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 .
Claim Interpretation
2. 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.
3. 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an acquisition unit”, and “a computing unit” in claims 1-9 and 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
4. 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.
5. Claims 1-12 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 1-12 are directed to an abstract idea of identifying a target component using a peak detection algorithm.
Specifically, representative claim 12 recites:
A detection system comprising:
a chromatograph; and
a detection device that detects an anomaly in an identification result of a target component, wherein the detection device includes:
(b1) an acquisition unit that acquires a plurality of pieces of detection data detected by a chromatograph, the plurality of pieces of detection data corresponding, on a one-to-one basis, to a plurality of samples; and
(b2) a computing unit that processes the plurality of pieces of detection data acquired by the acquisition unit, and the computing unit
acquires an identification result indicating that peak information regarding signal intensity extracted from each of the plurality of pieces of detection data is identified as peak information regarding signal intensity corresponding to the target component, and
detects, in a case where there is outlier peak information among a plurality of pieces of the peak information identified for respective ones of the plurality of pieces of detection data, that an identification result corresponding to the outlier peak information is anomalous.
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.
System/Apparatus
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 (c) and (d) recited in the bolded portion encompasses mathematical concepts and/or calculations, namely a series of calculations leading to one or more numerical results or answers (see Specification, US 20250027915 A1, [0044]-[0045], [0062], [0066]-[0069]), which also encompasses mental processes, i.e. data manipulation, observation, analyses and judgment, 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
Nothing in the bolded portion precludes this limitation from practically being performed in the mind and/or with the aid of pen/paper. Therefore, the bolded portion of instant claim 12, reciting a series of mathematical concepts and mental process, amounts to an abstract idea falling within a combination of the “Mathematical Concepts” and “Mental Process” groupings of Abstract Ideas defined by the 2019 PEG.
2A - Prong 2: Integrated into a Practical Application?
No.
Besides the abstract idea, claim 12 recites the additional elements of the chromatograph and the detection device at a high level of generality. Under the BRI, the claimed chromatograph encompasses a conventional tool or means for acquiring the data/information necessary for performing the abstract idea. The claim does not provide details whatsoever of how the chromatograph operates as a particular machine or manufacture that is integral to the claim. The detection device comprising the limitations of (b1) and (b2) represents no more than mere instructions to apply the judicial exception on a general-purpose computer. According to the MPEP 2106.04(a)(2), if a claim limitation, under its broadest reasonable interpretation, covers mental processes except for the mention of generic computer components performing computing activities via basic function of the computer, then the claim is likely considered to be directed to an ineligible abstract idea, as it essentially describes a mental process that could be performed by a human without the computer components adding any significant practical application beyond the abstract concept itself. Thus, the recitation of the chromatograph and the detection device in claim 12 does not integrate the identified judicial exception into a practical application.
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. Instead, based on the above considerations, the claim would tend to monopolize the algorithm across a wide range of applications.
2B: Claim provides an Inventive Concept?
No.
Focusing on what the inventors have invented exactly, it is considered that the “core” of pending claim 12 is directed to an abstract idea of identifying a target component using a peak detection algorithm. As discussed in Step 2A Prong Two above, each or the combination of the additional limitations in the claim amounts to no more than an intended use of conventional chromatography technology for gathering the data/information necessary for performing the abstract idea and/or mere instructions to apply the exception using generic computer components.
At Step 2B, the evaluation of the insignificant extra-solution activities takes into account whether or not the extra-solution activity is well-known. Here, under the BRI, all the additional elements as recited in the limitations (a) and (b) of instant claim 12 are considered well-understood, routine, or conventional. The claim does not recite any additional 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.
Claims 1, 19 and 11 are rejected under 35 U.S.C. § 101 for the same reason as for claim 12.
Under the BRI, the limitations of claims 2 and 4 relating to the display device are treated as insignificant post-solution activities. The courts have decided that presenting generated data as well-understood, routine, conventional activity when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (MPEP § 2106.05(d)(II) other types of activities example iv. presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93).
Claim 3 recites “wherein the computing unit acquires a measure of central tendency on a basis of other peak information different from the outlier peak information, and replaces the outlier peak information with the measure of central tendency”. Under the BRI, these limitations encompass mathematical calculations, which also encompass mental processes, i.e. data manipulation, observation, analyses and judgment, that can be performed in the human mind or by a human using a pen and paper.
