DETAILED ACTION
Applicant’s claim amendments in the response filed 6/242026 are acknowledged and entered into the record.
Accordingly, Claims 58 and 68 were previously withdrawn. Claims 75-76, 78-85, 87-89 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections Maintained - 35 USC § 101
(based on amendment)
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 75-76, 78-85, 87-88 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract) without significantly more. The claim(s) recite(s) a method for detecting for expression of an antigen comprising an integrin alpha 10 subunit polypeptide and/or polynucleotide transcript which encodes an integrin alpha 10 subunit polypeptide wherein the presence of said antigen or polynucleotide is indicative of a malignant neoplasm in the central nervous system. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it does not recite something significantly different than a judicial exception. The claims describe the relationship between the expression of integrin alpha 10 subunit in a subject’s sample and said subject having a malignant neoplasm of the central nervous system. Once the integrin expression is detected there are no additional elements or combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The steps of analyzing the presence of an integrin biomarker in a biological sample is established by well understood, routine conventional methods, and in addition they are pre-solution activity, i.e. data gathering necessary to perform the correlation. The following claims and steps inform one of ordinary skilled in the art the comparison and the presence/amount of integrin alpha 10 subunit in a subject’s sample and said subject having a malignant neoplasm of the central nervous system. The claims do not recite additional elements that amount to significantly more than the judicial exception. Accordingly, these claims are not be eligible under step 2A or step 2B.
The claims are drawn to a non-statutory method having a "natural principle" as a limiting element or step without reciting additional elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself. In the instant case, the "natural principle" is: detecting integrin alpha 10 subunit and correlating it to the natural principle of a malignant neoplasm. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because assaying for candidate cancer biomarkers does not add significantly more and is not an inventive concept. Because methods for making such determinations were well known in the art, these steps simply tell researchers to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activities are normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such law. Detection of candidate cancer biomarkers has been observed by applicant but not engineered by applicant. The claims do not add significantly more to the natural phenomenon because the claims do not require a novel reagent, apparatus of incorporate a novel treatment based on the correlation.
A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Recited elements such as “detecting” and "compared", based on the natural principle impose no meaningful limit on the performance of the claimed invention. As set forth the claims do not impose meaningful limits on the performance of the claimed invention. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas). Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the recited natural principle. The claims do not "practically apply" the natural principle; rather, the claims "simply inform" the natural principle to one performing routine active method steps and do not amount to significantly more than the natural principle itself. Thus the technology used by the instant claims is well-known in the art and does not contribute significantly more to the judicial exception.
Response to Arguments
Applicant's arguments filed 6/24/2026 have been fully considered but they are not persuasive.
Applicant states because previous claim 86 was indicated as allowable, claim 75 has been amended to recite the subject matter of allowable claim 86 and therefore the rejection of record is now moot. This is not a correct statement. Yes, claim 86 was previously indicated as allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims. Claim 86 previously depended on Claim 77, which has been canceled and which limitations were NOT amended into independent claim 75, which is rejected under 101. Therefore, the claims as written without the limitations of administering an integrin alpha 10 subunit antibody as stated in previously pending Claim 77 are rejected as a non-statutory method having a "natural principle" under 35 U.S.C. 101.
Conclusion
Claims 75-76, 78-85, 87-88 are rejected.
Claim 89 is allowable.
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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/Meera Natarajan/Primary Examiner, Art Unit 1643
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