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 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 7, 13, and 16 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.
Considering Claim 7: Claim 7 recites a concentration of the EDC and NHS, but does not identify in which step of the process the concentration is required. As such, the scope of the claim is indefinite. For the purpose of further examination, the claim is being interpreted as requiring the concentration in the first buffer solution.
Considering Claim 13: Claim 13 recites the limitation "the second precipitate" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of further examination, the claim will be interpreted as depending from claim 12 to provide proper antecedent basis.
Considering Claim 16: Claim 16 recites the limitation "the dye labled polymer preicipate" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of further examination, the claim will be interpreted as depending from claim 12 to provide proper antecedent basis.
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.
Claims 19 and 25 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fong et al. (US Pat. 5,128,419).
Considering Claim 19: Fong et al. teaches a polymer of the formula
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134
108
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Greyscale
where the R is a residue of the fluorescent derivatizing agent providing the structure
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84
56
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, where R5 is hydrogen (3:17-68). Fong et al. teaches the polymer as having a molecular weight of 10 MDa (Example 41).
Fong et al. does not teach the claimed process for preparing the polymer. However, the instant claims are product by process claims. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP § 2113.
Considering Claim 25: Fong et al. teaches the polymer as being an anionic polyacrylamide (Example 33).
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.
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.
Claims 1-5, 7, 8, 11-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Fong et al. (US Pat. 5,128,419) in view of Cristine de Silveira et al. (J. APPL. POLYM. SCI. 2015, 42797, pg. 1-9) and Madison et al. (Ind. Eng. Chem. Res. 2013, 52, 13547−13555).
Considering Claims 1, 5, and 8: Fong et al. teaches a process for labeling a polymer with a dye (2:63-68) comprising a polymer comprising carboxylic acid groups or amide groups/groups convertible to a carboxyl group (4:63-5:8), wherein the dye comprises an amino group (3:36-47), the method comprising mixing the polymer with a buffer solution, and mixing the polymer with a dye to form a dye labeled polymer (Example 33).
Fong et al. does not teach including an activating agent. However, Cristine de Silveira et al. teaches using a combination of N-(3-dimethylaminopropyl)-N’-ethylcarbodiimide and N-hydroxysuccimide to activated a polyacrylamide polymer for reaction with a primary amine (pg. 3). The activator is added to the polymer to prepare an activated polymer prior to the addition of the amine in a two step process. Fong et al. and Cristine de Silveira et al. are analogous art as they are concerned with the same technical difficulty, namely reacting a polyacrylamide polymer with a primary amine. It would have been obvious to a person of ordinary skill in the art to have added the activating agent of Cristine de Silveira et al. to the polymer of Fong et al. prior to the addition of the amine dye, and the motivation to do so would have been, as Cristine de Silveira et al. suggests, the reaction has high efficiency without the need for elevated temperature or organic solvents (Abstract).
Fong et al. does not teach a buffer being used with the amine dye. However, Madison et al. teaches that the carbodiimide assisted reaction between an amine and a carboxylic acid results in the release of protons that will alter the pH of the system absent a buffer (pg. 13548). Further, Madison et al. teaches the ideal pH for the activation is 4.75/about 5 and the ideal pH for the amidation is 7 (pg. 13551). Fong et al. and Madison et al. are analogous art as they are concerned with the same technical difficulty, namely reacting a carboxylic acid with a primary amine dye. It would have been obvious to a person of ordinary skill in the art to have controlled the pH of the two stages of the reaction of Fong et al. through a buffer solution, as Madison et al., and the motivation to do so would have been, as Madison et al. suggests, to keep the pH at the ideal for the reaction.
Considering Claim 2: Fong et al. teaches the polymer as being in a latex/in suspension in an example (Example 41).
Considering Claim 3: Fong et al. teaches the polymer as being an anionic polyacrylamide (Example 33).
Considering Claim 4: Fong et al. teaches the polymer as having a molecular weight of 10 MDa (Example 41).
Considering Claim 7: Fong et al., Cristine de Silveira et al., and Madison et al. collectively do not teach the claimed concentration of EDC and NHS. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05. It would have been obvious to a person of ordinary skill in the art to have optimized the concentration of the activator and the motivation to do so would have been, to optimize the reaction rate between the amine and the polymer.
