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 .
DETAILED ACTION
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 1-8 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.
Specifically, representative Claim 1 recites:
“A computer-implemented method for determining a probability of presence of a cancer condition comprising: determining a concentration of sialic acid in a saliva sample of a person using a sialic acid concentration analysis device; comparing the determined concentration of sialic acid with a database relating sialic acid concentrations with cancer conditions; and determining and outputting a probability of presence of a particular cancer condition based on the comparison of the determined concentration of sialic acid with a database relating sialic acid concentrations with cancer conditions.”
The claim limitations in the abstract idea have been highlighted in bold above; the remaining limitations are “additional elements”.
Under the Step 1 of the eligibility analysis, we determine whether the claims are to a statutory category by considering whether the claimed subject matter falls within the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: Process, machine, manufacture, or composition of matter. The above claim is considered to be in a statutory category (process).
Under the Step 2A, Prong One, we consider whether the claim recites a judicial exception (abstract idea). In the above claim, the highlighted portion constitutes an abstract idea because, under a broadest reasonable interpretation, it recites limitations that fall into/recite an abstract idea exceptions. Specifically, under the 2019 Revised Patent Subject matter Eligibility Guidance, it falls into the groupings of subject matter that covers mathematical concepts - mathematical relationships, mathematical formulas or equations, mathematical calculations and mental processes – concepts performed in the human mind including an observation, evaluation, judgement, and/or opinion.
For example, the step of “determining and outputting a probability of presence of a particular cancer condition” is treated as belonging to the mathematical concepts grouping while the steps of “comparing the determined concentration of sialic acid with a database relating sialic acid concentrations with cancer conditions; and … based on the comparison of the determined concentration of sialic acid with a database relating sialic acid concentrations with cancer conditions” are treated as belonging to mental process grouping. These mental steps represent a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. In the context of this claim, it encompasses a user manually evaluating the concentrations and comparing with the database concentrations corresponding to cancer condition and, based on the comparison, relating it to particular cancer condition probabilities (i.e. “observation/evaluation/judgement” mental steps). The latter step, under the BRI, alternatively/additionally is treated as mathematical relationship step (MPEP 2106.04.II: “construing the claims in accordance with their broadest reasonable interpretation”).
Similar limitations comprise the abstract ideas of Claim 5.
Next, under the Step 2A, Prong Two, we consider whether the above claims that recites a judicial exception are integrated into a practical application.
The above claims comprise the following additional elements:
In Claim 1: A computer-implemented method for determining a probability of presence of a cancer condition comprising: determining a concentration of sialic acid in a saliva sample of a person using a sialic acid concentration analysis device; outputting step;
In Claim 5: A system for determining a probability of presence of a cancer condition comprising: a sialic acid concentration analysis device adapted to determine a concentration of sialic acid in a saliva sample of a person; a computer system comprising a processor, memory accessible by the processor, and program instruction and data stored in the memory whereby the computer system is adapted to: control the sialic acid concentration analysis device so as to obtain the concentration of sialic acid; outputting step.
The additional elements in the preambles are recited in generality and represent insignificant extra-solution activity (field-of-use limitations) that is not meaningful to indicate a practical application.
The additional elements in the claims such as a computer-implemented method (Claim 1) and a sialic acid concentration analysis device adapted to determine a concentration of sialic acid in a saliva sample of a person; a computer system comprising a processor, memory accessible by the processor, and program instruction and data stored in the memory whereby the computer system is adapted to: control the sialic acid concentration analysis device (Claim 5) are examples of generic computer equipment (components) that are generally recited and not meaningful and, therefore, are not qualified as particular machines to indicate a practical application. The limitations that generically recite determining a concentration of sialic acid in a saliva sample of a person using a sialic acid concentration analysis device (Claim 1) and obtain(ing) the condensation of sialic acid also using a sialic acid concentration analysis device (Claim 5) represent insignificant extra-solution activity of mere data gathering. According to the October update on 2019 SME Guidance such steps are “performed in order to gather data for the mental analysis step, and is a necessary precursor for all uses of the recited exception. It is thus extra-solution activity, and does not integrate the judicial exception into a practical application”.
Therefore, the claims are directed to a judicial exception and require further analysis under the Step 2B.
However, the above claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B analysis) because these additional elements/steps are well-understood and conventional in the relevant art based on the prior art of record.
The independent claims, therefore, are not patent eligible.
With regards to the dependent claims, claims 2-4 and 6-8 provide additional features/steps which are part of an expanded abstract idea of the independent claims (additionally comprising abstract idea steps) and, therefore, these claims are not eligible without meaningful additional elements that reflect a practical application and/or additional elements that qualify for significantly more for substantially similar reasons as discussed with regards to Claim 1.
For example, additional elements in Claims 2-4 and 6-8 (using a spectrophotometer, Roman spectrometer, and the device being an electrochemical sensor) are all recited in generality and not meaningful to indicate a practical application and/or qualify for significantly more.
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 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.
Claims 1, 3, 5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ekaterina Vinogradova et al. (US 20180238805), hereinafter ‘Vinogradova’.
