DETAILED ACTION
In application filed on 11/26/2021, Claims 1-4, 6-10, 12-15, 17-21, 23 and 31 are pending. Claims 1-4, 6-10, 12-15, 17-21 and 23 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/31/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-4, 6-10, 12-15, 17-21 and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. All claims are directed to statutory categories, i.e., a method (Claims 1-4, 6-10, 12-15, 17-21 and 23) (Step 1: YES).
Analysis:
Claim 1: Ineligible.
The claim recites a series of steps or acts, including treating a subject suffering from cancer. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1: YES).
Claim 1 recites “comparing the concentration of the signature compound with a reference for the concentration of the signature compound in an individual who does not suffer from the cancer, wherein an increase or a decrease in the concentration of the signature compound compared to the reference, …”. Therefore, the claim is directed towards an abstract idea, and more specifically to the abstract idea group of a math or mental process since claim 1 relates to using a math or mental process to “ compare the concentration of the signature compound with a reference for the concentration of the signature compound in an individual who does not suffer from the cancer, wherein an increase or a decrease in the concentration of the signature compound compared to the reference, indicates that the subject is suffering from the cancer”. (Step 2A, Prong 1: YES).
This judicial exception is not integrated into a practical application. In particular, the claim recites ‘additional elements’ which are the steps performed before and after the recited abstract ideas. However, the steps before the abstract ideas are performed in order to gather data necessary to perform the determination step. Thus, these steps do not add a meaningful limitation since these steps are insignificant pre-solution activity.
In addition, the steps of detecting, in a bodily sample from a test subject, the concentration of a signature compound are recited at a high level of generality that that they amount to mere data gathering (insignificant extra-solution activity). See MPEP 2106.05(g).
While “administering a therapeutic agent capable of treating the cancer…” takes place, this step is recited at a high degree of generality and is not particular and amounts to mere instructions to only “applying” the abstract idea. See MPEP 2105.05(f).
Accordingly, these steps are ‘additional elements’ which do not integrate the abstract ideas into a practical application.
Also, Dependent claims 2-4, 6-10, 12-15, 17-21 and 23 fail to provide additional elements that would integrate claim 1 into a practical application.
Therefore these ‘additional elements’ of claim 1 do not integrate the abstract ideas (the comparing step) into a practical application because they do not impose meaningful limits on practicing the abstract ideas (Step 2A, Prong Two: NO).
Furthermore, the courts have found that limitations adding insignificant extrasolution activity to the judicial exception, such as mere data gathering in conjunction with a law of nature or abstract idea, are limitations found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception (see the 2014 Interim Guidance on Patent Subject Matter Eligibility of the Federal Register dated December 16, 2014; and MPEP 2106.05(I)(A)). Note that mere data gathering is not significantly more than the abstract idea. See MPEP 2106.05(g).
In addition, the steps of detecting signature compounds (analytes) in the bodily samples of test subjects/patients and administering therapeutics agents/drugs to the subjects/patients during cancer treatment is well-understood, routine, and conventional (WURC) in clinical diagnostics, as evidenced by any of Pan (US20040077093A1); Payrat (US20030148256A1), Hanna et al. (GB2566681B) and Chandran (US20120289471A1).
Also, dependent claims 2-4, 6-10, 12-15, 17-21 and 23 fail to provide additional limitations that would amount to significantly more than the judicial exception.
As a result, the claims do not amount to significantly more. (Step 2B: NO).
Therefore, Claim 1 is ineligible.
Moreover, Claims 2-4, 6-10, 12-15, 17-21 and 23 are rejected by virtue of dependency on Claim 1.
Allowable Subject Matter
Claims 1-4, 6-10, 12-15, 17-21 and 23 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action.
Regarding Claim 1, Payrat et al. teaches (US20030148256A1) teaches a method for treating a subject suffering from cancer, the method comprising:
providing a composition to a test subject wherein the composition comprises at least one sugar present at a concentration of more than 20,000 mg/100ml, at least one amino acid or a precursor thereof present at a concentration of at least 500 mg/100ml, and/or at least one polyol present at a concentration of more than 25,000 mg/100 ml (See Para 0007…. a storage solution which includes both glucose (in an amount of 990 mg/ml) and mannitol (in an amount of 500 mg/ml). The solution provides an improved viability of the packed red cells stored in contact therewith).
