DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
2. Applicant's arguments received 06/05/2026 have been considered but are moot in view of the new ground(s) of rejection. Detailed response is given in sections 3-6 as set forth below in this Office action.
Regarding the claim eligibility, Applicant argues (REMARKS, p.8-9):
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The Examiner respectfully disagrees. Focusing on what the inventors have invented exactly and giving the broadest reasonable interpretation (BRI) to the claims, the Examiner asserts that the pending claims 1-5 are directed to an abstract idea of mathematically quantifying a plurality of compounds with the same chromophore but without reciting any additional limitation/element that amounts to “significantly more” than the judicial exception.
As discussed in details in section 6 below, based on the Alice framework, the Examiner deems that representative claim 1 is directed to an algorithm of determining a mass concentration of a target compound based on a standard (or reference) compound by using the standard curve technique, under a condition that the target compound shares the same chromophore as the standard compound and exhibits a same absorbance as the standard compound at an equal molar concentration. The “core” of the claimed algorithm is the mathematical relationship as recited in Applicant’s equation 5, through which the mass concentration of a target compound is solved. Under Step 2A – Prong 1, however, that math equation amounts to an abstract idea falling within the “Mathematical Concepts” grouping of Abstract Ideas defined by the 2019 PEG.
Under Step 2A - Prong 2, the Examiner evaluates whether the claim recites any additional element that integrate the judicial exception into a practical application. In the instant case, each of the limitations (a) and (e) encompasses a process of gathering the data/information necessary for performing the abstract idea, which amounts to insignificant pre-solution activities to the judicial exception but are not qualified for significantly more to integrate the identified abstract idea into a practical application. The HPLC is used merely as a tool to gather the data/information necessary for performing the abstract idea. The acts of “obtaining corresponding peak area values” and “obtaining a measured peak area of the target compound” are all recited at a high level of generality. Under the BRI, the “peak area values” and the “measured peak area” are simply the outputs from the HPLC analyses applied to the reference compound and the target compound respectively. As to the limitation (g), under the BRI, it encompasses an insignificant post-solution activity. None of these extra-solution activities is considered to be qualified for “meaningful limitation” because, at most, they only generally link the judicial exception to a particular technological environment or field of use.
Under Step 2B, consideration is given to additional elements that provide an inventive concept (also called "significantly more" than the recited judicial exception). In the instant case, the Examiner considers that representative claim 1 is directed to an algorithm of determining a mass concentration of a target compound based on a reference compound by using the so-called standard curve technique in chromatography. The standard curve (or calibration curve) technique is implemented with the aid of HPLC analysis and a linear equation between two variables, which is deemed to be a common practice in the art. Further, HPLC systems that are capable of automatically calculating peak area (i.e., an integral of the detector signal over the time the peak being above a baseline which area is proportional to the amount of analyte present) using existing chromatography data is "well-understood, routine, conventional" in the art. Similarly, intended practices of HPLC analysis and the standard curve technique for quantitative analytical measurements applied to working solutions with different concentrations of either a reference (calibration) compound or a target compound to be tested are all well-known in the prior art of chromatography. Moreover, the concept of determining an unknown mass concentration of a target compound based on a known calibration compound is also well-understood, routine and conventional. The Examiner asserts that the only element in the claimed algorithm that appears to be distinguishable over the prior art of record is the mathematical relationship as recited in Applicant’s equation 5. Put it differently, Applicant’s claim 1 recites at most an improved abstract idea of mathematically fitting/solving an unknown variable with given known variables. However, an improved abstract idea is still an abstract idea. It is held that simply setting forth advantages (i.e. benefits) of use without providing any rational/evidence to how/why the claimed elements amount to significantly more than the judicial exception does not ascertain any evidence for qualifying an improvement (i.e. enhancement) such as in the functioning of a computer or an improvement to another technology or technical field. The key is to show that the claim goes beyond just performing a calculation and provides a practical application or significant improvement through the use of that calculation. See MPEP 2106.04(d)(I) and 2106.05(a).
