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 .
1. The Amendment filed June 25, 2026 in response to the Office Action of March 25, 2026, is acknowledged and has been entered. Claims 21-40 are pending and being examined. Claims 21, 39, and 40 are amended.
Claim Interpretation
2. Claim 39 is amended to recite:
A method for designing a personalised therapy and treating for a subject suffering from cancer comprising detecting the expression of IL13Rα2 in a cancer cell isolated from a biological sample of the subject, wherein if the expression of IL13Rα2 is detected, then a therapy comprising the monoclonal antibody according to claim 21 is administered to the subject.
Claim 39 as amended is interpreted to comprise TWO possible outcomes:
(1) detecting and positively identifying expression of IL13Rα2 in a cancer cell from a biological sample of the subject and administering to the subject the monoclonal antibody according to claim 21; or
(2) NOT detecting expression of IL13Rα2 in a cancer cell from a biological sample of the subject and no further action is taken.
Maintained Rejections
(with amendments addressed)
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.
3. Claims 39 and 40 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature/ a natural phenomenon) without significantly more. Claims 39 and 40 are rejected based on outcome (2) defined in the claim interpretation above, where a subject is tested for expression of IL13Rα2 in a cancer cell isolated from a biological sample of a subject, no IL13Rα2 is detected, and no further action is taken. The claim(s) recite detecting the expression of IL13Rα2 in a cancer cell isolated from a biological sample of a subject. Thus, the claims are directed to the judicial exception of naturally occurring IL13Rα2 expression in patient cancer cells. This judicial exception is not integrated into a practical application because the claims recite only the detection or observation of a naturally occurring phenomenon/law of nature, which is data gathering to observe the naturally occurring phenomenon/law of nature without applying the data to a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite use of routine laboratory procedures to detect and observe naturally occurring levels of IL13Rα2, are considered known, routine steps and are typically taken by those in the field to perform testing of a sample and are not elements that are sufficient to amount to significantly more than the judicial exception (see MPEP 2106.05(d)). For example, Zeng et al (Am. J. Transl. Res. 2020, 12:4702-4714); Kawakami et al (Clinical Cancer Research, 2003, 9:6381-6388); Kioi et al (Cancer, 2006, 107:1407-1418); Bartolome et al (Oncoscience, 2015, 12:787-788); and WO 2021207770, Balyasnikova, claiming priority to April 2020, all teach and demonstrate routine methods for detecting IL13Rα2 expression in patient cancer cells. Routine data gathering in order to observe a natural phenomenon/ natural principle does not add a meaningful limitation to the method as it would be routinely used by those of ordinary skill in the art in order to observe the natural phenomenon/ natural principle, and it fails to narrow the scope of the claims such that others are not foreclosed from using the law of nature/natural phenomenon. Methods of detecting natural phenomenon preempt all practical uses of it as others must use/detect the natural phenomenon to apply it to any other correlations, diagnosis, prognosis, therapeutic response, monitoring, etc.
To obviate the rejection, there must be at least one additional element or physical step that applies, relies on, or uses the natural principle so that the claim amounts to significantly more than the judicial exception itself. The claimed method currently fails to provide a practical application of the judicial exception and fails to add any elements that amount to significantly more than the judicial exception.
Examiner Suggestion: Amend claim 39 to recite: A method for designing a personalized therapy and treating for a subject suffering from cancer, the method comprising detecting and identifying the expression of IL13Rα2 in a cancer cell isolated from a biological sample of the subject, and administering a therapy comprising the monoclonal antibody according to claim 21 to the subject.
Response to Arguments
4. Applicants argue claim 39 is amended to recite that the monoclonal antibody is now administered to the subject, therefore the judicial exception is practically applied.
5. The arguments have been considered but are not persuasive. As stated in the claim interpretation and rejection, amended claim 39 comprises two possible outcomes, one of which does not require positive identification of IL13Rα2 expression in the cancer cells and administration of antibody. Claim 39 as amended only requires administering the antibody therapy if the expression of IL13Rα2 is detected. The rejection is maintained for the method that results in no positive IL13Rα2 detection and no antibody administration because it fails to practically apply the judicial exception and amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
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.
6. Claim(s) 39 and 40 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kioi et al (Cancer, 2006, 107:1407-1418).
Claims 39 and 40 are rejected based on outcome (2) defined in the claim interpretation above, where a subject is tested for expression of IL13Rα2 in a cancer cell isolated from a biological sample of a subject, no IL13Rα2 is detected, and no antibody treatment is administered.
Kioi teaches an in vitro method for detecting the expression of IL13Rα2 in a cancer cell isolated from a biological sample of a subject, including metastatic cancer, wherein several cancer patients were found to be negative for IL13Rα2 staining (Materials and Methods on p. 1408-1409; Figure 1; Tables 1 and 2).
Response to Arguments
7 Applicants argue claim 39 is amended to recite that the monoclonal antibody is now administered to the subject and Koi does not teach this step.
8. The arguments have been considered but are not persuasive. As stated in the claim interpretation and rejection, amended claim 39 comprises two possible outcomes, one of which does not require positive identification of IL13Rα2 expression in the cancer cells and administration of antibody. Claim 39 as amended only requires administering the antibody therapy if the expression of IL13Rα2 is detected. The rejection is maintained for the method that results in no positive IL13Rα2 detection and no antibody administration.
9. All other objections and rejections recited in the Office Action mailed March 25, 2026, are hereby withdrawn in view of amendments.
10. Conclusion: Claims 39 and 40 are rejected. Claims 21-38 are allowed.
Conclusion
11. 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.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA B GODDARD whose telephone number is (571)272-8788. The examiner can normally be reached Mon-Fri, 7am-3:30pm.
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/Laura B Goddard/Primary Examiner, Art Unit 1642
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