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 .
Office Action Overview
Claim Status
Canceled:
5, 15, 19-21, 23, 26-29, and 31-33
Pending:
1-4, 6-14, 16-18, 22, 24, 25, and 30
Withdrawn:
none
Examined:
1-4, 6-14, 16-18, 22, 24, 25, and 30
Independent:
1 and 30
Amended:
1-4, 6-14, 16-18, 22, 24, 25, and 30
New:
none
Allowable:
none
Objected to:
25
Rejections applied
Abbreviations
X
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
X
102, 103
JE
Judicial Exception
X
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed in the 01/20/2023 filing receipt, this application is a 371 of PCT/GB2019/053245, filed 11/15/2019. At this point in examination, all claims have been interpreted as being accorded this priority date.
Claim Objections
Claim 25 is objected to because of the following informalities: Claim 25 line 3-4 is missing a second instance of the term "of" in the recitation: "and/or a portion of a single cell including cytoplasm." To recite consistent claim language, this should be amended to recite "and/or of a portion of a single cell including cytoplasm." 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.
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.
Claims 1-4, 6-14, 16-18, 22, 24, 25, and 30 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate.
In claims 1 and 30, the connection is unclear between the singular "feature" and plural "features" in the recitations "determining a feature of interest from each spectrum of the plurality of spectra" and "determining a distribution of the features of interest." As recited, there is an embodiment where only one feature of interest is determined from the plurality of spectra, and therefore it is not clear how a distribution of features (plural) of interest would be determined when only one feature of interest had been determined in the previous step. For examination purposes, it is interpreted that one distribution of one feature (singular) of interest will be determined.
The phrase "in case" is unclear in claims 2, 4, 10, and 13 as follows (bold emphasis added):
• "… lung disease is diagnosed in case the distribution is asymmetric.…" (claim 2, line 2)
• "… the distribution is asymmetric in case the ratio.…" (claim 4, line 2)
• "… lung disease is diagnosed in case the distribution.…" (claim 10, line 2)
• "… lung disease is diagnosed in case the standard deviation.…" (claim 13, line 3-4)
It is not clear if the phrase "in case" is meant to mean "if", or is meant to mean "when", or is meant to mean something else. However, taking claim 2 as an example, amending "in case" to recite "if" or "when" would include embodiments in which the distribution is not asymmetric, and therefore lung disease would not be diagnosed. The claim 2 rejection might be overcome by, for example, possibly amending claim 2 to recite an active step of determining the distribution to be asymmetric, and subsequently reciting a step for diagnosing lung disease based on the determination of an asymmetric distribution. An amendment of claim 2 that might overcome this 112(b) rejection might possibly recite something similar to …"wherein diagnosing lung disease comprises determining the distribution to be asymmetric; and diagnosing lung disease based on the asymmetric distribution." The other instances of "in case" in claims 4, 10, and 13 should possibly be amended similarly.
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.
Matter belonging to no statutory category – Claims 1-4, 6-14, 16-18, 22, 24, and 25:
Claims 1-4, 6-14, 16-18, 22, 24, and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 1 is a "computer readable medium carrying a computer program comprising code," which is not, in all embodiments within a BRI, interpreted as belonging to any category listed in 101. In a BRI, the claim reads on data and/or software comprising no structure other than data and/or software. The also claim reads on transitory propagating signals which are not proper patentable subject matter because it does not fit within any of the four statutory categories of invention (In re Nuijten, Federal. Circuit, 2006).
None of the dependent claims remedy this rejection.
As appropriate, this rejection can be overcome by, for example, amending claim 1 to recite, e.g., "non-transitory computer readable medium carrying a computer program comprising code."
Matter reciting judicial exceptions - Claims 1-4, 6-14, 16-18, 22, 24, 25 and 30:
Claims 1-4, 6-14, 16-18, 22, 24, 25, and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 details the following framework to analyze Subject Matter Eligibility:
• Step 1: Are the claims directed to a category of statutory subject matter (a process, machine, manufacture, or composition of matter)? (see MPEP § 2106.03)
• Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon? (see MPEP § 2106.04(a)). Note, the MPEP at 2106.04(a)(2) & 2106.04(b) further explains that abstract ideas and laws of nature are defined as:
• mathematical concepts, (mathematical formulas or equations, mathematical
relationships and mathematical calculations);
• certain methods of organizing human activity (fundamental economic practices
or principles, managing personal behavior or relationships or interactions between
people); and/or
• mental processes (procedures for observing, evaluating, analyzing/ judging and
organizing information).
• laws of nature and natural phenomena are naturally occurring principles/ relations that
are naturally occurring or that do not have markedly different characteristics compared to
what occurs in nature.
• Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application? (see MPEP § 2106.04(d))
• Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? (see MPEP § 2106.05)
Regarding Step 1:
Step 1: NO, regarding claims 1-4, 6-14, 16-18, 22, 24, and 25, as discussed in the preceding 101 rejection; however, for compact examination, claims 1-4, 6-14, 16-18, 22, 24, and 25 will be examined with the expectation that Applicant will amend claim 1 to include "non-transitory" as discussed above.
