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 .
Specification
The disclosure is objected to because of the following informalities:
Instant specification p. 17 paragraph 3 states “causing 5 a decrease”; this is a typo and should be “causing (5) a decrease”.
Appropriate correction is required.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites “one or more biomarkers listed in Table 1”. While there is a Table 1 in instant specification p. 6 and MPEP 2173.05(s) Reference to Figures or Tables permits such a claim recitation, MPEP 2173.05(s) specifically states (emphasis added) “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)”. Applicant is requested to rewrite claim 5 to list in words the biomarkers of Table 1 instead of referencing to Table 1 because this is not an exceptional circumstance that would make this recitation impractical. It is noted that a claim text search of the entire US patent and patent application database only yielded three examples of claims that recited “listed in Table…”; this lends further credence that the instant claim would not meet the “exceptional circumstances” as described in MPEP 2173.05(s).
Appropriate correction is required.
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.
Independent claim(s) 14, 18 and dependent claims 2-12 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite the collection and analyzing of data. More specifically, independent claims 14 and 18 and their dependents are directed to the mental process (i.e. abstract idea) of collecting and processing health data.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis. The following analysis is similar to example 43 Treating Kidney Disease of Appendix 1 to the October 2019 Update: Subject Matter Eligibility Life Sciences & Data Processing Examples. (https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_app1.pdf)
Step 1: Is the claim(s) to a process, machine, manufacture or composition of matter?
Yes, independent claims 14, 18 and dependents are to a process (method).
Step 2A (Prong 1): Does the claim(s) recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claim(s) recite an abstract idea of data collection and usage. The steps of data collection and usage carried out in Applicant's claims are akin to a mental process because they are the type of calculations (comparing level to reference) that could theoretically be carried out mentally, but are merely implemented using generic collection technology. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology; please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016).
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim(s) does not recite additional elements that integrate the judicial exception into a practical application because the claim(s) indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated, or what the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient. In fact, this limitation is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s (comparing level to reference) outcome into account when deciding which treatment to administer, making the limitation’s inclusion in this claim at best nominal. Like the claims in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 78 (2012), the instant claims tells the relevant audience (doctors) about the mathematical concepts and at most adds a suggestion that the doctors take those laws into account when treating their patients. The instant limitations thus fails to meaningfully limit the claim because it does not require any particular application of the recited calculation, and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, the instant limitations does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, in addition to the relevant discussion in Step 2A (Prong 2) above, please note, as explained in MPEP § 2106.05(I) (A), limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include those listed therein.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim limitations does not require any particular application of the recited calculation and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept.
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.
Independent claim 14, its dependents 2-3, 5-12, and independent claim 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fu (US 20030008407 A1; 1/9/2003; cited in IDS).
Regarding independent claim 14, Fu teaches a method of treating hyperglycemia in a subject ([0039]; 0070]; [0093]), the method comprising:
a) determining the level of one or more biomarkers in a sample obtained from the subject, wherein the level or levels of the one or more biomarkers, or a value derived therefrom, as compared to a reference predicts the likelihood of hyperglycemia in the subject ([0012] “correlate with the condition”; [0014] “baseline”; [0032]; [0039] “hyperglycemia”; [0045]; [0106]; claims 1, 7-8); wherein the one or more biomarkers comprises at least one of cymene, butanol and pentanol ([0079] “1-pentanol”; [0106] “pentanol”), or selecting a subject who is likely to have hyperglycemia, wherein the level or levels of the one or more biomarkers, or a value derived therefrom, in a sample obtained from the subject as compared to a reference predicts that the subject is likely to have hyperglycemia ([0012] “correlate with the condition”; [0014] “baseline”; [0032]; [0039] “hyperglycemia”; [0045]; [0106]; claims 1, 7-8), wherein the one or more biomarkers comprises at least one of cymene, butanol and pentanol ([0079] “1-pentanol”; [0106] “pentanol”) and
b) exposing the subject to a treatment regimen to treat hyperglycemia in the subject ([0045] “treatment”; [0070] “therapy”; [0093] “therapeutic and preventative strategies”).
Regarding claim 2, Fu teaches wherein the sample is a breath sample (Fig. 10; [0012] “gaseous emanations”; [0045] “exhaled breaths”; [0076] “breath”).