Examiner views the claimed limitation “and/or at least one polyol present at a concentration of more than 25,000 mg/100 ml” as optional and therefore not required by the Claim.
In addition, Pan (US20040077093A1) teaches:
(ii) detecting, in a bodily sample (referred to as fluid sample; Suitable fluid samples include a breath sample… [Abstract, Para 0040]) from the test subject (See Abstract… a fluid sample from the subject after the administration of the urea and then determining the presence or amount of ammonia gas in the fluid sample), the concentration of a signature compound (referred to as detectable concentration of ammonia [Para 0037]).
Further, Hanna et al. (GB2566681B) teaches:
(iii) comparing the concentration of the signature compound with a reference for the concentration of the signature compound in an individual who does not suffer from the cancer, wherein an increase or a decrease in the concentration of the signature compound compared to the reference, indicates that the subject is suffering from the cancer (See Page 3, line 1-7…the method comprising analysing the concentration of a signature compound which is formaldehyde in a bodily sample from a test subject and comparing this concentration with a reference for the concentration of the signature compound in an individual who does not suffer from pancreatic cancer, wherein an increase in the concentration of the signature compound in the bodily sample from the test subject,…); and
(iv) administering a therapeutic agent capable of treating the cancer to the test subject (See Page 5, lines 7-8…a sample from a test subject) whose concentration of the signature compound (See Page 7, lines 8-9…concentration of the signature compound selected from a C1-C3 aldehyde, C1-C3 alcohol, and C2-C10 alkane) in the bodily sample indicates that the subject is suffering from the cancer (See Page 7, lines 17-19…administering, to the test subject, a therapeutic agent or putting the test subject on a specialised diet, wherein the therapeutic agent or the specialised diet prevents, reduces or delays progression of pancreatic cancer).
Lastly, Chandran teaches (US20120289471A1) teaches a method for treating a subject suffering from cancer (See Para 0193… The amino acid derivatives of propofol of the present invention possess anti-inflammatory, anti-oxidant, anti-cancer, anti-convulsive, anti-emetic and anti-pruritic properties.), the method comprising:
providing a composition to a test subject wherein the composition comprises at least one amino acid or a precursor thereof present at a concentration of at least 500 mg/100ml (See Para 0010… The present invention is directed to pharmaceutically active drugs, having an amino acid covalently bonded thereto to form said amino acid derivative, which is administered in this form to the subject, such as a mammal; See Para 0190… Especially the glycine, proline and lysine esters of propofol are soluble at the range of more than 100 mg/ml, and in case of lysine it is greater than 250 mg/mL).
Chandran further teaches the concentration of the amino acids derivative preferably ranges from about 10 mg/mL to about 250 mg/mL (See Para 0090).
None of Pan, Hanna, Payrat and Chandran teaches or suggests that the concentration of a signature compound resulting from the metabolism of at least one sugar and/or at least one amino acid or a precursor thereof and/or at least one polyol present in a composition is previously administered to the subject, wherein the sugar is present in the composition at a concentration of more than 20,000mg/100ml, the amino acid or a precursor thereof is present in the composition at a concentration of at least 500 mg/ml and the polyol is present in the composition at a concentration of more than 25,000mg/100ml (as claimed in Claim 1).
It would constitute impermissible hindsight to detect in a bodily sample from a test subject, the concentration of a signature compound resulting from the metabolism of at least one sugar and/or at least one amino acid or a precursor thereof and/or at least one polyol present in a composition is previously administered to the subject, wherein the sugar is present in the composition at a concentration of more than 20,000mg/100ml, the amino acid or a precursor thereof is present in the composition at a concentration of at least 500 mg/ml and the polyol is present in the composition at a concentration of more than 25,000mg/100ml without a teaching or suggestion to motivate one of ordinary skill in the art to construct the claimed invention.