Step 1: YES, regarding claim 30, as claim 30 is directed to a method, and therefore to a category of statutory subject matter. (See MPEP § 2106.03).
Regarding Step 2A, Prong One:
The claims recite judicial exceptions of abstract ideas in the form of mental processes and mathematical concepts as follows:
• determining a feature of interest from each spectrum (claims 1 and 30)
• determining a distribution of the features (claims 1 and 30)
• diagnosing a lung disease in dependence on the distribution (claims 1 and 30)
• diagnosing a lung disease if distribution is asymmetric (claim 2)
• determining a ratio of outliers to non-outliers (claim 3)
• determining asymmetry based on the ratio (claim 3) and threshold (claim 4)
• determining outliers using a one sided (claim 6) or s two sided (claim 12) boundary
• determining one-sided boundary (claim 7)
• determining an asymmetry measure and asymmetry (claim 8)
• diagnosing lung disease if the distribution spread over a threshold (claim 10)
• determining ratios and a spread above the distribution (claim 11)
• determining standard deviation (claim 13)
Claims which further limit one or more of the abstract ideas above include: Claim 9, which further limits the asymmetry measure; claim 18 further limits the feature; claim 22 further limits the band of interest; and claim 24 further limits the lung disease.
Step 2A Prong One summary: When considering the BRI of claims 1 and 30, the steps of determining a feature of interest, determining a distribution of the feature, and diagnosing lung disease based on the distribution recite abstract ideas of mental processes because the data analysis steps, as recited, could be performed in the human mind, or with pencil and paper. Additionally, the limitations for: determining a distribution; determining a ratio of outliers; determining an asymmetry measure, a skew, a Pearson's skew, and/or a kurtosis; determining a standard deviation; etc., recite inherent mathematical concepts such as those disclosed in Specification throughout pp. 8-10.
Therefore, the claims recite elements that constitute a judicial exception in the form of abstract ideas. (Step 2A, Prong One: Yes.)
Regarding Step 2A, Prong Two:
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). Here at Step 2A, Prong Two, any remaining steps and/or elements not identified as JEs are therefore in addition to the identified JE(s), and are considered additional elements. Because the claims have been interpreted as being directed to judicial exceptions, abstract ideas in this instance, then Step 2A, Prong Two provides that the claims be examined further to determine whether the judicial exception is integrated into a practical application [see MPEP § 2106.04(d)]. A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
MPEP § 2106.04(d)(I) lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
(1) An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
(2) Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
(3) Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
(4) Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
(5) Applying or using 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, as discussed in MPEP § 2106.05(e).
The additional elements recited in the instant claims are as follows:
Additional elements of data gathering, including cells: Claims 1, 17, 25, and 30 recites additional elements of data gathering in the steps for "obtaining a plurality of spectra of a plurality of cells" (or a portion of a single cell, claim 25). Claim 14 recites the cells are from the upper respiratory tract or are buccal cells. Claim 16 recites infrared spectroscopic, Fourier-transform infrared spectroscopic, benchtop spectroscopic, and/or Raman spectroscopic interrogations. Data gathering steps are additional elements which perform functions of inputting, collecting, and outputting the data needed to carry out the abstract idea. These steps are considered insignificant extra-solution activity, and are not sufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed, nor do they provide an improvement to technology [see MPEP 2106.04(d)(I)].
Additional elements of computer components: Claims 1-4, 6-14, 16-18, 22, 24, and 25 recite the additional element of a computer readable medium (CRM). The claims require only generic computer components, which do not improve computer technology, and do not integrate the recited judicial exception into a practical application (see MPEP 2106.04(d)(1) and MPEP 2106.05(f)).
Step 2A Prong Two summary: The claims have been further analyzed with respect to Step 2A, Prong Two, and no additional elements have been found, alone or in combination, that would integrate the judicial exception into a practical application. (Step 2A, Prong Two: No).
Regarding Step 2B:
Because the additional claim elements do not integrate JE (in this case, the abstract ideas) into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are well-understood, routine, and conventional. Those additional elements are as follows:
Additional elements of data gathering, including cells: The additional elements of: data gathering in claims 1, 17, 25, for "obtaining a plurality of spectra of a plurality of cells" (or a portion of a single cell, claim 25); the upper respiratory tract cells or buccal cells of claim 14; and the infrared spectroscopic, Fourier-transform infrared spectroscopic, benchtop spectroscopic, and/or Raman spectroscopic interrogations of claim 16 do not cause the claims to rise to the level of significantly more than the judicial exception. The courts have recognized receiving or transmitting data over a network; and storing and retrieving information in memory; [see MPEP§2106.05(d)(II)], as well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as extra-solution activity.
Additionally, the following references show the additional elements of data gathering, for obtaining spectra from cells, including sputum and/or buccal cells, to be well understood and conventional:
Pahlow, (Applied spectroscopy, vol. 72(1_suppl), pp.52-84 (2018); cited on the attached form PTO-892), presents a review on vibrational spectroscopy and imaging to point-of-care medicine, and shows spectroscopy methods, including Fourier-transform infrared spectroscopic and Raman spectroscopy in lung cancer/tumors (p.55, col.1; p.69, col.1). Pahlow shows Raman spectroscopy in sputum analysis (p.57, col.1); and malignancy associated changes in the buccal mucosa probed by Raman spectroscopy in at risk patient groups from tobacco exposure (p.56, col.2).
