DETAILED 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 .
Status of Claims
The claim set submitted on 16 DECEMBER 2025 is acknowledged and considered. In the claim set, Claims 1, 7-13, 19, 20, 23, 24, 29-31 are ‘Currently Amended’; Claims 26-28 are ‘Withdrawn’ ; Claims 2, 3, 14-18, 21, 22, 25 are ‘Cancelled’.
Current pending claims are Claims 1, 4-13, 19, 20, 23, 24, and 29-31 and are considered on the merits below.
Response to Amendment
Applicant’s arguments, see REMARKS, filed 16 DECEMBER 2025, with respect to the claim objection, the 112(b) rejection and the art rejection have been fully considered and are persuasive. The claim objection, the 112(b) rejection and the art rejection has been withdrawn.
Response to Arguments
Applicant's arguments filed 16 DECEMBER 2025 have been fully considered but they are not persuasive.
In response to Applicants assertion to the 101 rejection, the amendment to the claims do not further define the method to overcome the 101 rejection.
While Applicant has amended the independent claims to basically have steps (a)- (c) this does not define the methods to any more than an abstract idea without significantly more.
The methods a whole does not integrate the recited judicial exception into a practical application of the exception. And the claims does not recite any elements which are significantly more than the abstract idea.
The 101 rejection below has been amended to reflect the amendment to the claims.
While Applicant has amended Claim 1 to recite steps (a) to (c) , the level of at least three of the genes listed are measured. The claim basically focuses on ( a) measuring; (b) receiving results (no particular technique is used or mentioned) and (c) administering a treatment ( no specific treatment).
These steps are an abstract idea of mental processes in the area of mathematical calculation, grouping of “mathematical concepts”.
While step (c) mentions a treatment, this treatment is not specifically detailed so there is no particular application claimed and is therefore not significantly more than an abstract idea. The treatment is not specific and highly general.
Similarly, the same analysis is applied to Claims 11, 19 and 24. All of the mentioned independent claim are variations of Claim 1 and do not recite any elements which are significantly more than the abstract idea.
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, 11, 19, 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
The claim(s) recite(s) recite generally steps (a) to (c) , the level of at least three of the genes listed are measured. The claim basically focuses on ( a) measuring; (b) receiving results (no particular technique is used or mentioned) and (c) administering a treatment.
The “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674. Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer.
This judicial exception is not integrated into a practical application because after the measuring of above or below a specified threshold, nothing else is done. There does not appear to have any additional steps which are significantly more than the abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because expression of at least three genes, or proteins encoded by genes and generically providing a treatment is not specifically detailed so there is no particular application claimed and is therefore not significantly more than an abstract idea.
Claims 4 and 5 just define whether or not all or a selective few genes are present or not.
Claims 6-10, 12, 13, 24 recite numerically the particular threshold amounts after the levels are determined. The limitation directed to determining the levels recites a mathematical calculation. The grouping of “mathematical concepts” in the 2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea. 2019 PEG Section I, 84 Fed. Reg. at 52. Thus, limitation (a) falls into the “mathematical concept” grouping of abstract ideas. In addition, this type of simple arithmetic calculation (division) can be practically performed in the human mind, and is in fact performed in the human mind on a daily basis, for instance by school-aged children studying mathematics. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Thus, limitation also falls into the “mental process” groupings of abstract ideas. In addition, limitation describes a naturally occurring relationship, and thus may also be considered to recite a law of nature. Accordingly, limitation (a) recites a judicial exception (an abstract idea that falls within the mathematical concept and mental process groupings in the 2019 PEG, and a law of nature).
Claims 20 and 23 define what condition could be present based on Table 1 and generic common treatment is administered. The treatment listed is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s outcome into account when deciding which treatment to administer, making the limitation’s inclusion in this claim at best nominal.
Claims 29-31 just define the level of expression is present, treatment is stopped if it is below a threshold. Although this limitation indicates that treatment is stopped if there expression level is not present, it is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s outcome.
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 CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797