DETAILED ACTION
In application filed on 11/26/2021, Claims 1-3, 6-10, 12-15, 17-21, 23 and 31 are pending. Claims 1-3, 6-10, 12-15, 17-21, 23 and 31 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 Interpretation
Regarding Claim 1, Examiner views the claimed limitation “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” as any of:
“at least one sugar present at a concentration of more than 20,000 mg/100ml, at least one amino acid present at a concentration of at least 500 mg/100ml wherein the limitation “and/or at least one polyol present at a concentration of more than 25,000 mg/100 ml” is optional and thus not required by the claim OR
“at least one sugar present at a concentration of more than 20,000 mg/100ml, at least one amino acid precursor present at a concentration of at least 500 mg/100ml wherein the limitation “and/or at least one polyol present at a concentration of more than 25,000 mg/100 ml” is optional and thus not required by the claim.
Further, Examiner views the limitation “(ii) detecting, in a bodily sample from the test subject, the concentration of a signature compound resulting from the metabolism of the at least one sugar and/or the at least one amino acid or a precursor thereof and/or the at least one polyol present in the composition” as any of:
detecting, in a bodily sample from the test subject, the concentration of a signature compound resulting from the metabolism of the at least one sugar present in the composition” OR
detecting, in a bodily sample from the test subject, the concentration of a signature compound resulting from the metabolism of the at least one amino acid present in the composition” OR
detecting, in a bodily sample from the test subject, the concentration of a signature compound resulting from the metabolism of the at least one amino acid precursor present in the composition” OR
detecting, in a bodily sample from the test subject, the concentration of a signature compound resulting from the metabolism of the at least one polyol present in the composition”
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 1-3, 6-10, 12-15, 17-21, 23 and 31 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 1-3, 6-10, 12-15, 17-21, 23 and 31) (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 “…if there is an increase in the concentration of the signature compound detected in the bodily sample from the test subject relative to a reference for the concentration of the signature compound”. 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 “determine if there is an increase in the concentration of the signature compound detected in the bodily sample from the test subject relative to a reference for the concentration of the signature compound”. (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.
It appears that the steps of “providing a composition to a test subject…” and “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).
In addition, while the step of “administering a therapeutic agent to the test subject” 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).
Further, the administering step 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 medical professional decides to administer to the patient. As such, there are no meaningful constraints on the administering step such that the particular treatment or prophylaxis consideration would apply because it is not limited to any particular manner or type of treatment. The limitation is at most an instruction to “apply” the judicial exception.
Therefore these ‘additional elements’ of claim 1 do not integrate the abstract ideas (the evaluation step) into a practical application because they do not impose meaningful limits on practicing the abstract ideas (Step 2A, Prong Two: NO).
Step 2B:
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 “providing a composition to a test subject…” and “detecting, in a bodily sample from a test subject, the concentration of a signature compound…” are well-understood, routine, and conventional (WURC) in clinical diagnostics, as evidenced by any of Feinberg et al. "Cancerous glucose metabolism in lung cancer—evidence from exhaled breath analysis." Journal of Breath Research 10.2 (2016): 026012.”; Pan (US20040077093A1); Payrat (US20030148256A1), Hanna et al. (GB2566681B); Hanna et al. (GB2566681A) 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 2-3, 6-10, 12-15, 17-21, 23 and 31 are rejected by virtue of dependency on Claim 1.
Also, each of Claims 2-3, 6-10, 12-15, 17-21, 23 and 31 do not solve the 101 issues of Claim 1.
Claims 2-3: Ineligible.
Step 2A, Prong One and Prong Two: Claims 2-3 further define the data gathering steps, which appear to be generic and WURC.
Step 2B: The claims do not recite any elements which are significantly more.
Therefore, Claims 2-3 are ineligible.
Claims 6-10, 12-15, 17-21, 23 and 31: Ineligible.
Step 2A, Prong One and Prong Two: Claims 6-10, 12-15, 17-21, 23 and 31 further provide the properties of the composition, which appear to be generic and WURC.
Step 2B: The claims do not recite any elements which are significantly more.
Therefore, Claims 6-10, 12-15, 17-21, 23 and 31 are ineligible.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Feinberg ("Cancerous glucose metabolism in lung cancer—evidence from exhaled breath analysis." Journal of Breath Research 10.2 (2016): 026012.) teaches a method for treating a subject suffering from cancer (See Page 2; Section 2.2… Naïve LC patients were defined as patients not receiving any form of anti-cancer therapy prior to their involvement in this research), 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 (See Page 2; Section 2.3.1… The participants were requested to fast for a period of 6 h before drinking a glucose solution (273 ml) that contained 75 g of glucose. Examiner submits that the glucose concentration converts 27,473.53 mg/100ml)
detecting, in a bodily sample (‘breath’) from the test subject (See Page 2; Section 2.3.1…After drinking the solution, the participants were required to wait a lay period of 90 min before the retest of their exhaled breath), the concentration of a signature compound (See Table 5; Post OGTT…Ethylbenzene, benzaldehyde…1,2-dichlorobenzene, L-glutamine, lysine) resulting from the metabolism of the at least one sugar present in the composition (See Page 6…In the post-OGTT state (post-LC versus postcontrol); See Discussion…In this study, we were able to show that LC and control patients metabolize glucose differently; See Title…glucose metabolism).
Examiner views the claimed limitation “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” as
“at least one sugar present at a concentration of more than 20,000 mg/100ml, at least one amino acid present at a concentration of at least 500 mg/100ml, and wherein the limitation “and/or at least one polyol present at a concentration of more than 25,000 mg/100 ml” is optional and thus not required by the claim.
