DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 3 and 5-14 are pending and under examination.
35 USC § 112(a) rejections withdrawn
The rejection of claim 3 under 35 U.S.C. 112(a) is withdrawn in view of Applicant’s arguments and amendments to claim 1.
35 USC § 103 rejections withdrawn
The rejection of claims 1, 3 and 5-13 under 35 U.S.C. 103 as being unpatentable over McDevitt et al (US 2014/0235487, published 21 August 2014) in view of Kelpsch et al (Anatomical Rec, 301:1999-2013, 2018) are withdrawn in view of Applicant’s arguments and amendments to claim 1.
35 USC § 101 rejections maintained
The rejections of claims 1, 3 and 5-14 as not being directed to patent eligible subject matter under 35 USC § 101 are maintained.
Applicants state that they have amended claim 1 to recite, in part, treating the subject identified with the carcinoma, lesion, or dysplasia with a cancer treatment regimen based on the identification. Applicant argues that present claim 1 recites methods of assessing and treating disease in a subject through the identification of the percent of mature squamous cells that express nuclear actin in the sample. Applicant argues that the judicial exception is integrated into a practical application of evaluating a sample of a subject for the percent of mature squamous cells that express nuclear actin to assess the presence and severity of a carcinoma, lesion, or dysplasia in the subject and further treating the subject based on the identification of the carcinoma, lesion, or dysplasia. Applicant argues that similar to the claims at issue in Vanda, present claim 1 specifically recites the application of the analysis being made to assess and treat disease
Applicant’s argument has been considered but is not persuasive. Claim 1 in Vanda is drawn to a method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of: determining whether the patient is a CYP2D6 poor metabolizer by: obtaining or having obtained a biological sample from the patient; and performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up
to 24 mg/day, wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day. The Court stated that asserted claims depend upon laws of nature, an association between genetic polymorphisms in the CYP2D6 locus, corresponding increases in the concentrations of iloperidone or its metabolites, and the effect of such increases in concentrations on corrected QT (QTc). The issue was whether the claims incorporate some additional step sufficient to transform the
claims, making them valid duration relative to baseline. The Court found it persuasive that the dosage step in the '610 Patent does not apply to all patients, but only a specific patient population based upon their genetic composition. The dosage step requires applying genetic tests in a highly specified way. Moreover, the process of using this genetic test to inform the dosage adjustment recited in the claims was not routine or conventional and amounted to more than a mere instruction to apply a natural relationship. The Court stated that this combination of elements is sufficient to ensure that the claims amount to significantly more than just a natural law.
In the present claims, as stated previously, there are judicial exceptions. The question then becomes whether the claims incorporate some additional step sufficient to transform the claims. The present claims do not incorporate some additional step sufficient to transform the claims. The limitation, “treating the subject identified with the carcinoma, lesion, or dysplasia with a cancer treatment regimen based on the identification” is not sufficient to transform the claim to amount to significantly more than just a natural law. Just inserting a generic treatment limitation does not transform that patent-ineligible claim into a patent-eligible claim. The Subject Matter Eligibility Examples on page 48 indicates that “The claimed steps and particularly recitation of a particular treatment (administration of an effective amount of anti-TNF antibodies) in step d amounts to more than merely diagnosing a patient with julitis and instructing a doctor to generically “treat it”. The Guidelines further indicate that “Treatment step d is integrated into the claim as a whole (which ensures that patients with julitis will be accurately diagnosed and properly treated with anti-TNF antibodies. The limitation, ““treating the subject identified with the carcinoma, lesion, or dysplasia with a cancer treatment regimen based on the identification”, or both has been interpreted as determining a cellular phenotype characteristic that is a percent of mature
squamous cells of the sample that express nuclear actin based upon the identified cellular phenotype of the cells, using the cellular phenotype characteristic to assess a presence or severity of a carcinoma, lesion, or dysplasia in the subject, wherein the carcinoma, lesion, or dysplasia is associated with oral cancer, lung cancer, esophageal cancer, colorectal cancer, cervical cancer, skin cancer, liver cancer, kidney cancer, or breast cancer and treating it. Thus, unlike in Vanda where the patient receives a specific treatment, iloperidone, the present claims just list a generic cancer treatment based on what cancer the subject is assessed as having a carcinoma, lesion, or dysplasia. Unlike in Vanda there is not a specific relationship between assessing a patient as having one of nine cancers and the generic cancer treatment.
