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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The following limitations are interpreted under 112(f), and their corresponding structure is presented.
Generic Placeholder plus functional language
Corresponding Structure from instant specification
Liquid sending unit
[0029] – pump
Sample injection unit
[0039] – hand operated manual injector or an automatic autosampler
Temperature regulating means
[0043] – heater, Peltier device, heat pump
Control means for controlling the temperature regulating means
[0049] - microcomputer
Regarding limitations recited in Claims 9-12 which are directed to a manner of operating disclosed liquid chromatographic apparatus, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim.
For example, in Claim 9, lines 3-4, “containing threonine, serine, glycine, and alanine” are materials and articles worked upon. In another example, in Claim 9, lines 10-12, “such that column temperature when separating threonine and serine is higher than column temperature when separating glycine and alanine” is a manner of operation.
Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. See Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App & Inter. 1987) that states a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (“Amino acid analysis using ion-exchange chromatography: a review”) in view of Hamilton (“Ion exchange chromatography of amino acids”) and Baily (“Techniques used in 25 years of quantitative ion exchange chromatography of amino acids”).
With regard to Claims 1 and 2, Singh et al (Singh) discloses that the perfect method for the determination of the amino acid composition of pure protein feeds or biological fluids is still the ion exchange column chromatography (Abstract). Singh discloses a method of analyzing amino acids using a liquid chromatographic apparatus equipped with a cation exchange column (Abstract; Page 759, Column 1, separation of amino acids on sulfonated negatively charged column; at low pH, all amino acids will bear a positive charge (i.e., cation exchange column)).
Singh discloses a process for distributing a sample containing threonine, serine, glycine, and alanine as the amino acids, together with the eluent, to the cation exchange column to separate threonine, serine, glycine, and alanine (Page 758/Ion Exchange Chromatography of Amino Acids, after sample preparation, sodium or lithium buffers (eluent) are prepared for separation of the amino acids by ion exchange chromatography; Page 760, Column 2; Page 761, Column 1, all of threonine, serine, glycine, and alanine are discussed as being amino acids that are separated by the methods).
Singh discloses that the optimum temperature for separating threonine and serine is 37-38°C (Page 760, Column 2). Singh discloses that the temperature affects the separation in two different ways: by changing the pH and by altering the affinity of the amino acids to the ion exchange resin (Page 760, Column 2).
However, Singh is silent to wherein column temperature when separating threonine and serine is higher than a column temperature when separating glycine and alanine (Claim 1), wherein threonine and serine have shorter retention times than glycine and alanine, and glycine and alanine are eluted by decreasing column temperature after threonine and serine are eluted (Claim 2).
In addition to Singh, Hamilton in 1963 disclosed complete separation of threonine, serine, glycine, and alanine on a Dowex 50 (i.e., cation exchange column) at 60°C, with serine and threonine eluted before glycine and alanine (Page 2059). Furthermore, Baily in 1975 disclosed previous experimental complete separation of threonine, serine, glycine, and alanine on a Dowex 50 at 37.5°C, with serine and threonine eluted before glycine and alanine, followed by a temperature gradient up to 75°C (Page 362, Figure 2).
Therefore, Singh, Hamilton, and Baily all demonstrate that temperature is a known variable for optimizing the separation of amino acids on a cation exchange column, and that change in temperature yields only predictable results of changing the pH and altering the affinity of the amino acids to the ion exchange resin.
Furthermore, Applicant’s data in Figures 7 and 8 do not show that change in temperature alone resulted in complete separation of alanine and glycine. Finally, Applicant has not identified any other variables for optimizing the separation of these amino acids that were not already known to chromatographers over 60 years ago. MPEP § 2144.05(II)(A) cites In re Williams, 36 F.2d 436, 438 (CCPA 1929) to state that "[i]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
As the temperature is a variable that can be modified, among others, by optimizing the pH and by altering the affinity of the amino acids to the ion exchange resin, the precise temperature gradient programming for separation of amino acids on a cation exchange column would been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed wherein column temperature when separating threonine and serine is higher than a column temperature when separating glycine and alanine (Claim 1), wherein threonine and serine have shorter retention times than glycine and alanine, and glycine and alanine are eluted by decreasing column temperature after threonine and serine are eluted (Claim 2) cannot be considered critical. See Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989)(Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the column temperature gradient in the method of Singh, as taught by Singh, Hamilton, and Baily, to optimize the pH and affinity of the amino acids to the ion exchange resin for complete separation of threonine, serine, glycine, and alanine on a cation exchange column (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969)), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See also MPEP §2144.05(II)(A).
With regard to Claims 3 and 4, Singh discloses wherein the eluent contains at least one selected from a group consisting of a sodium citrate buffer solution, a lithium citrate buffer solution, and a sodium sulfate aqueous solution (Page 760/Buffer systems for separation of the amino acids; Page 761, Tables 2 and 3, sodium citrate or lithium citrate buffers).
