DETAILED ACTION
In application filed on 04/14/2023, Claims 1-10 and 18-30 are pending. The claim set submitted on 07/10/2026 is considered because this is the most recent claim set with some preliminary amendments. Claims 1-10 and 18-20 are considered in the current office 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 with traverse of Group I (claims 1-10 and 18-20) in the reply filed on 07/10/2026 is acknowledged. The traversal is on the ground(s) that:
The Applicant traverses these requirements at least on the grounds that no undue burden would be required to examine the claims of Groups I and III together. The Examiner has not demonstrated a serious search burden that would justify the restriction. The claimed inventions significantly overlap in subject matter and would likely be found in the same fields of search. The claims of Groups I and III are closely related and share common features, including the step of "derivatizing the sample obtained from (a) by contacting it with O- Phthalaldehyde (OPA)" which would result in substantially overlapping search strategies. Moreover, examination of these related Groups together would promote compact prosecution and be more efficient for both the Examiner and the Applicant.
Should these requirements be maintained, the Applicant respectfully requests rejoinder of the nonelected claims at the conclusion of prosecution. Consistent with the requisite unity of invention practice, "when all of the claims drawn to the elected invention are allowable ... the nonelected invention(s) should be considered for rejoinder...." M.P.E.P.§ 1893.03(d). See also M.P.E.P. § 821.04 ("The propriety of a restriction requirement should be reconsidered when all the claims directed to the elected invention are in condition for allowance, and the nonelected invention(s) should be considered for rejoinder.").
This is not found persuasive because the inventions as claimed are independent or distinct as set forth in the restriction requirement of 05/12/2026 and a serious search and /or examination burden exists for the reasons previously given and as further explained below. See MPEP 803.
I. Claims 1-10 and 18-20, drawn to a method, classified in G01N33/582.
II. Claims 11-17, drawn to a method, classified in G01N 33/49.
III. Claim 21-30, drawn to a method of manufacturing an integrated device, classified in C02F 2209/005.
Examiner submits that Applicant’s assertion that the claimed inventions significantly overlap in subject matter and would likely be found in the same fields of search does not overcome the presentation of a different field of search and separate status in the inventions.
Examiner further asserts that overlap of some claim language or shared concept does not preclude the existence of search burden when the inventions as claimed clearly require different search strategies
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-17 are canceled and Claims 21-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/10/2026.
Group I, claims 1-10 and 18-20 are considered on the merits below.
Claim Objections
Claims 18 and 20 are objected to because of the following informalities:
Claim 18 is objected under 37 CFR 1.75 as being a substantial duplicate of claim 9. In addition, Claim 20 is objected under 37 CFR 1.75 as being a substantial duplicate of claim 10.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
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.
Claim 8 is 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.
Claim 8 recites the limitation "the mobile phase". There is insufficient antecedent basis for this limitation in the claim.
For the purpose of expedited examination, Examiner interprets “the mobile phase" as “a mobile phase"
Applicant should provide clarification.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. All claims are directed to statutory categories, i.e., a method (Claims 1-10 and 18-20) (Step 1: YES).
Analysis:
Claim 1: Ineligible.
Step 1:
The claim recites a series of steps or acts, including “method for detecting amino acids in a sample volume of 50 µL or less”. Thus, the claim is directed to a method, which is one of the statutory categories of invention (Step 1: YES).
Step 2A Prong 1:
Claim 1 recites “(d) detecting RP-HPLC resolved fractions or components as they elute from the RP-HPLC column by ultraviolet illumination (mental step)”.
Therefore, the claim is directed towards an abstract idea, and more specifically to the abstract idea group of a mental processes since claim 1 relates to using a mental process to “detect amino acids in a sample volume of 50µL or less” (Step 2A, Prong 1: Patent Ineligible).
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application.
Once the detecting is done, No further action takes place.
Also the steps of “ removing proteins from a sample,(b) derivatizing the sample obtained from (a) by contacting it with O- Phthalaldehyde (OPA),(c) injecting the derivatized sample from (b) into a RP-HPLC column to produce fractions” are recited at a high level of generality that it amounts to mere data gathering (insignificant extra-solution activity). See MPEP 2106.05(g).
Step 2B:
Furthermore, the courts have found that limitations adding insignificant extrasolution activity to the judicial exception, such as mere data gathering in conjunction with a law of nature or abstract idea, are limitations found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception (see the 2014 Interim Guidance on Patent Subject Matter Eligibility of the Federal Register dated December 16, 2014; and MPEP 2106.05(I)(A)). Note that mere data gathering is not significantly more than the abstract idea. See MPEP 2106.05(g).