Considering Claim 11: Fong et al., Cristine de Silveira et al., and Madison et al. do not teach isolating the intermediate prior to amidation. However, as shown by Madison et al., it is known to isolate polymer products. Madison et al. teaches centrifuging the labeled polymer following reaction, followed by decanting the supernant (pg. 13550). It would have been obvious to a person of ordinary skill in the art to have isolated the intermediate product by centrifuging and decantation, and the motivation to do so would have been, to provide an isolated product for later use.
Considering Claims 12-15: Fong et al. does not teach isolating the reacted polymer by centrifuging. However, Madison et al. teaches centrifuging the labeled polymer following reaction, followed by decanting the supernant, washing the precipitate by suspending the precipitate in a washing solvent, centrifuging the precipitate, decanting the wash water, and drying the labeled polymer (pg. 13550). The washing step is repeated until no amine is left in the supernatant. It would have been obvious to a person of ordinary skill in the art to have used the purification steps of Madison et al. in the process of Fong et al., and the motivation to do so would have been, to isolate unreacted amine species from the mixture (pg. 13550).
Considering Claim 18: The Office realizes that all of the claimed effects or physical properties are not positively stated by the reference(s). However, the reference(s) teaches all of the claimed ingredients, in the claimed amounts, and teaches the composition as being made by a substantially similar process. The original specification does not provide any disclosure on how to obtain the claimed properties outside the components of the composition itself. Therefore, the claimed effects and physical properties, i.e. the viscosity would necessarily arise from a composition with all the claimed ingredients in the claimed amounts. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching enabling a person of ordinary skill in the art to obtain the claimed properties with only the claimed ingredients, absent undue experimentation.
Claims 19 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Fong et al. (US Pat. 5,128,419) in view of Cristine de Silveira et al. (J. APPL. POLYM. SCI. 2015, 42797, pg. 1-9) and Madison et al. (Ind. Eng. Chem. Res. 2013, 52, 13547−13555).
Considering Claim 19: Fong et al. teaches a polymer of the formula
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134
108
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Greyscale
where the R is a residue of the fluorescent derivatizing agent providing the structure
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media_image2.png
84
56
media_image2.png
Greyscale
, where R5 is hydrogen (3:17-68). Fong et al. teaches the polymer as having a molecular weight of 10 MDa (Example 41).
Fong et al. teaches a process for labeling a polymer with a dye (2:63-68) comprising a polymer comprising carboxylic acid groups or amide groups/groups convertible to a carboxyl group (4:63-5:8), wherein the dye comprises an amino group (3:36-47), the method comprising mixing the polymer with a buffer solution, and mixing the polymer with a dye to form a dye labeled polymer (Example 33).
Fong et al. does not teach including an activating agent. However, Cristine de Silveira et al. teaches using a combination of N-(3-dimethylaminopropyl)-N’-ethylcarbodiimide and N-hydroxysuccimide to activated a polyacrylamide polymer for reaction with a primary amine (pg. 3). The activator is added to the polymer to prepare an activated polymer prior to the addition of the amine in a two step process. Fong et al. and Cristine de Silveira et al. are analogous art as they are concerned with the same technical difficulty, namely reacting a polyacrylamide polymer with a primary amine. It would have been obvious to a person of ordinary skill in the art to have added the activating agent of Cristine de Silveira et al. to the polymer of Fong et al. prior to the addition of the amine dye, and the motivation to do so would have been, as Cristine de Silveira et al. suggests, the reaction has high efficiency without the need for elevated temperature or organic solvents (Abstract).
Fong et al. does not teach a buffer being used with the amine dye. However, Madison et al. teaches that the carbodiimide assisted reaction between an amine and a carboxylic acid results in the release of protons that will alter the pH of the system absent a buffer (pg. 13548). Further, Madison et al. teaches the ideal pH for the activation is 4.75/about 5 and the ideal pH for the amidation is 7 (pg. 13551). Fong et al. and Madison et al. are analogous art as they are concerned with the same technical difficulty, namely reacting a carboxylic acid with a primary amine dye. It would have been obvious to a person of ordinary skill in the art to have controlled the pH of the two stages of the reaction of Fong et al. through a buffer solution, as Madison et al., and the motivation to do so would have been, as Madison et al. suggests, to keep the pH at the ideal for the reaction.
Considering Claim 25: Fong et al. teaches the polymer as being an anionic polyacrylamide (Example 33).