35 USC § 112(a) rejections maintained
The rejection of claims 1 and 5-14 under 35 U.S.C. 112(a) because the specification, while being enabling for a method of assessing an oral disease in a subject comprising identifying at least one cellular phenotype of one or more cells in a sample of the subject, determining a cellular phenotype characteristic that is a percent of mature squamous cells of the sample that express nuclear actin based upon the identified cellular phenotype of the cells and using the cellular phenotype characteristic to assess a presence or severity of oral disease in the subject, does not reasonably provide enablement for a method of assessing any disease in a subject comprising: identifying at least one cellular phenotype of one or more cells in a sample of the subject, determining a cellular phenotype characteristic that is a percent of mature squamous cells of the sample that express nuclear actin based upon the identified cellular phenotype of the cells and using the cellular phenotype characteristic to assess a presence or severity of any carcinoma, lesion, or dysplasia in the subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Applicants state that they have amended claim 1 to recite, in part, wherein the
carcinoma, lesion, or dysplasia is associated with oral cancer, lung cancer, esophageal cancer, colorectal cancer, cervical cancer, skin cancer, liver cancer, kidney cancer, or breast cancer. Applicants argue that a skilled artisan would understand that carcinomas, lesions, or dysplasias related to oral cancer, lung cancer, esophageal cancer, colorectal cancer, cervical cancer, skin cancer, liver cancer, kidney cancer, or breast cancer share certain aspects that would allow a skilled artisan to practice the methods of amended claim 1 without undue experimentation. Applicants argue that a skilled artisan would appreciate that the expression and localization of actin in carcinoma cells related to any particular cancer, at least in part due to the epithelial nature of carcinomas and known shared cytoskeletal characteristics among epithelial cells, would be applicable across different carcinomas.
Applicants further argue that a skilled artisan would appreciate that the epithelial
nature of carcinomas, lesions, or dysplasias associated with oral cancer, lung cancer,
esophageal cancer, colorectal cancer, cervical cancer, skin cancer, liver cancer, kidney
cancer, or breast cancer, as recited in claim 1, is a general quality that gives this class shared cytoskeletal characteristics and therefore a shared peculiar fitness for the diagnosis and treatment of disease based at least in part on actin localization and expression as in amended claim 1.
Applicant’s arguments have been considered but are not persuasive. As stated in MPEP 2164.03, in applications directed to inventions in arts such as most chemical reactions and physiological activity where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. The standard is whether a skilled person could determine which embodiments that were conceived, but not yet made, would be inoperative or operative with expenditure of no more effort than is normally required in the art.
It is well known that squamous cell carcinomas of the breast, colon, liver and kidney are extremely rare. It is not clear how one could assess and treat a carcinomas including breast, colon, liver and kidney carcinomas by measuring the percent of mature squamous cells of the sample that express nuclear actin ranging between 10% and 100%.
Furthermore, it is not even clear whether squamous cell carcinomas from different tissues would have the same phenotype as squamous cell oral cancer. As discussed previously, the specification only discloses that new signatures of oral epithelial dysplasia and oral squamous cell carcinoma identified through this cytology-on-a-chip and machine learning approach have biological association with the disease and have the potential to serve as novel tests for rapid and effective potentially malignant oral lesion screening and surveillance of the entire spectrum of oral epithelial dysplasia and oral squamous cell carcinoma in multiple care settings (page 62 lines 11-15). However, the specification does not disclose any evidence that measuring the percent of mature squamous cells of the sample that express nuclear actin may be used to assess the presence or severity of any carcinoma, lesion, or dysplasia in the subject.
Summary
Claims 1, 3 and 5-14 stand rejected
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/MARK HALVORSON/Primary Examiner, Art Unit 1646