Here, there are no additional elements which are significantly more than the abstract idea. The steps of “removing proteins from a sample,(b) derivatizing the sample obtained from (a) by contacting it with O- Phthalaldehyde (OPA),(c) injecting the derivatized sample from (b) into a RP-HPLC column to produce fractions” appears to be well-understood, routine, and conventional (WURC) in the field of clinical diagnostics, as evidenced by Gałęzowska et al. ("Determination of amino acids in human biological fluids by high-performance liquid chromatography: critical review." Amino Acids 53.7 (2021): 993-1009.) (Step 2B: NO).
Therefore, Claim 1 is ineligible.
Moreover, Claims 2-10 and 18-20 are rejected by virtue of their dependency on Claim 1.
Also, each of the dependent claims 2-10 and 18-20 do not solve the issues of claim 1.
Claims 10 and 19-20: Ineligible.
Step 2A, Prong One and Prong Two: Claims 10 and 19-20 further presents an abstract ideas “detecting the fractions comprises illuminating the fractions with UV light at a wavelength of 338 nm + 20 nm; detecting the fractions comprises illuminating the fractions with UV light at a wavelength of 200-400 nm; and detecting the fractions comprises illuminating the fractions with UV light at a wavelength of 338 nm + 20 nm” and further define the data gathering steps which appear to be generic and WURC.
Step 2B: The claims do not recite any elements which are significantly more.
Therefore, Claims 10 and 19-20 are ineligible.
Claims 2-9 and 18: Ineligible.
Step 2A, Prong One and Prong Two: Claims 2-9 and 18 further define the data gathering steps, which appear to be generic and WURC.
Step 2B: The claims do not recite any elements which are significantly more.
Therefore, Claims 2-9 and 18 are ineligible.
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 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.
Claims 1-6 and 19 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Gałęzowska et al. ("Determination of amino acids in human biological fluids by high-performance liquid chromatography: critical review." Amino Acids 53.7 (2021): 993-1009.).
Regarding Claim 1, Gałęzowska teaches a method for detecting amino acids in a sample volume of 50 µL or less (See Para 1000…HPLC has become one of the priority methods of choice for analyzing AAs.; See Page 1000…The sample volumes typically used for HPLC analysis are 20–50 µL; See Page 994…Amino acids (AAs) are organic compounds, derivatives of hydrocarbons) comprising:
removing proteins from a sample (See Page 995…Consequently, to relate the content of AA compounds in the final extract to their concentration in body fluids, using proper sample storage, cleaning up to remove salts or proteins or derivatization are needed; See Para 1000… Several methods for deproteinization of biological samples are known)),
derivatizing the sample obtained from (a) by contacting it with O- Phthalaldehyde (OPA) (See Para 1000…the identification and quantitation of AAs in biological samples was performed by high-performance liquid chromatography (HPLC) analysis with fluorescence detection (FLD), after derivatization of compounds with o-phthalaldehyde/ mercaptoethanol (OPA)…)
injecting the derivatized sample from (b) into a RP-HPLC column to produce
fractions (See Page 1001...Reversed-phase (RP)-HPLC has become the most commonly used chromatography mode; See Para 1001…RP columns designed specifically for AA separation are more hydrophobic than classical C18 columns. Various C18 columns continue to be employed for the analysis of AAs as they provide good separation for a wide range of analytes…derivatization can be used (see sample preparation chapter)), and
detecting RP-HPLC resolved fractions or components (See Para 1005…The isolation of the substance is extremely important to identify the compounds on the basis on parent and fragment anions, represented as chromatographic peaks of individual compounds, thereby teaching “RP-HPLC resolved fractions or components”) as they elute from the RP-HPLC column by ultraviolet illumination (See Para 1001…The most common detection techniques connected with HPLC are UV or/and Vis absorbance, but not for the analysis of AAs. Diode-array detector (DAD) is an advanced UV–Vis detector commonly used to simultaneously and continuously acquire UV–Vis data with arrays of usually 512 photo-diodes; See Table 2, Summary of HPLC parameters of human fluids containing amino acids …UV–VIS).
Regarding Claim 2, Gałęzowska teaches that the sample (See Abstract… For this reason, the review has focused on three types of samples, namely urine, blood and cerebrospinal fluid.) has a volume of 25 µL or less (See Page 1000…The sample volumes typically used for HPLC analysis are 20–50 µL).