Response to Arguments
Applicant’s arguments, see Page 4, filed on 11/05/2025, with respect to the 35 U.S.C. §101 rejections of Claims 1-4, 6-10, 12-15, 17-21 and 23 have been fully considered and are not persuasive.
Applicant respectfully disagrees with the subject matter eligibility rejections. Nevertheless, for the sole purpose of expediting the prosecution, Applicant has amended claim 1 to further recite:
providing a composition to a test subject wherein the composition comprises at least one sugar present at a concentration of more than 20,000 mg/100ml, at least one amino acid or a precursor thereof present at a concentration of at least 500 mg/100ml, and/or at least one polyol present at a concentration of more than 25,000 mg/100 mL. …
In this regard, Applicant further notes that the Office Action also indicates that none of cited documents teaches or suggests that "the concentration of a signature compound resulting from the metabolism of at least one sugar and/or at least one amino acid or a precursor thereof and/or at least one polyol present in a composition is previously administered to the subject, wherein the sugar is present in the composition at a concentration of more than 20,000mg/100ml, the amino acid or a precursor thereof is present in the composition at a concentration of at least 500 mg/ml and the polyol is present in the composition at a concentration of more than 25,000mg/100ml (as claimed in claim 1)".
Therefore, the step of providing to a test subject a composition comprising the at least one sugar and/or at least one amino acid or a precursor thereof and/or at least one polyol present at the optimized concentrations as claimed is not routine nor conventional in clinical diagnostics.
Accordingly, Applicant respectfully submits that even assuming arguendo that the claim recites an abstract idea (which the Applicant does not concede), the newly recited step imposes meaningful limits on the claim and confines the abstract idea to a particularly, practical application in clinical diagnostics.
In light of the foregoing, Applicant respectfully submits that the claims as a whole amount significantly more than an abstract idea. Withdrawal of the subject matter eligibility rejections is respectfully requested.
Applicant’s arguments with respect to Claims 1-4, 6-10, 12-15, 17-21 and 23 have been considered and Examiner respectfully disagrees.
Regarding Applicant’s allegation that the step of providing to a test subject a composition comprising the at least one sugar and/or at least one amino acid or a precursor thereof and/or at least one polyol present at the optimized concentrations as claimed is not routine nor conventional in clinical diagnostics, Examiner submits that this step is recited is well-understood, routine, and conventional (WURC) in clinical diagnostics, as evidenced by any of Pan (US20040077093A1); Payrat (US20030148256A1), Hanna et al. (GB2566681B) and Chandran (US20120289471A1).
Also, Examiner clarifies that this step is specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present- see MPEP 2106.05(d).
In addition, Examiner submits that Applicant’s contention fails to demonstrate that the claimed limitation “comparing the concentration of the signature compound with a reference for the concentration of the signature compound in an individual who does not suffer from the cancer, wherein an increase or a decrease in the concentration of the signature compound compared to the reference, …” do not describe a mental or mathematical concept.
Specifically, independent Claim 1 recites the step of “comparing the concentration of the signature compound…” limitation and it appears that this step constitute a mathematical relationship that involves statistical analysis (Table 5, Specification).
Furthermore, regarding the recitation of the step of “administering a therapeutic agent capable of treating the cancer…” which takes place, this step is recited at a high degree of generality and is not particular and amounts to mere instructions to only “applying” the abstract idea. See MPEP 2105.05(f).
Accordingly, these steps are ‘additional elements’ which do not integrate the abstract ideas into a practical application.
Examiner suggests to applicant to further clarify this step with specificity.
In conclusion, Examiner submits that Claim 1 recite an abstract idea in the form of a mathematical concept or mental step under Step A Prong 1. Thus, the rejection under 35 U.S.C. §101 is maintained and the further analysis in Step 2A Prong 2 does provide that this judicial exception is not integrated into a practical application in the field of clinical diagnostics. In particular, the claim recites ‘additional elements’ which are the steps performed before and after the recited abstract ideas. However, the steps before the abstract ideas are performed in order to gather data necessary to perform the determination step. Thus, these steps do not add a meaningful limitation since these steps are insignificant pre-solution activity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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/OYELEYE ALEXANDER ALABI/Examiner, Art Unit 1797