinations thereof (parag 0099). Herein polyethylene glycol (or Polyethylene Oxide) is a cell-membrane-impermeable compound, which is evidenced by Kunitomi et al.’s teaching that the cell membrane non-permeable substance is one or more selected from the group consisting of sodium chloride… sugar alcohols, Ficoll, polyethylene glycol (see parag 0034). This teaching reads on a cell-membrane-impermeable compound (i.e., Polyethylene Glycol or Polyethylene Oxide) as recited in instant claim. Hunsley et al. teach the reagent may include one or more preservative agents. The preservative may be selected from the group consisting of formaldehyde, diazolidinyl urea (DU)… DMDM hydantoin… biocides, a water-soluble zinc salt and any combination thereof (parag 00105). This teaching reads on the preservative solution contains a formaldehyde donor compound DMDM hydantoin. Regarding the molecular weight of ethylene glycol (EG), Registry provides evidence that the molecular weight of ethylene glycol is 62.07, and the melting point is -12.69 °C (p177, table 4-2). Regarding the molecular weight of Polyethylene Glycol PEG or Polyethylene Oxide (PEO), Car provides evidence that Polyethylene oxide (PEO) has two chemically synonymous names: poly(ethylene glycol) (PEG) and poly(oxyethylene) (POE). poly(ethylene glycol (PEG) has tended to refer to oligomers and polymers with a molecular weight below 20,000 g/mol, PEO to polymers with a molecular weight above 20,000 g/mol (p1, left column), therefore PEO is the PEG with a high molecular weight (>20,000 g/mol), reads on the limitation of having a molecular weight of 300 or more in instant claim. In sum, Hunsley et al. teach all the limitations of the storage container as recited in instant claim, therefore anticipates instant claim.
Regarding claim 4, following the discussion above, Hunsley et al. teach the reagents comprising PEG and PEO (see parag 0034), wherein the molecular weight of PEO is PEG with a molecular weight above 20,000 g/mol, therefore anticipates instant claim.
Regarding claims 7 and 9, as discussed above, instant claims do not further limit claim 1. Hunsley et al. anticipate the claims based on the same reason stated in claim 1.
Regarding claim 11, Hunsley et al. teach the reagent may include anticoagulants such as: EDTA (Ethylene Diamine Tetra acetic acid), and similar such compounds (parag 00101), therefore anticipates instant claim.
Regarding claim 12, Hunsley et al. teach the reagent may include one or more aldehyde reaction agents. The reagent may include an amount of aldehyde reaction agent, which aldehyde reaction agent is selected from one or any combination of tris, glycine, or a derivative (e.g., a salt and/or an ester) of
either or both (parag 00107).
Regarding claim 14, following the discussion above, Hunsley et al. teach a blood collection sample tube (Abstract). Therefore the cell-containing solution is blood.
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 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, 4, 7, 9-12 and 14 are newly rejected under 35 U.S.C. 103 as being unpatentable over Hunsley et al. (WO 2018/145005 A1, published in 2018, cited in IDS), as evidenced by Kunitomi et al. (EP2641966 A1, 2013, cited in IDS), U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Agency for Toxic Substances and Disease Registry (Hereinafter “Registry”, 2010) and Car (Springer, Berlin, Heidelberg, published in 2014), in view of Akiyama et al. (WO 2019230532, published in 2019, cited in IDS). The rejection is necessitated by Applicant’s amendment.
Hunsley et al. teach a blood collection sample tube including a thermoplastic polymeric material having a moisture barrier and low moisture absorption rate, optical transparency to enable viewing a sample within the tube and chemical resistance; and optionally a transparent silicon-containing coating on a majority of the side wall of the tube; and an elastomeric stopper. Prior to collecting a blood sample, the hollow chamber of the tube is in an evacuated condition relative to an ambient pressure, and the hollow chamber is partially filled with a reagent in an initial state, and the reagent is capable of retaining its initial state for a period of at least one month over a temperature range of about 2 °C to about 30 °C (Abstract).