Claim 9 recites “wherein the plurality of samples include a standard sample used to generate information for identifying the target component from the peak information”. Under the BRI, this limitation encompasses merely data characterization of the identified abstract idea which can be viewed as an attempt to generally link the use of the judicial exception to the relevant technological environment or field of use.
The dependent claims 5-8 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.
Claims 1-12 are therefore treated as ineligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
6. 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; or
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claims 1-7 and 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elnaggar et al. (US 20250003922 A1, which is US-PGPUB of WO 2023059595 A1 published on 2023-04-13).
Regarding claims 1, 10 and 11, Elnaggar discloses a device and a method for practicing the device (para. 0204), including a computer-readable medium comprising instructions which when executed by a computer cause the computer to carry out the method (para. 0016, 0029), the device comprising:
an acquisition unit that acquires a plurality of pieces of detection data detected by a chromatograph (para. 0071: “…capillary electrokinetic chromatography, micellar electrokinetic chromatography, … or any other separation technique that separates components of an analyte mixture by differential velocity”; see also para. 0087, 0091, 0098, 0243), the plurality of pieces of detection data corresponding, on a one-to-one basis, to a plurality of samples (para. 0015, 0050, 0068: “analytes are imaged during separation in capillaries or on microfluidic devices, and molecular weight or mass-to-charge ratio is measured in a mass spectrometer post separation”; see also para. 0071, 0079, 0085, 0087, 0121: “acquire image(s) of a separation channel (or other portion of a microfluidic device)”; and a computing unit that processes the plurality of pieces of detection data acquired by the acquisition unit (para. 0121), wherein the computing unit:
acquires an identification result indicating that peak information regarding signal intensity extracted from each of the plurality of pieces of detection data is identified as peak information regarding signal intensity corresponding to a target component (para. 0010; “the extracted chronogram is a base peak ion (BPI) intensity plot or a multi-dimensional plot”; para. 0079: “software for processing images and determining the position(s) of one or more pI standards or analyte peaks in a separation channel while the separation is being performed, after the separation is complete, or after mobilization of the pI standards and analyte peaks towards the electrospray tip”; para. 0238: “While mobilization occurs, the software continues to capture absorbance images, and identifies peaks …”; see also discussion of Fig. 18), and
detects, in a case where there is outlier peak information (with the BRI to the claim, information of the correlation between the imaged analyte peaks and the mass spectrometer data which identifies one or more particular analyte species reads on “where there is outlier peak information”; see para. 0078: “the correlation of charge variant peaks with mass spectrum data may allow confirmation of post-translational modifications or other protein or peptide modification. …”; para .0136: “correlating the IEF data and MS data may be particularly useful in identifying or distinguishing one or more analyte species having a similar property (e.g., with the same charge or isoelectric point, or with the same mass) and/or having a different property”) among a plurality of pieces of the peak information identified for respective ones of the plurality of pieces of detection data, that an identification result corresponding to the outlier peak information is anomalous (para. 0013: “the at least one integrated plot is a pI and mass resolved intensity plot for all peaks in the third data set and/or second data set. … an identity of the one or more analytes in the pI and mass resolved intensity plot is determined …”; para. 0136: “the correlation of the IEF and MS data may be used to distinguish the two molecules (e.g., identifying them as different species or isoforms)”; para. 0222: “Other applications may include, but are not limited to, analysis of environmental pollutants, pesticides, small molecules, metabolites, peptides, post-translational modifications …”; see also para. 0186, 0210, 0251).
Regarding claim 2, Elnaggar discloses: wherein the computing unit causes a display device to display (e.g., Figs. 25 and 26) the outlier peak information in an emphasized manner (e.g., “an ion signal intensity as a function of mass to charge ratio (m/z) as a function of time”) as compared to other peak information different from the outlier peak information (para. 0150-0151).
Regarding claims 3 and 4, Elnaggar discloses: wherein the computing unit acquires a measure of central tendency on a basis of other peak information different from the outlier peak information (see the portion of Fig. 26 before the integration of the five paired points), and replaces the outlier peak information with the measure of central tendency (see the portion of Fig. 26 after the integration of the five paired points); wherein the computing unit causes a display device to display, in a recognizable manner, both the peak information before the outlier peak information is replaced with the measure of central tendency and the peak information after the outlier peak information is replaced with the measure of central tendency (Fig. 26).