Further, Hanna et al. (GB2566681B) teaches a method for treating a subject suffering from cancer (See Page 3; lines 11-12…there is provided a method for determining the efficacy of treating a subject suffering from pancreatic cancer with a therapeutic agent or a specialised diet), the method comprising:
(ii) detecting, in a bodily sample from the test subject, the concentration of a signature compound resulting from the metabolism of the at least one sugar present in the composition (See Page 3; lines 11-13…analysing the concentration of a signature compound which is formaldehyde in a bodily sample from a test subject).
Examiner views the claimed limitation “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” as
“at least one sugar present at a concentration of more than 20,000 mg/100ml, at least one amino acid present at a concentration of at least 500 mg/100ml, and wherein the limitation “and/or at least one polyol present at a concentration of more than 25,000 mg/100 ml” is optional and thus not required by the claim;
administering a therapeutic agent to the test subject (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) if there is an increase in the concentration of the signature compound detected in the bodily sample from the test subject relative to a reference for the concentration of the signature compound (See Page 27, lines 9-11… wherein an increase in the concentration of the signature compound in the bodily sample from the test subject, compared to the reference, suggests that the subject is suffering from pancreatic cancer, or has a predisposition thereto, or provides a negative prognosis of the subject's condition; See Page 7, lines 8-9… an increase in the concentration of the
signature compound selected from a C1-C3 aldehyde, C1-C3 alcohol, and CrC10 alkane wherein a first carbon atom is substituted with the =0 group and a second carbon atom is substituted with an -OH group, or an analogue or derivative thereof, in the bodily sample from the test subject…).
Further, Payrat et al. teaches (US20030148256A1) teaches a method, 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.
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 Feinberg, Hanna, Payrat and Chandran teaches nor suggests a method for treating a subject suffering from cancer, the method comprising:
(i) 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 (as claimed in Claim 1).
Response to Arguments
Applicant’s arguments, see Page 6, filed 05/08/2026, with respect to the 35 U.S.C. §101 rejections of Claims 1-3, 6-10, 12-15, 17-21, 23 and 31have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made for amendment Claim 1.
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. …
Claim 1 as amended does not recite a comparison step and thus does not recite an abstract idea. Dependent claims of claim 1 also do not recite a comparison step and thus do not recite an abstract idea. Thus, amended claim 1 and its dependent claims are not directed to an abstract idea. Even assuming the claims are directed to an abstract idea, which Applicant does not concede, the claims recite additional elements that amount to significantly more than an abstract idea…
Not abstract idea under Step 2A-Prong 1
The Office Action states that under the Step 2A, Prong One evaluation, claim 1 recites a comparing step and is directed towards an abstract idea, and more specifically to the abstract idea group of a math or mental process. Office Action, p. 3…
Improvement and in conjunction with a particular machine to integrate an abstract idea into a practical application under Step 2A-Prong 2
Under Step 2A Prong 2, the Office Action states that the steps other than the comparing steps are insignificant pre-solution activity and/or are recited at a high degree of generality. Office Action, pp. 3-4. The Office Action concludes "these steps are 'additional elements' which do not integrate the abstract ideas into a practical application." Id….
Improvement amounting to significantly more than a judicial exception under Step 2B
An "inventive concept" can be furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. MPEP § 2106.05(I); and Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012))…
Accordingly, Applicant respectfully submits the claim 1 as amended and its dependent claims are not directed to an abstract idea. Even if the claims are directed to an abstract idea, which Applicant does not concede, the claims as a whole amount significantly more than the abstract idea. Withdrawal of the subject matter eligibility rejections is respectfully requested.
Applicant’s arguments with respect to amended claim 1 has been considered and Examiner respectfully disagrees.
Examiner submits that the limitations of amended Claim 1 is taught as disclosed in the 101 rejection of amended Claim 1 in the body of the office action, where amended Claim 1 presents a new abstract idea “…if there is an increase in the concentration of the signature compound detected in the bodily sample from the test subject relative to a reference for the concentration of the signature compound”.
This limitation 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 “determine if there is an increase in the concentration of the signature compound detected in the bodily sample from the test subject relative to a reference for the concentration of the signature compound”.
Further, the limitation recites an “if” clause which is a contingent limitation.
MPEP 2111.04 II states that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
As the limitation “…if there is an increase in the concentration of the signature compound detected in the bodily sample from the test subject relative to a reference for the concentration of the signature compound” is recited, it appears that if there is a decrease in the concentration of the signature compound detected in the bodily sample from the test subject relative to a reference for the concentration of the signature compound, then there is no administration of the therapeutic agent.
Therefore, the administering step is not integrated into a practical application as the step does have to occur.
Further, the administering step 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 medical professional decides to administer to the patient. As such, there are no meaningful constraints on the administering step such that the particular treatment or prophylaxis consideration would apply because it is not limited to any particular manner or type of treatment. The limitation is at most an instruction to “apply” the judicial exception.
Therefore these ‘additional elements’ of claim 1 do not integrate the abstract ideas (the evaluation step) into a practical application because they do not impose meaningful limits on practicing the abstract ideas.
Lastly, the steps of “providing a composition to a test subject…” and “detecting, in a bodily sample from a test subject, the concentration of a signature compound…” are well-understood, routine, and conventional (WURC) in clinical diagnostics, as evidenced by any of Feinberg et al. "Cancerous glucose metabolism in lung cancer—evidence from exhaled breath analysis." Journal of Breath Research 10.2 (2016): 026012.”; Pan (US20040077093A1); Payrat (US20030148256A1), Hanna et al. (GB2566681B); Hanna et al. (GB2566681A) and Chandran (US20120289471A1). As a result, the claim does not amount to significantly more.
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; thus the claims do not amount to significantly more.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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
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