Regarding claim 1, Hunsley et al. teach an improved polymeric tube for blood sample collection, storage, transport and analysis (parag 0005). Prior to collecting the blood sample, the hollow chamber of the tube is in an evacuated condition relative to an ambient pressure, and the hollow chamber is at least partially filled with a reagent in an initial state selected from a solid, a liquid, or a gel, the reagent including an optional anticoagulant, and a preservative composition adapted for stabilizing blood cells of the blood sample for enabling isolation of a nucleic acid or a rare cell/material circulating in the blood sample (parag 0005). This teaching reads on a storage container (herein a polymeric tube for blood sample) being provided with a container main body and a preservative solution contained in the container main body, as recited in instant claim. Hunsley et al. teach the reagents may include one or more cell permeabilizing agents. The one or more cell permeabilizing agents may be selected from the group consisting of DMSO (dimethyl sulfoxide), ethylene glycol … saponin, SDS (sodium dodecyl sulfate) and combinations thereof (parag 00100). This teaching reads on a cell-membrane-permeable compound that has a molecular weight of 100 or less and cannot be frozen at 0°C (i.e., ethylene glycol). Hunsley et al. teach the reagents described may also include additional components, including one or more of the following: Doxycycline, Polyethylene Glycol… Polyethylene Oxide… AEBSF, Alpha-2 Macroglobulin, or combinations thereof (parag 0099). Herein polyethylene glycol (or Polyethylene Oxide) is a cell-membrane-impermeable compound, which is evidenced by Kunitomi et al.’s teaching that the cell membrane non-permeable substance is one or more selected from the group consisting of sodium chloride… sugar alcohols, Ficoll, polyethylene glycol (see parag 0034). This teaching reads on a cell-membrane-impermeable compound (i.e., Polyethylene Glycol or Polyethylene Oxide) as recited in instant claim. Hunsley et al. teach the reagent may include one or more preservative agents. The preservative may be selected from the group consisting of formaldehyde, diazolidinyl urea (DU)… DMDM hydantoin… biocides, a water-soluble zinc salt and any combination thereof (parag 00105). This teaching reads on the preservative solution contains a formaldehyde donor compound DMDM hydantoin. Regarding the molecular weight of ethylene glycol (EG), Registry provides evidence that the molecular weight of ethylene glycol is 62.07, and the melting point is -12.69 °C (p177, table 4-2). Regarding the molecular weight of Polyethylene Glycol PEG or Polyethylene Oxide (PEO), Car provides evidence that Polyethylene oxide (PEO) has two chemically synonymous names: poly(ethylene glycol) (PEG) and poly(oxyethylene) (POE). poly(ethylene glycol (PEG) has tended to refer to oligomers and polymers with a molecular weight below 20,000 g/mol, PEO to polymers with a molecular weight above 20,000 g/mol (p1, left column), therefore PEO is the PEG with a high molecular weight (>20,000 g/mol), reads on the limitation of having a molecular weight of 300 or more in instant claim. In sum, Hunsley et al. teach all the limitations of the storage container as recited in instant claim, therefore anticipates instant claim.
Regarding claim 4, following the discussion above, Hunsley et al. teach the reagents comprising PEG and PEO (see parag 0034), wherein the molecular weight of PEO is PEG with a molecular weight above 20,000 g/mol, therefore anticipates instant claim.
Regarding claims 7 and 9, as discussed above, instant claims do not further limit claim 1. Hunsley et al. anticipate the claims based on the same reason stated in claim 1.
Regarding claim 11, Hunsley et al. teach the reagent may include anticoagulants such as: EDTA (Ethylene Diamine Tetra acetic acid), and similar such compounds (parag 00101), therefore anticipates instant claim.
Regarding claim 12, Hunsley et al. teach the reagent may include one or more aldehyde reaction agents. The reagent may include an amount of aldehyde reaction agent, which aldehyde reaction agent is selected from one or any combination of tris, glycine, or a derivative (e.g., a salt and/or an ester) of
either or both (parag 00107).
Regarding claim 14, following the discussion above, Hunsley et al. teach a blood collection sample tube (Abstract). Therefore the cell-containing solution is blood.
Regarding claim 10, Hunsley et al. do not teach the preservative solution contains an osmotic pressure-controlling agent, and the osmotic pressure-controlling agent is glucose or sodium chloride. However, this was disclosed by Akiyama et al..
Akiyama et al. teach a method for producing a blood sample that can be stored stably. In particular, the invention relates to a method for manufacturing a blood sample that can be stably stored for vibration, temperature changes, and the like from a low temperature at which a blood sample is not frozen, under a room temperature environment (parag 0001).
Regarding claim 10, Akiyama et al. teach using sodium chloride (NaCl) for adjusting osmotic pressures (see parag 0097), and teach that the osmotic pressure of the preservative according to one embodiment of the invention may be adjusted to any value in advance (parag 0019).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hunsley et al.’s blood collection sample tube comprising reagents such as a cell-membrane-impermeable compound PEG, cell-membrane-permeable compound ethylene glycol and a formaldehyde donor compound DMDM hydantoin, and further have sodium chloride (NaCl) for adjusting osmotic pressures of the reagents contained solution as taught by Akiyama et al.. The skilled artisan would have been motivated to use NaCl to adjust the osmotic pressures of the solution to a desired level for further processing of the blood samples (see parag 0019 of Akiyama et al.). There would be a reasonable expectation of success of using NaCl for adjusting osmotic pressures since Akiyama et al. teach an example of using NaCl for adjusting osmotic pressures (see working example 12).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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