Regarding claim 3, Fu teaches wherein the method comprises comparing the level of the one or more biomarkers obtained from the subject to a reference ([0012] “correlate with the condition”; [0014] “baseline”; [0032]; [0039]; [0045]; [0106]; claims 1, 7-8).
Regarding claim 5, Fu teaches wherein the method further comprises determining the level of one or more biomarkers listed in Table 1 (interpreted in light of Table 1 of instant specification p. 6 which lists “pentanol” and “Acetone” amongst others; Fu [0045] “acetone”; [0079] “1-pentanol”; [0106] “pentanol”).
Regarding claim 6, Fu teaches wherein the method further comprises determining the level of at least one of acetone (0045] “acetone”), ethanol, Propane, Carbon monoxide, Ethyl benzene, Xylene, methanol and Isoprene.
Regarding claim 7, Fu teaches wherein the method further comprises determining the level of at least one of Methyl Nitrate, Pentyl nitrate, Toulene, Tridecane, Undecane, Trimethyldecane and Pentane ([0007] “pentane”; [0069] “pentane”).
Regarding claim 8, Fu teaches wherein the method comprises detecting one or more risk factors in the subject ([0044]-[0045]).
Regarding claim 9, Fu teaches wherein the subject has been pre-selected for one or more risk factors ([0004]; [0010]; [0012]; [0014]; [0044]-[0045]).
Regarding claim 10, Fu teaches wherein the method comprises detecting hyperglycemia in the subject ([0012] “correlate with the condition”; [0014] “baseline”; [0032]; [0039] “hyperglycemia”; [0045]; [0106]; claims 1, 7-8).
Regarding claim 11, Fu teaches wherein the method predicts the likelihood of the subject having, or the likelihood of developing, diabetes or a diabetic condition ([0007] “predicting the future state of the entity”; [0012] “correlate with the condition”; [0014] “baseline”; [0032]; [0039] “hyperglycemia”; [0045]; [0093]; [0096] “predict glucose levels”; [0098] “predict a rise in plasma glucose”; [0106]; claims 1, 7-8, 18).
Regarding claim 12, Fu teaches wherein the method comprises treating hyperglycemia in the subject found likely to have hyperglycemia ([0039]; [0045] “treatment”; [0070] “therapy”; [0093] “therapeutic and preventative strategies”).
Regarding independent claim 18, Fu teaches a method of preventing or delaying the onset of diabetes or a diabetic condition in a subject ([0093] “therapeutic and preventative strategies”), the method comprising
a) determining the level of one or more biomarkers in a sample obtained from the subject, wherein the level or levels of the one or more biomarkers, or a value derived therefrom, as compared to a reference identifies a subject as one who is at risk of developing diabetes or a diabetic condition ([0012] “correlate with the condition”; [0014] “baseline”; [0032]; [0039] “hyperglycemia”; [0045]; [0106]; claims 1, 7-8); wherein the one or more biomarkers comprises at least one of cymene, butanol and pentanol ([0079] “1-pentanol”; [0106] “pentanol”); and
b) exposing the subject to a treatment regimen for preventing or delaying the onset of the diabetes or diabetic condition ([0045] “treatment”; [0070] “therapy”; [0093] “therapeutic and preventative strategies”).
Allowable Subject Matter with respect to 102/103
The following is a statement of reasons for the indication of allowable subject matter:
As discussed above regarding independent claims 14 and 18, Fu teaches pentanol ([0079] “1-pentanol”; [0106] “pentanol”).
Haick (US 20130236981 A1) teaches detecting cymene in breath for monitoring chronic kidney disease along with other biomarkers associated with diabetes ([0094] Table 7 “cymene”).
Dennis (US 20170074857 A1) teaches breath sample monitoring for medication adherence monitoring in which butanol is ingested and butanone levels in breath are measured as a result because diabetic patients readily excreted these ketones ([0475]); note that butanone levels are determined and not butanol.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of dependent claim 4 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the method comprises determining the levels of cymene, butanol and pentanol in the sample.
Note the “and” in recitation requires all three recited biomarkers which the prior art does not teach.
Note that the instant claim 4 is still rejected for reasons other than 102/103 as discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/ Primary Examiner, Art Unit 3792