Regarding Claim 3, Gałęzowska teaches that the sample (See Abstract… For this reason, the review has focused on three types of samples, namely urine, blood and cerebrospinal fluid.) is obtained from a subject with an in-born error (See Introduction; Page 994…Inborn error of metabolism can be determined on the basis of the amino acid profile; Examiner submits that the claimed “subject” is implied under BRI) of metabolism including maple syrup urine disease, phenylketonuria, organic acidemias, homocystinuria, tyrosinemia, and urea cycle disorders (See Page 994…The levels of phenylalanine, leucine, valine, citrulline and methionine have been determined for the diagnosis of phenylketonuria, maple syrup urine disease, citrullinemia and homocystinuria, respectively).
Regarding Claim 4, Gałęzowska teaches that the sample (See Abstract… For this reason, the review has focused on three types of samples, namely urine, blood and cerebrospinal fluid.) comprises blood, plasma, or serum (See Abstract… For this reason, the review has focused on three types of samples, namely urine, blood and cerebrospinal fluid.).
Regarding Claim 5, Gałęzowska teaches that the sample (See Abstract… For this reason, the review has focused on three types of samples, namely urine, blood and cerebrospinal fluid.) comprises cerebral spinal fluid, synovial fluid, lymph, peritoneal fluid, amniotic fluid, saliva, breast milk, gastric juice, bile, perspiration, tears, semen, vaginal secretions, breast milk, ascitic fluid, mucous, urine or pus (See Abstract… For this reason, the review has focused on three types of samples, namely urine, blood and cerebrospinal fluid.).
Regarding Claim 6, Gałęzowska teaches wherein (a) the removing of proteins from the sample (See Para 1000… Several methods for deproteinization of biological samples are known) comprises spin filtering the sample without dilution or acid precipitation (See Para 1000… Several methods for deproteinization of biological samples are known. The most commonly used are precipitation with acids and an organic solvent.).
Regarding Claim 19, Gałęzowska teaches wherein (d), detecting the fractions (See Para 1005…The isolation of the substance is extremely important to identify the compounds on the basis on parent and fragment anions, represented as chromatographic peaks of individual compounds, thereby teaching “detecting the fractions”) comprises illuminating the fractions with UV light (See Page 1001…The most common detection techniques connected with HPLC are UV or/and Vis absorbance, but not for the analysis of AAs. Diode-array detector (DAD) is an advanced UV–Vis detector commonly used to simultaneously and continuously acquire UV–Vis data with arrays of usually 512 photo-diodes) at a wavelength of 200-400 nm (See Table 2… Summary of HPLC parameters of human fluids containing amino acids… UV–VIS, 210 nm).
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 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 7, 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gałęzowska et al. ("Determination of amino acids in human biological fluids by high-performance liquid chromatography: critical review." Amino Acids 53.7 (2021): 993-1009.) as applied to claim 1 above, and further in view of Heidebrecht et al. (US20220349896A1).
Regarding Claim 7, Gałęzowska teaches wherein (b) derivatizing the sample comprises derivatizing the sample from (a) with O-Phthalaldehyde (OPA) (See Para 1000…the identification and quantitation of AAs in biological samples was performed by high-performance liquid chromatography (HPLC) analysis with fluorescence detection (FLD), after derivatization of compounds with o-phthalaldehyde/ mercaptoethanol (OPA)…) ; an RT-HPLC injector needle (See Page 1006…an injector); and the column (See Page 1006…See Page 1001...Reversed-phase (RP)-HPLC has become the most commonly used chromatography mode; See Para 1001…RP columns designed specifically for AA separation are more hydrophobic than classical C18 columns.).
Gałęzowska does not expliclty teach “derivatizing the sample comprises derivatizing the sample from (a) with O-Phthalaldehyde (OPA) on an RT-HPLC injector needle immediately before injection into the column”.