Applicant further argues (REMARKS, p.9):
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Examiner respectfully disagrees. Claim 1 of Example 3 of USPTO Subject Matter Eligibility Examples recites a computer-implemented method for halftoning a gray scale image. It is held that the claim is eligible under the 2019 PEG because the claim includes additional limitations (e.g., comparing the blue noise mask to a gray scale image to transform the gray scale image to a binary image array and converting the binary image array into a halftoned image) that tie the mathematical operation (the blue noise mask) to the processor’s ability to process digital images. The claim, when taken as a whole, does not simply describe the generation of a blue noise mask via a mathematical operation and receiving and storing data, but combines the steps of generating a blue noise mask with the steps for comparing the image to the blue noise mask and converting the resulting binary image array to a halftoned image. By this, the claim goes beyond the mere concept of simply retrieving and combining data using a computer.
In the instant case, representative claim 1 combines the steps of generating the 1st, 2nd, and 3rd standard curves with the step for determining a mass concentration of the target compound in the complex sample, then simply outputs the determined mass concentration of the target compound which can be done using paper and pen. It does not even make a mention of a computer or a processor, let alone reciting any additional limitation/element that ties the math/mental operation to the processor’s ability to process such tasks as comparing digital images and converting the resulting binary image array to a halftoned image. Unlike the claim 1 of Example 3, the additional limitations recited in instant claim 1 do not add meaningful limitations to the abstract idea of determining a mass concentration of a target compound based on a standard compound. The decision in Example 3 therefore is not analogous to the instant claims of the present application.
Claim 1 of Example 40 of USPTO Subject Matter Eligibility Examples is directed to a method for adaptive monitoring of traffic data through a network appliance connected between computing devices in a network. The claim recites the combination of additional elements of collecting at least one of network delay, packet loss, or jitter relating to the network traffic passing through the network appliance, and collecting additional Netflow protocol data relating to the network traffic when the collected network delay, packet loss, or jitter is greater than the predefined threshold. It is held that the unique way (that is, the manner of the data collection) of collecting the data is never done before. Thus, the claim as a whole is directed to a particular improvement in collecting traffic data, which results in improved network monitoring. The decision in Example 40 is fact specific and is therefore not analogous to the instant claims of the present application.
The rest of the Applicant’s arguments with respect to the subject matter eligibility are reliant upon the issues discussed above or have been fully addressed in the detailed response as set forth in sections 5-6 below in this Office action. The rejection is therefore maintained.
Rejections - 35 USC § 112
3. 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.
4. Claims 1-5 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 pre-AIA the applicant regards as the invention.
In claim 1, the recitation of “detecting, by …, a series of standard working solutions of a standard compound having different mass concentrations” renders the claim indefinite. It is unclear whether said “detecting” refers to discovering/identifying the presence or existence of “a series of standard working solutions of a standard compound having different mass concentrations” or discovering/identifying something else from said “series of standard working solutions” that have been prepared beforehand.
Claims 2-5 are rejected under 35 U.S.C. 112(b) by virtue of their dependency to claim 1.
Claim Rejections - 35 USC § 101
5. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 101 that form the basis for the rejections under this section made in this Office action:
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.
6. Claims 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Under the 2019 PEG (now been incorporated into MPEP 2106), the revised procedure for determining whether a claim is "directed to" a judicial exception requires a two-prong inquiry into whether the claim recites: (1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human interactions such as a fundamental economic practice, or mental processes); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim: (3) adds a specific limitation beyond the judicial exception that is not "well-understood, routine, conventional" in the field (see MPEP § 2106.0S(d)); or (4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
Claims 1-5 are directed to an abstract idea of quantifying a plurality of compounds with the same chromophore using a single standard.