With regard to Claims 5-8, Singh discloses that the eluent contains an organic solvent (Page 760, Column 2, the organic solvent added to the first buffer changes the solubility of the different amino acids). Singh discloses that it is particularly the extra -CH3 group of threonine as compared to serine that results in melioration in separation (Page 760, Column 2). Singh discloses that the drawback of using organic solvent as used for separation of threonine and serine is a slight loss of separation between glycine and alanine and increased back pressure (Page 760, Column 2).
However, modified Singh is silent to the organic solvent in the eluent when separating threonine and serine has a higher concentration than the organic solvent in the eluent when separating glycine and alanine.
Singh discloses that the separation between serine and threonine is enhanced by the organic solvent, but that the separation between alanine and glycine is diminished by the organic solvent. Therefore, the solution that the organic solvent in the eluent when separating threonine and serine has a higher concentration than the organic solvent in the eluent when separating glycine and alanine naturally flows from the teachings of Singh.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the organic solvent in the eluent of modified Singh when separating threonine and serine has a higher concentration than the organic solvent in the eluent when separating glycine and alanine, since the separation between serine and threonine is enhanced by the organic solvent, but the separation between alanine and glycine is diminished by the organic solvent.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (“Amino acid analysis using ion-exchange chromatography: a review”) in view of Sanford (“An introduction to HPLC instrumentation”) and .
With regard to Claim 9, Singh et al (Singh) discloses that the perfect method for the determination of the amino acid composition of pure protein feeds or biological fluids is still the ion exchange column chromatography (Abstract). Singh discloses a liquid chromatographic apparatus comprising a liquid sending unit configured to send an eluent to a flow path (Page 761, top of section of page, pumps are pulse-free and feature an even power output and their utilization guarantees conformity of the retention times of individual peaks).
Singh discloses a cation exchange column provided downstream of the sample injection unit to separate sample components in the sample (Abstract; Page 759, Column 1, separation of amino acids on sulfonated negatively charged column; at low pH, all amino acids will bear a positive charge (i.e., cation exchange column)).
Singh discloses that temperature during the amino acid separation is desired to be controlled, including using temperature gradients (Page 760, Column 2). Singh discloses that the temperature affects the separation in two different ways: by changing the pH and by altering the affinity of the amino acids to the ion exchange resin (Page 760, Column 2).
However, Singh is silent to a sample injection unit provided downstream of the liquid sending unit to inject a sample into the eluent in the flow path, a temperature regulating means for regulating column temperature of the cation exchange column, and a control means for controlling the temperature regulating means.
Sanford discloses an introduction to HPLC instrumentation (Slide 1). Sanford discloses a sample injection unit provided downstream of the liquid sending unit to inject a sample into the eluent in the flow path (Slides 26-32, autosampler allows sample to be drawn while pump is in bypass position, and then injected into the eluent in the flow path by switching the valve position).
Sanford discloses a temperature regulating means for regulating column temperature of the cation exchange column (Slides 34-35, high efficiency heat exchangers for maintaining excellent temperature accuracy and precision within a column compartment).
Sanford discloses a control means for controlling the temperature regulating means (Page 46, method setup software including for column compartment).
Sanford discloses that control of the pump, sampler, column thermostat, and detector will optimize retention time, resolution, and sensitivity (Page 63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the liquid chromatography apparatus of Singh to comprise a sample injection unit provided downstream of the liquid sending unit to inject a sample into the eluent in the flow path, a temperature regulating means for regulating column temperature of the cation exchange column, and a control means for controlling the temperature regulating means, as taught by Sanford, in order to optimize retention time, resolution, and sensitivity in the liquid chromatography apparatus.
Therefore, the liquid chromatography apparatus of modified Singh is capable of injecting a sample containing threonine, serine, glycine, and alanine into the eluent in the flow path, and is capable of controlling the temperature regulating means such that column temperature when separating threonine and serine is higher than column temperature when separating glycine and alanine.
With regard to Claim 10, the liquid chromatographic apparatus of Singh is capable of separating threonine and serine such that they have shorter retention times than glycine and alanine. Furthermore, the control means in the liquid chromatographic apparatus of Singh is capable of controlling the temperature regulating means such that glycine and alanine are eluted by decreasing column temperature after threonine and serine are eluted.
With regard to Claims 10 and 11, the eluent of modified Singh is capable of containing an organic solvent. However, modified Singh is silent to the control means further controlling the liquid sending unit such that the organic solvent in the eluent has a higher or lower concentration at different times during the analysis.
Sanford discloses that different solvents or buffers contained in solvent bottles can be proportioned in a proportioning valve before flowing to the pump head (Slides 10 and 14). The solvents and buffers can be mixed in different proportions to form a gradient for elution and separation of sample components (Page 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the control means of modified Sing to further control the liquid sending unit such that the organic solvent in the eluent has a higher or lower concentration at different times during the analysis, as taught by Sanford, in order to mix solvents and buffers in different proportions to form a gradient for elution and separation of sample components. Therefore, the control means of modified Singh are capable of further controlling the liquid sending unit such that the organic solvent in the eluent when separating threonine and serine has a higher concentration than the organic solvent in the eluent when separating glycine and alanine.
Conclusion
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Benjamin Lebron
Primary Examiner
Art Unit 1777
/BENJAMIN L LEBRON/Primary Examiner, Art Unit 1777
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