In the analogous art for methods for evaluating polymer compositions comprising polymers modified with a polypeptide (e.g., a cell-binding polypeptide), including methods for determining polypeptide concentration, Heidebrecht teaches “derivatizing the sample comprises derivatizing the sample from (a) with O-Phthalaldehyde (OPA) (See Para 0152… individual amino acids may subsequently be derivatized (e.g., by automated pre-column on-line derivatization), using derivatizing agents (e.g., ortho-phthalaldehyde (OPA) in the case of primary amino acids, or 9-fluoroenylmethyl chloroformate (Fmoc) in the case of secondary amino acids) on an RT-HPLC injector needle (See Para 0152…) (e.g., by automated pre-column on-line derivatization)) immediately before injection into the column (See Para 0152…The derivatized amino acids may then be immediately separated and analyzed by liquid chromatography.)”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a method of Gałęzowska to include ““derivatizing the sample comprises derivatizing the sample from (a) with O-Phthalaldehyde (OPA) on an RT-HPLC injector needle immediately before injection into the column”, as taught by Heidebrecht, for the benefit of determining the total amount of CBP (including both free CBP and conjugated CBP) in a sample of CBP-modified polymer (Heidebrecht, Para 0152), allowing for the provision of methods for evaluating polymer composition comprising a polymer modified with a polypeptide. In an embodiment, the evaluating comprises determining the concentration of the polypeptide within the polymer composition (Heidebrecht, Para 0002).
Regarding Claim 10, Gałęzowska teaches wherein (d), detecting the fractions (See Para 1005…The isolation of the substance is extremely important to identify the compounds on the basis on parent and fragment anions, represented as chromatographic peaks of individual compounds, thereby teaching “detecting the fractions”) comprises illuminating the fractions with UV light (See Page 1001…The most common detection techniques connected with HPLC are UV or/and Vis absorbance, but not for the analysis of AAs. Diode-array detector (DAD) is an advanced UV–Vis detector commonly used to simultaneously and continuously acquire UV–Vis data with arrays of usually 512 photo-diodes) at a wavelength of 210 nm (See Table 2… Summary of HPLC parameters of human fluids containing amino acids).
Gałęzowska does not teach illuminating the fractions with UV light at a wavelength of 338 nm + 20 nm.
In the analogous art for methods for evaluating polymer compositions comprising polymers modified with a polypeptide (e.g., a cell-binding polypeptide), including methods for determining polypeptide concentration, Heidebrecht teaches “illuminating the fractions with UV light at a wavelength of 338 nm +- 20 nm” (See Para 0162… The UV detector was set to a wavelength of 338 nm.) .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a method of Gałęzowska to include “illuminating the fractions with UV light at a wavelength of 338 nm +- 20 nm”, as taught by Heidebrecht, for the benefit of determining the total amount of CBP (including both free CBP and conjugated CBP) in a sample of CBP-modified polymer (Heidebrecht, Para 0152), allowing for the provision of methods for evaluating polymer composition comprising a polymer modified with a polypeptide. In an embodiment, the evaluating comprises determining the concentration of the polypeptide within the polymer composition (Heidebrecht, Para 0002).
Regarding Claim 20, Gałęzowska teaches wherein (d), detecting the fractions (See Para 1005…The isolation of the substance is extremely important to identify the compounds on the basis on parent and fragment anions, represented as chromatographic peaks of individual compounds, thereby teaching “detecting the fractions”) comprises illuminating the fractions with UV light (See Page 1001…The most common detection techniques connected with HPLC are UV or/and Vis absorbance, but not for the analysis of AAs. Diode-array detector (DAD) is an advanced UV–Vis detector commonly used to simultaneously and continuously acquire UV–Vis data with arrays of usually 512 photo-diodes) at a wavelength of 210 nm (See Table 2… Summary of HPLC parameters of human fluids containing amino acids).
Gałęzowska does not teach illuminating the fractions with UV light at a wavelength of 338 nm + 20 nm.
In the analogous art for methods for evaluating polymer compositions comprising polymers modified with a polypeptide (e.g., a cell-binding polypeptide), including methods for determining polypeptide concentration, Heidebrecht teaches “illuminating the fractions with UV light at a wavelength of 338 nm +- 20 nm” (See Para 0162… The UV detector was set to a wavelength of 338 nm.) .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a method of Gałęzowska to include “illuminating the fractions with UV light at a wavelength of 338 nm +- 20 nm”, as taught by Heidebrecht, for the benefit of determining the total amount of CBP (including both free CBP and conjugated CBP) in a sample of CBP-modified polymer (Heidebrecht, Para 0152), allowing for the provision of methods for evaluating polymer composition comprising a polymer modified with a polypeptide. In an embodiment, the evaluating comprises determining the concentration of the polypeptide within the polymer composition (Heidebrecht, Para 0002).
Claims 8-9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gałęzowska et al. ("Determination of amino acids in human biological fluids by high-performance liquid chromatography: critical review." Amino Acids 53.7 (2021): 993-1009.) as applied to claim 1 above, and further in view of Heidebrecht et al. (WO2021062263A1, which is applied as US20220349896A1).