Specifically, representative claim 1 recites:
A method for quantifying a plurality of compounds with a same chromophore using a single standard, comprising the following steps:
(a) detecting, by high-performance liquid chromatography (HPLC) with a UV detector under defined chromatographic conditions, a series of standard working solutions of a standard compound having different mass concentrations, and obtaining corresponding peak area values;
(b) establishing a first standard curve correlating mass concentrations of the standard compound with the corresponding peak area values;
(c) converting the first standard curve into a second standard curve correlating molar concentrations of the standard compound with the corresponding peak area values according to a relationship between mass concentration and molar concentration of the standard compound;
(d) under a condition that a target compound in a complex sample shares the same chromophore as the standard compound and exhibits a same absorbance as the standard compound at an equal molar concentration, establishing a third standard curve correlating mass concentrations of the target compound with its peak area values according to Equation (5):
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wherein ymeasured represents a peak area of the target compound, xmeasured represents a mass concentration of the target compound, Mr represents a molar mass of the standard compound, Mmeasured represents a molar mass of the target compound, and a and b are parameters;
(e) subjecting the complex sample to HPLC analysis under the same chromatographic conditions and obtaining a measured peak area of the target compound;
(f) determining a mass concentration of the target compound in the complex sample by applying the measured peak area obtained in step (e) to the third standard curve; and
(g) outputting the determined mass concentration as a quantified content of the target compound in the complex sample.
The claim limitations in the abstract idea have been highlighted in bold above; the remaining limitations are “additional elements”.
The highlighted portion of the claim constitutes an abstract idea under the 2019 Revised Patent Subject Matter Eligibility Guidance and the additional elements are NOT sufficient to amount to significantly more than the judicial exceptions, as analyzed below:
Step
Analysis
1. Statutory Category ?
Yes.
Method
2A - Prong 1: Judicial Exception Recited?
Yes.
See the bolded portion as listed above.
Under its broadest reasonable interpretation (BRI), each or the combination of the limitations (b) and (c) encompasses a mental process, i.e. data manipulation, evaluation and/or presentation, that can be performed in the human mind or by a human using a pen and paper. Note, the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. See CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). See also to MPEP 2106.04(a)(2).III
Under its BRI, limitations (d) encompasses mathematical concepts and/or relationships which also encompasses mental processes that can be performed in the human mind or by a human using a pen and paper.
Under its BRI, the limitations (f) encompasses a mental process, i.e. data manipulation, evaluation and/or judgement, that can be performed in the human mind or by a human using a pen and paper.
Nothing in the bolded portion precludes these limitations from practically being performed in the mind and/or with the aid of pen/paper.
Therefore, the bolded portion of instant claim 1, reciting a series of mathematical concepts and mental process, amounts to an abstract idea falling within a combination of the “Mental Process” and “Mathematical Concepts” groupings of Abstract Ideas defined by the 2019 PEG.
2A - Prong 2: Integrated into a Practical Application?
No.
Representative claim 1 recites the additional limitations (a), (e) and (g).
Under its BRI, each of the limitations (a) and (e) encompasses a process of gathering the data/information necessary for performing the abstract idea. MPEP 2106.05(g)(3): … that were described as mere data gathering in conjunction with a law of nature or abstract idea. See also Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 13863, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). Thus, each of the limitations (a) and (e) amounts to an insignificant pre-solution activity to the judicial exception but is not qualified for significantly more to integrate the identified abstract idea into a practical application.
The acts of “obtaining corresponding peak area values” and “obtaining a measured peak area of the target compound” are all recited at a high level of generality. The “peak area values” and the “measured peak area” are merely the outputs generated by applying the HPLC analysis to the reference compound and the target compound respectively for quantification. None of these pre-solution activities is considered to be qualified for meaningful limitation because, at most, they only generally link the judicial exception to a particular technological environment or field of use.
Under the BRI, the limitation (g) encompasses an insignificant post-solution activity. The outputting can be performed, e.g., with the aid of pen and paper to report said determined mass concentration generated from the identified judicial exception.
The claim as a whole does not meet any of the following criteria to integrate the abstract idea into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Various considerations are used to determine whether the additional elements are sufficient to integrate the abstract idea into a practical application. However, in all of these respects, the claim fails to recite additional elements which might possibly integrate the claim into a particular practical application. At most, it only generally links the judicial exception to a particular technological environment or field of use. See MPEP 2106.04(d)(2).
2B: Claim provides an Inventive Concept?
No.
Focusing on what the inventors have invented exactly, it is deemed that the “heart” of the representative claim 1 is directed to an algorithm of determining a mass concentration of a target compound based on a standard (or reference) compound by using a standard curve technique, under a condition that the target compound shares the same chromophore as the standard compound and exhibits a same absorbance as the standard compound at an equal molar concentration. The standard curve (or calibration curve) technique in chromatography, which is implemented with the aid of HPLC analysis and a mathematical relationship between two variables as claimed, is well-known in the art. The concept of determining an unknown mass concentration of a target compound based on a known standard (or calibration) compound is also well-understood, routine and conventional. The only element in the claimed algorithm that appears to distinguish over the prior art of record is the mathematical relationship as recited in equation 5. However, as identified in Step 2A – Prong 1, that math equation amounts to an abstract idea under 2019 PEG.