With regards to Claim 1, Vinogradova discloses
A method for determining a probability of presence of a cancer condition (The present invention generally relates to a system and method of using surface enhanced Raman scattering for detection of sialic acid levels in subjects with cancer [0002]; any SA concentration determined by a SERS-AgNPs test as described in this report, above 7 mg/dl, may indicate with high probability the presence of breast cancer [0091]) comprising:
determining a concentration of sialic acid in a saliva sample of a person using a sialic acid concentration analysis device (aspects of the methods can be used as a diagnostic tool to detect and monitor sialic acid in body fluids (such as saliva and blood) of breast cancer patients [0011]; Comparison between the SERS of sialic acid at concentrations 5, 10, 15 and 20 mg/dl and that of the SA from saliva in six breast cancer patients [0039]; the present invention provides kits and systems for use in monitoring the level of sialic acid in an individual …a device is used to take readings and measure the sialic acid levels in a sample. In some embodiments, an entire system is provided that comprises a sensor, a detection device, and cit-Ag nanoparticles. Other kits may supply the one or more of: (i) reagents to form the cit-AG nanoparticles, (ii) the cit-Ag nanoparticles, (iii) sample processing reagents, (iv) sampling device (e.g., cotton swab), and, (v) controls or standards for comparison or calibration [0058]);
comparing the determined concentration of sialic acid with data relating sialic acid concentrations with cancer conditions (In FIG. 12 a similar comparison between the SERS of pure SA at concentrations 5, 10, 15 and 20 mg/dl and that of the SA from saliva in six breast cancer patients is shown. Now in contrast to the case for the SERS from healthy individuals, it may be appreciated that the SA concentrations in the saliva of these sick patients have values between 10 and 20 mg/dl, instead of values smaller than 5 mg/dl, for the healthy women [0088]; and
determining and outputting a probability of presence of a particular cancer condition based on the comparison of the determined concentration of sialic acid with the data relating sialic acid concentrations with cancer conditions (In FIG. 13 a plot of the resultant frequencies for SA concentrations in intervals of 0.5 mg/dl is shown for both control individuals and for all breast cancer patients irrespective of the diagnosed cancer stage … any SA concentration determined by a SERS-AgNPs test as described in this report, above 7 mg/dl, may indicate with high probability the presence of breast cancer [0091]; the inventors have established that SERS on Ag-NPs provides a reliable, easily reproducible, test to measure the concentration of SA dissolved in a fluid. As the SA concentration in the human fluids increase significantly during a malignant process, the same SERS procedure can be used immediately to measure SA levels in women, in particular in the saliva. The inventors have performed a study with 140 breast cancer patients and 104 control individuals. The mean SA concentration in this study for saliva of the control group was 3.5±1.0 mg/dl and that for the breast cancer patients was a mean of 17.0±7.5 mg/dl. The SA test showed a sensitivity of 92%, specificity of 99.8% and a coincident precision of 99.8%. Based on this data it is suggested that an upper limit to consider a deviation of normality a SA concentration above 7 mg/dl in the saliva. Larger SA levels may indicate with high probability the presence of a breast cancer affection, or of other neoplasia, requiring further medical examination and possible treatment [0102]).
However, Vinogradova does not explicitly disclose that her method is computer-implemented and that the comparison takes place against a database relating sialic acid concentrations with cancer conditions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vinogradova to use a computer-implemented method for determining a probability of presence of a cancer condition that would simplify/automate calculations as discussed in Vinogradova ([0033], [0060], [0069], [0089]) and/or follow-up comparisons of actual concentration of sialic acid with data relating sialic acid concentrations with cancer conditions stored in a database format as opposed to manual comparisons using other than database-stored data such as graphs, look-up tables, etc. corresponding to normal/health vs. abnormal/cancer conditions as known in the art and also as a matter of a design preference, since the applicant has not disclosed that using a computerized method or specifically comparing with a database solve any stated problem or are for any particular purposes, and it appears that the invention would perform equally well without these particular features as known in the art.
With regards to Claim 3, Vinogradova further discloses wherein the sialic acid concentration analysis device comprises a Raman spectrometer (The present invention generally relates to a system and method of using surface enhanced Raman scattering for detection of sialic acid levels in subjects with cancer [0002]).
With regards to Claim 5, Vinogradova as modified discloses the claim limitations as discussed above with regards to Claim 1.
In addition, Vinogradova discloses DFT calculations using a program [0070] which implies using a computer (system) and program instructions stored in a memory.
With regards to Claim 7, Vinogradova as modified discloses the claim limitations as discussed above with regards to Claims 5 and 3.
Claims 2, 4, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Vinogradova in view of Se Hwan Pack et al. (US 20110097740), hereinafter ‘Pack’.
With regards to Claims 2 and 4, Vinogradova is silent on wherein the sialic acid concentration analysis device comprises a spectrophotometer and wherein the sialic acid concentration analysis device comprises an electrochemical sensor, respectively.
Pack discloses using a spectrophotometer and electrochemical sensor [0084].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vinogradove in view of Pack to use a spectrophotometer and electrochemical sensor-tools known in the art to detect an analyte in a sample (Pack, Absract).
With regards to Claims 6 and 8, Vinogradova in view of Pack discloses the claim limitations as discussed above with regards to Claims 5 and Claims 2 and 4.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent Application Patent No. 19/335575. Although the claims at issue are not identical, they are not patentably distinct from each other because it appears that independent claims 1 and 5 of US Patent Application No. 19/335575 are narrower than the instant independent claims 1 and 5. Therefore, they disclose the features of the latter claims. The instant application’s dependent claims 2-4 and 6-8 are also disclosed by the relevant claims 2-4 and 6-8 of U.S. Patent Application 19/335575.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nonda Katopodis et al., “Lipid-associated Sialic Acid Test for the Detection of Human Cancer”, CANCER RESEARCH 42, 5270-5275, December 1982, discloses lipid-associated sialic acid concentrations were found to be significantly increased in all groups of cancer patients as compared to both those with benign diseases and normal controls.
Paul C. Danny et al. (US 20030040009) discloses assessing the risk of a disease using salivary analysis (sialic acid concentration in saliva).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER SATANOVSKY whose telephone number is (571)270-5819. The examiner can normally be reached on M-F: 9 am-5 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Catherine Rastovski can be reached on (571) 270-0349. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER SATANOVSKY/
Primary Examiner, Art Unit 2857
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