Regarding claim 5, Elnaggar discloses: wherein the peak information includes a retention time when signal intensity is at a maximum (para. 0130: “the tracking of one or more analyte bands from one image to the next in a series of images may be used to distinguish between several separated analyte bands, and to refine the velocity calculation (e.g., through averaging the velocity values calculated from several pairs of images in the series)”; para. 0100, 0158).
Regarding claim 6, Elnaggar discloses: wherein the peak information includes at least one of a retention time when signal intensity starts to rise, a retention time when signal intensity stops falling, or a position of a baseline (see discussion of Figs. 17A and 17B).
Regarding claim 7, Elnaggar discloses: wherein the computing unit corrects in advance a retention time included in each of the plurality of pieces of detection data (para. 0072; note, by inherency, adjusting those operating parameters must affect the retention time included in each of the plurality of pieces of detection data as claimed).
Regarding claim 9, Elnaggar discloses: wherein the plurality of samples include a standard sample used to generate information for identifying the target component from the peak information (para. 0156: “to store a plurality of reference values (e.g., expected or known charge and/or mass changes for different post-translational modifications). These stored reference values may subsequently be used by one or more processors to match IEF and MS data to determine or identify a post-translational modification in an analyte peak”; para. 0173).
Regarding claim 12, Elnaggar discloses a detection system (para. 0204) comprising: a chromatograph (para. 0071, 0087, 0091, 0098, 0243; see also discussion of the capillary- and microfluidic-based chemical separation system as shown in Fig. 5); and a detection device (e.g., the computer processor) that detects an anomaly in an identification result of a target component (para. 0222), wherein the detection device includes: an acquisition unit that acquires a plurality of pieces of detection data detected by a chromatograph, the plurality of pieces of detection data corresponding, on a one-to-one basis, to a plurality of samples; and a computing unit that processes the plurality of pieces of detection data acquired by the acquisition unit, and the computing unit acquires an identification result indicating that peak information regarding signal intensity extracted from each of the plurality of pieces of detection data is identified as peak information regarding signal intensity corresponding to the target component, and detects, in a case where there is outlier peak information among a plurality of pieces of the peak information identified for respective ones of the plurality of pieces of detection data, that an identification result corresponding to the outlier peak information is anomalous (see discussion of claims 1, 10 and 22 as set forth above).
Claim Rejections - 35 USC § 103
8. 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.
9. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Elnaggar et al. in view of Hsiung et al. (US 12590889 B2).
Regarding claim 8, Elnaggar does not mention: wherein the detection device determines whether or not there is the outlier peak information among the plurality of pieces of the peak information using a Hotelling's T-squared method.
Hsiung discloses an outlier sample detection device (Abstract), wherein the detection device determines whether or not there is outlier spectroscopic measurement information among a plurality of pieces of spectroscopic measurements using a Hotelling's T-squared method (col. 23, lines 23-28).
It is deemed that the Hotelling's T-squared method, as a multivariate statistical test that generalizes the univariate Student’s t-test to compare the means of two groups when multiple dependent variables are measured simultaneously, is well-known in the art. As being motivated by Hsiung, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate such well-known statistical test tool into Elnaggar and apply it to determine whether or not there is the outlier peak information among the plurality of pieces of the peak information. The skilled person in the relevant field would conceive and apply such modification as an intended use of known technology without needing inventive skill but depending on practical considerations and according to the dictates of the circumstances. It has been held that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963).
Citation of Relevant Prior Art
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
1) US 10209217 B2 -- Devices And Methods For Sample Characterization
2) US 20230178348 A1 -- CHROMATOGRAPH MASS SPECTROMETRY DATA PROCESSING METHOD, CHROMATOGRAPH MASS SPECTROMETER, AND CHROMATOGRAPH MASS SPECTROMETRY DATA PROCESSING PROGRAM
3) US 20170284984 A1 -- METHOD AND SYSTEM FOR DETECTING PESTICIDE RESIDUE IN ARGICULTURAL PRODUCTS USING MASS SPECTROMETRY IMAGING ANALYSIS
Contact Information
11. 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/X.S/Examiner, Art Unit 2857
/MOHAMMAD K ISLAM/Primary Examiner, Art Unit 2857
Prosecution Insights