Talari, (Applied Spectroscopy Reviews, vol. 52(5), pp.456-506 (2017); cited on the attached form PTO-892), presents a review on advances in Fourier transform infrared (FTIR) spectroscopy of biological tissues. Talari shows FTIR microscopy of lung cancer cells and tissues (p.478 (para.3) through p. 480 (para.2)). Talari discloses FTIR spectra collected from lung cancer patients and healthy controls, showing Spectral bands in the region of 1800 to 950 cm-1 (p.480, para.2).
Therefore the additional elements of data gathering are shown to be routine, well-understood, and conventional in the art, and do not provide an inventive concept needed to amount to significantly more than the judicial exception.
Additional elements of computer components: The additional element of a CRM recited in claims 1-4, 6-14, 16-18, 22, 24, and 25 does not cause the claims to rise to the level of significantly more than the judicial exception; this is a conventional computer component, which does not provide an inventive concept.
Step 2B Summary: All limitations of claims 1-4, 6-14, 16-18, 22, 24, 25, and 30 have been analyzed with respect to Step 2B, and none provides a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception, and thus do not transform the judicial exception into a patent eligible application of the exceptions. (Step2B: NO). Therefore, the claims, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non patent-eligible subject matter.
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 (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 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, 2, 10, 14, 16-18, 22, 24, 25, and 30 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Lewis, (BMC cancer, vol. 10(1):640, pp.1-10 (2010); cited on the 05/24/2022 IDS).
Regarding the limitations:
• obtaining a plurality of spectra produced by spectroscopic interrogations of a plurality of cells (claims 1 and 30)
• the cells are from the upper respiratory tract (claim 14)
• FTIR spectroscopy (claim 16)
• the lung disease is lung cancer (claim 24)
• each spectroscopic interrogation is of a portion of a single cell (claim 25)
Lewis shows FTIR was used to generate absorbance spectra in the frequency region 950 to 1800 cm-1 to establish potential metabolic differences in cells extracted from sputum between 25 lung cancer and 25 normal control samples (p.3, col.2, under "Results").
Regarding the limitations:
• determining a feature of interest from each spectrum of the plurality of spectra (claims 1 and 30)
• the feature is a value at a wavenumber of interest (claim 18)
• the band or wavenumber of interest is in the region of 1050 cm-1 (claim 22)
Lewis shows values for significant wavenumbers of interest, including in the region of 1050cm-1 (p.5, fig.1).
Regarding the limitation:
• determining a distribution of the features of interest (claims 1 and 30)
Lewis teaches normality tests revealed that none of the individual wavenumber absorbance levels followed a normal distribution. Thus, for each wavenumber, median(rather than mean) absorbance levels were used for analysis (p.3, end of col.2).
Regarding the limitations:
• diagnosing a lung disease in dependence on the distribution of features of interest (claims 1 and 30)
Lewis shows determining a set of 92 significant wavenumbers that differentiated cancer sputum from normal sputum. Significant wavenumbers were then ranked according to p-value and plotted against the second derivative median spectra for each group (Figure 2). By analysis of the spectral alignment 6 highly significant wavenumbers were determined that could be associated with prominent and interpretable second derivative peaks in both groups (labelled as A-F in Figure 2). Table 1 summarizes each of these wavenumbers along with the proposed vibrational modes and primary molecular source (p.4, col.2; p.5 fig.2 and table 1).
Regarding the limitation:
• lung disease is diagnosed in case the distribution is asymmetric (claim 2)
• lung disease is diagnosed in case the distribution has a spread above a threshold (claim 10)
Lewis shows normality tests revealed that none of the individual wavenumber absorbance levels followed a normal distribution (p.3, end of col.2, end). Lewis shows a hierarchical cluster analysis (HCA) dendrogram for all 25 cancer and 25 normal sputum is shown in Figure 3. Two large sub-clusters are clearly visible in the dendrogram suggesting that these wavenumbers discriminate (i.e., using a threshold) the two groups with high accuracy (p. 6, col.1, under "Multivariate analysis of sputum FTIR spectra").
Regarding the limitation:
• at least 20 spectra are obtained (claim 17)
Lewis teaches each spectrum represented the average of 256 scans for improved signal to noise ratio (p.3, end of col.1). Lewis teaches FTIR was used to generate absorbance spectra in cells extracted from sputum from 25 lung cancer and 25 normal control samples. (p.3, col.2, under "Results").
Turkmen teaches detecting the introduced outliers for the 20 % contaminated data that include 20 true outliers and 80 true nonoutliers. They used the true positive rate (TPR) and the false positive rate (FPR) for each robust method as a measure of outlier identification accuracy, where TPR (FPR) is the proportion of identified outliers that are among the true outliers (true non-outliers).
Conclusion
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
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/M.A.V./Examiner, Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686