Claim 1 recites the additional limitations (a), (e) and (g). None of these additional limitations/elements makes the claim significantly more than the abstract idea. In particular, intended practices of HPLC analysis and standard curve technique for quantitative analytical measurements applied to working solutions with different concentrations of either a reference (calibration) compound or a target compound to be tested are all well-known in the relevant industry (see the prior art cited in section 9 below).
As such, the claim does not recite any additional limitation/element that can be treated as “significantly more” or an “inventive concept”. See MPEP 2106.05.
The claim is therefore ineligible under 35 USC 101.
The dependent claims 2-5 inherit attributes of the independent claim 1, but does not add anything which would render the claimed invention a patent eligible application of the abstract idea. The claim merely extends (or narrows) the abstract idea which does not amount for "significant more" because it merely adds details to the algorithm which forms the abstract idea as discussed above.
Hence the claims 1-5 are treated as ineligible subject matter under 35 U.S.C. § 101.
Examiner’s Note
7. While there are related references that discuss mathematically quantifying a plurality of compounds with the same chromophore using a single standard, the prior art of record does not specifically provide teachings for the claimed limitations including:
(d) under a condition that a target compound in a complex sample shares the same chromophore as the standard compound and exhibits a same absorbance as the standard compound at an equal molar concentration, establishing a third standard curve correlating mass concentrations of the target compound with its peak area values according to Equation (5):
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wherein ymeasured represents a peak area of the target compound, xmeasured represents a mass concentration of the target compound, Mr represents a molar mass of the standard compound, Mmeasured represents a molar mass of the target compound, and a and b are parameters;
(f) determining a mass concentration of the target compound in the complex sample by applying the measured peak area obtained in step (e) to the third standard curve.
It is these limitations, as they are claimed in the combination recited in independent claim 1, that would make the pending claims 1-5 of the present application distinguish over the prior art of record.
Conclusion
8. 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 extension fee 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 date of this final action.
Citation of Relevant Prior Art
9. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The closest reference Hu et al. (CN104880517A, machine translation) teaches a method for determining the content of trace ingredients in Chinese drug preparations, comprising: (a) establishing a control fingerprint, wherein the control fingerprint is established using an HPLC technique; (b) assigning a chromatographic peak of the control fingerprint obtained in step (a) and a substance corresponding to the fingerprint peak as a reference; (c) identifying, in combination with the control fingerprint, a target species and its corresponding reference species, wherein the target species and its reference species have similar spectral behavior; (d) establishing a reference standard curve; and (e) estimating the target species content based the reference standard curve (e.g., para. 0005-0022). However, Hu et al. fails to disclose specifically the limitations of the pending claims 1-5 of the present application as identified in section 7 above.
Borman et al. (Single Calibrant Quantification with HPLC — Fact or Fantasy) discloses techniques of HPLC detectors utilized to provide reliable quantitative analytical measurements. Borman et al. fails to disclose specifically the limitations of the pending claims 1-5 of the present application as identified in section 7 above.
QUILLIAM (US 20170102367 A1) discloses a liquid chromatography method for identifying an analyte of interest. QUILLIAM fails to disclose specifically the limitations of the pending claims 1-5 of the present application as identified in section 7 above.
Kaplan et al. (US 20110206772 A1) discloses a technique of establishing a standard curve correlating mass concentrations of a compound with the corresponding peak area values (para. 0127). Kaplan fails to disclose specifically the limitations of the pending claims 1-5 of the present application as identified in section 7 above.
Contact Information
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIUQIN SUN whose telephone number is (571)272-2280. The examiner can normally be reached 9:30am-6:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelby A. Turner can be reached on (571) 272-6334. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/X.S/Examiner, Art Unit 2857
/SHELBY A TURNER/Supervisory Patent Examiner, Art Unit 2857
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