Claims 20, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Fong et al. (US Pat. 5,128,419) in view of Cristine de Silveira et al. (J. APPL. POLYM. SCI. 2015, 42797, pg. 1-9) and Madison et al. (Ind. Eng. Chem. Res. 2013, 52, 13547−13555).
Considering Claim 20: Fong et al. teaches a process for labeling a polymer with a dye (2:63-68) comprising a polymer comprising carboxylic acid groups or amide groups/groups convertible to a carboxyl group (4:63-5:8), wherein the dye comprises an amino group (3:36-47), the method comprising mixing the polymer with a buffer solution, and mixing the polymer with a dye to form a dye labeled polymer (Example 33).
Fong et al. does not teach including an activating agent. However, Cristine de Silveira et al. teaches using a combination of N-(3-dimethylaminopropyl)-N’-ethylcarbodiimide and N-hydroxysuccimide to activated a polyacrylamide polymer for reaction with a primary amine (pg. 3). The activator is added to the polymer to prepare an activated polymer prior to the addition of the amine in a two-step process. Fong et al. and Cristine de Silveira et al. are analogous art as they are concerned with the same technical difficulty, namely reacting a polyacrylamide polymer with a primary amine. It would have been obvious to a person of ordinary skill in the art to have added the activating agent of Cristine de Silveira et al. to the polymer of Fong et al. prior to the addition of the amine dye, and the motivation to do so would have been, as Cristine de Silveira et al. suggests, the reaction has high efficiency without the need for elevated temperature or organic solvents (Abstract).
Considering Claim 21: Fong et al. teaches the polymer as having a molecular weight of 10 MDa (Example 41).
Considering Claim 23: Fong et al., Cristine de Silveira et al., and Madison et al. collectively do not teach the claimed concentration of EDC and NHS. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05. It would have been obvious to a person of ordinary skill in the art to have optimized the concentration of the activator and the motivation to do so would have been, to optimize the reaction rate between the amine and the polymer.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Fong et al. (US Pat. 5,128,419) in view of Cristine de Silveira et al. (J. APPL. POLYM. SCI. 2015, 42797, pg. 1-9) and Madison et al. (Ind. Eng. Chem. Res. 2013, 52, 13547−13555) as applied to claim 1 above, and further in view of Kuruppuarachchi et al. (Mol. Pharmaceutics 2011, 8, 920–931).
Considering Claim 16: Fong et al., Cristine de Silveira et al., and Madison et al. collectively teach the process of claim 1 as shown above.
Fong et al. does not teach sonication to provide a dispersion of the precipitate. However, Kuruppuarachchi et al. teaches forming a modified polyacrylamide precipitate by sonication for 30 seconds of 3 minutes in water to provide a polymer dispersion (pg. 923). Fong et al. and Kuruppuarachchi et al. are analogous art as they are concerned with the same field of endeavor, namely modifed polyacrylamide particles. It would have been obvious to a person of ordinary skill in the art to have dispersed the particles of Fong et al. through sonication, as Kuruppuarachchi et al., and the motivation to do so would have been, to allow for particle size and imaging testing (pg. 923).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Fong et al. (US Pat. 5,128,419) in view of Cristine de Silveira et al. (J. APPL. POLYM. SCI. 2015, 42797, pg. 1-9) and Madison et al. (Ind. Eng. Chem. Res. 2013, 52, 13547−13555) as applied to claim 1 above, and further in view of Fong ‘092 (US Pat. 4,703,092).
Considering Claim 16: Fong et al., Cristine de Silveira et al., and Madison et al. collectively teach the process of claim 1 as shown above.
Fong et al. does not teach vacuum drying the precipitate. However, Fong ‘092 teaches using vacuum distillation to remove residual solvent from a polyacrylamide derivative precipitate (6:50-65). Fong et al. and Fong ‘092 are analogous art as they are concerned with the same field of endeavor, namely modified polyacrylamides. It would have been obvious to a person of ordinary skill in the art to have vacuum dried the polymer particles of Fong et al., as in Fong ‘092, and the motivation to do so would have been, it is a conventional drying means for polymer particles.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05. It would have been obvious to a person of ordinary skill in the art to have optimized the drying conditions, namely the temperature, drying time, and pressure through routine experimentation, and the motivation to do so would have been, to recover as much of the solvent as possible from the polymer particles.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIAM J HEINCER whose telephone number is (571)270-3297. The examiner can normally be reached M-F 7:30-5:00.
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/LIAM J HEINCER/Primary Examiner, Art Unit 1767
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