Regarding Claim 8, Gałęzowska teaches wherein in (c) the mobile phase is a binary mobile phase (A) and (B); wherein (A) comprises a mixture of sodium acetate buffer (pH 6.5):acetonitrile (97.5:2.5,v/v) (See Table 2… Summary of HPLC parameters of human fluids containing amino acids) and (B) comprises acetonitrile:methanol:water (45:15:40, v/v/v) (See Table 2… Summary of HPLC parameters of human fluids containing amino acids).
Gałęzowska further teaches that for the mobile phase composition, mainly mixtures of organic solvents with water are used. In general, the separation takes place under gradient conditions. The composition of the phase depends on the choice of detection technique. For mass spectrometer detectors, it is preferable to add modifiers to the phase, such as tridecafluoroheptanoic acid (TDFHA, analysis with an ion pair), acetic acid or formic acid, as well as their sodium or ammonium salts. (See Page 1001, Stationary phase and mobile phase).
Gałęzowska does not explicitly teach wherein in (c) the mobile phase is a binary mobile phase (A) and (B); wherein (A) comprises a mixture of sodium phosphate, sodium borate, and sodium azide, and (B) comprises a mixture of acetonitrile, methanol and water.
However, MPEP § 2144.05, Part II, Subpart B holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In the process of using LC/MS, mobile phase composition controls both chromatographic separation and analyte ionization efficiency. Choosing volatile organic modifiers (like acetonitrile or methanol), aqueous phases, and volatile additives dictates peak resolution, retention times, and mass spectrometer signal response.
Thus, the mobile phase is a binary mobile phase (A) and (B); wherein (A) comprises a mixture of sodium phosphate, sodium borate, and sodium azide, and (B) comprises a mixture of acetonitrile, methanol and water are a result effective variables.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to operate the method of Gałęzowska to include that the mobile phase is a binary mobile phase (A) and (B); wherein (A) comprises a mixture of sodium phosphate, sodium borate, and sodium azide, and (B) comprises a mixture of acetonitrile, methanol, for the benefit of providing a composition of the phase depends on the choice of detection technique (Gałęzowska, Page 1001), allowing using the quantitation and qualification of amino acids in clinical and epidemiological studies, and providing an excellent way of monitoring compounds in human fluids which have not been monitored previously, to prevent some diseases (Gałęzowska, Abstract).
Regarding Claim 9, Gałęzowska teaches wherein (c) comprises RP-HPLC chromatography comprising a run time of some minutes (See Page 1000, HPLC analysis…In contrast, total runtime for an instrumental technique like HPLC could be a few minutes).
Gałęzowska does not explicitly teach a run time of 30 minutes or less.
However, MPEP § 2144.05, Part II, Subpart B holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In the process of using LC/MS, the chromatographic run time directly balances sample throughput against data quality. Shortening the run time increases lab efficiency, but can narrow peaks and lower resolution, while longer runs improve separation at the cost of speed.
Thus, a run time of 30 minutes or less is a result effective variable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to operate the method of Gałęzowska to include a run time of 30 minutes or less, for the benefit of providing choice of detection technique that has a runtime of a few minutes (Gałęzowska, Page 1001), allowing using the quantitation and qualification of amino acids in clinical and epidemiological studies, and providing an excellent way of monitoring compounds in human fluids which have not been monitored previously, to prevent some diseases (Gałęzowska, Abstract).
Regarding Claim 18, Gałęzowska teaches wherein (c) comprises RP-HPLC chromatography comprising a run time of some minutes (See Page 1000, HPLC analysis…In contrast, total runtime for an instrumental technique like HPLC could be a few minutes).
Gałęzowska does not explicitly teach a run time of 30 minutes or less.
However, MPEP § 2144.05, Part II, Subpart B holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In the process of using LC/MS, the chromatographic run time directly balances sample throughput against data quality. Shortening the run time increases lab efficiency, but can narrow peaks and lower resolution, while longer runs improve separation at the cost of speed.
Thus, a run time of 30 minutes or less is a result effective variable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to operate the method of Gałęzowska to include a run time of 30 minutes or less, for the benefit of providing choice of detection technique that has a runtime of a few minutes (Gałęzowska, Page 1001), allowing using the quantitation and qualification of amino acids in clinical and epidemiological studies, and providing an excellent way of monitoring compounds in human fluids which have not been monitored previously, to prevent some diseases (Gałęzowska, Abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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