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 .
Status of Claims
Claims 1 – 15 are pending.
Claims 1 -15 are rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1 – 14 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for a construction method of a microtube-based ionic liquid colloid/water interface comprised of: mixing the poly(1-butyl-3-vinylimidazolium bis(trifluoromethanesulfonyl)imide (formula b) with an ionic liquid of C10M (for formula a), then adding the potassium ionophore of formula (c). The specification does not reasonably provide enablement for a process forming the microtube-based ionic liquid colloid/water interface wherein any synthesized poly(ionic liquid) can be added to any potassium ionophore, and that mixture can then be added to any synthesized ionic liquid. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The Examiner combined the rejection for claims 1-7 and 8 - 14 because claim 8 is a product by process claim dependent on the product produced by the method of claim 1. However, the process of claim 1 does not clearly provide a ionic liquid colloid/water interface because, the ionic liquid, poly ionic liquid and potassium ionophore structures are not defined. As such, the lack of enablement that applies to claim 1 is applicable to claim 8.
The test for enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the specification coupled with information known in the art without undue experimentation (United States v. Telectronice, 8, USPQ2D 1217 (Fed. Cir, 1988). Whether undue experimentation is needed is not based upon a single factor but rather in a conclusion reached by weighing many factors. The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
The Federal Circuit has repeatedly held that "the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’." (In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)).
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention: A construction method for a microtube-based ionic liquid colloid/water interface.
(2) the scope of the claims: The scope of the claims are drawn to constructing the microtube-based ionic liquid colloid/water interface wherein any synthesized poly(ionic liquid) can be added to any synthesized potassium ionophore, and that mixture can then be added to any synthesized ionic liquid.
(3) The state of the prior art: There is no evidence of record that the ionic liquid colloid/water interface as described in claim 1 have been formed.
Lindner et al. discloses the bis-crown ether based potassium ionophore BME 44. (entire document). The Lindner article provide data the prove the sensor capabilities for clinical and physiological potassium determinations using BME 44.
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The state of the prior art involves pharmacology and general chemistry. Thesetechnological areas, especially, pharmacology, involve in vitro and in vivo screening to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific diseases/conditions by a certain mechanism). Thus, there is no absolute predictability even in view of the seemingly high level of skill in the art. It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
(4) the predictability or unpredictability of the art: Chemistry is unpredictable. In reMarzocchi, 439 F2d 220, 169 USPQ 367 para. 3. However, the "predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or know results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. MPEP 2164.03.
The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991).
(5) The relative skill of those in the art: The level of skill in the art is high, as the majority of lead investigators directing scientific research and development in this particular technology area possess a Ph.D. in a scientific discipline such as organic synthetic chemistry, medicinal chemistry, biochemistry, pharmacology, biology or the like.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided guidance for a construction method of a microtube-based ionic liquid colloid/water interface comprised of: mixing the poly(1-butyl-3-vinylimidazolium bis(trifluoromethanesulfonyl)imide (formula b) with an ionic liquid of C10M (for formula a), then adding the potassium ionophore of formula (c). According to the disclosure and examples, the above ionic liquid colloid/water interface constructed based on microtubes is able to selectively assist the migration of potassium ions from aqueous phase to organic phase. Also, it is able to interface with high stability, high selectivity and high resistance to protein contamination.
However, the specification does not provide a process forming the microtube-based ionic liquid colloid/water interface wherein any synthesized poly(ionic liquid) can be added to any potassium ionophore, and that mixture can then be added to any synthesized ionic liquid.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to forming the combinations of ionic liquids that provided ionic liquid colloid/water interface and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Claim Rejections - 35 USC § 112
Claim 15 is rejected under 35 U.S.C. 112(a), because the specification, while being enabling for detection of K+ in vitro by a microtube-based method using an ionic liquid colloid/water interface comprised of a mixture of poly(1-butyl-3-vinylimidazolium bis(trifluoromethanesulfonyl)imide (formula b) with an ionic liquid of C10M (for formula a), with the addition of potassium ionophore of formula (c). The specification does not reasonably provide enablement for detection of K+ in vitro by a microtube-based method using an ionic liquid colloid/water interface wherein any synthesized poly(ionic liquid) can be added to any potassium ionophore, and that mixture further being added to any synthesized ionic liquid. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The standards for the test for enablement is discloses in section 5 above.
(1) The nature of the invention: the nature of the inventio is a method for detecting K+ in vitro using a microtube-based ionic liquid colloid/water interface, comprising the following steps: adding a solution containing a certain concentration of K+ into an aqueous phase of the ionic liquid colloid/water interface according to claim 8, placing two silver wires coated with silver chloride in an ionic liquid colloidal phase and the aqueous phase, respectively; applying a voltage, such that the K+ migrates from the aqueous phase to an organic phase under a synergistic effect of an electric field and an ionophore; recording a current magnitude of the K+ migrating at the interface by differential pulse voltammetry (DPV), thereby achieving quantitative detection of the K+ in vitro.
(2) the scope of the claims: The scope of the claim is drawn to detection of K+ in vitro by a microtube-based method using an ionic liquid colloid/water interface wherein any synthesized poly(ionic liquid) can be added to any potassium ionophore, and that mixture further being added to any synthesized ionic liquid.
(3) The state of the prior art: There is no evidence of record that the ionic liquid colloid/water interface as described in claim 1 have been formed and has use in detection of K+ in vitro by a microtube-based method.
Lindner et al. discloses the bis-crown ether based potassium ionophore BME 44. (entire document). The Lindner article provide data the prove the sensor capabilities for clinical and physiological potassium determinations using BME 44.
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The state of the prior art involves pharmacology and general chemistry. Thesetechnological areas, especially, pharmacology, involve in vitro and in vivo screening to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific diseases/conditions by a certain mechanism). Thus, there is no absolute predictability even in view of the seemingly high level of skill in the art. It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
(4) the predictability or unpredictability of the art: Chemistry is unpredictable. In reMarzocchi, 439 F2d 220, 169 USPQ 367 para. 3. However, the "predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or know results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. MPEP 2164.03.
The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991).
(5) The relative skill of those in the art: The level of skill in the art is high, as the majority of lead investigators directing scientific research and development in this particular technology area possess a Ph.D. in a scientific discipline such as organic synthetic chemistry, medicinal chemistry, biochemistry, pharmacology, biology or the like.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided guidance for a construction method of a microtube-based ionic liquid colloid/water interface comprised of: mixing the poly(1-butyl-3-vinylimidazolium bis(trifluoromethanesulfonyl)imide (formula b) with an ionic liquid of C10M (for formula a), then adding the potassium ionophore of formula (c). According to the disclosure and examples, the above ionic liquid colloid/water interface constructed based on microtubes is able to selectively assist the migration of potassium ions from aqueous phase to organic phase. Also, it is able to interface with high stability, high selectivity and high resistance to protein contamination.
However, the specification does not provide a process forming the microtube-based ionic liquid colloid/water interface wherein any synthesized poly(ionic liquid) can be added to any potassium ionophore, and that mixture can then be added to any synthesized ionic liquid.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to forming the combinations of ionic liquids that provided ionic liquid colloid/water interface that would provide the requirements for detection of potassium in vitro and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bereczki et al. (Synthesis and characterization of covalently immobilized bis-crown ether based potassium ionophore, Analyst 2005, pp. 63 – 70).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YATE' K. CUTLIFF whose telephone number is (571)272-9067. The examiner can normally be reached Monday-Friday (8:30 - 5:30).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y. Goon can be reached at (571) 270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YATE' K CUTLIFF/Primary Examiner, Art Unit 1692
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