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 .
2. This action is in response to the papers filed September 9, 2026. Applicant’s remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any rejections or objections not reiterated herein have been withdrawn. This action is made FINAL.
Claims 1 and 5 are currently pending and have been examined herein.
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 5-8 are rejected as being indefinite because they first require “determining an increase in the expression of SEQ ID NOs: 1, 3, 5, and 6 in the tumor from the patient with NSCLC” and then require “administering to the patient with an increase in the expression of SEQ ID NOs: 1, 3, 5, or 6 in the tumor a therapeutically effective amount of said one or more adjuvant chemotherapies”. It is unclear if the claims require that each of the recited genes have increased expression (in view of the use of “and”) OR if the claims require that only one or more of the recited genes have increased expression (in view of the use of “or”). Clarification is required.
Claims 1 and 5-8 are rejected over the recitation of the phrase “said one or more adjuvant chemotherapies” in claim 1. There is insufficient antecedent basis for this limitation in the claim because although the claim previously refers to “adjuvant chemotherapy” it does not refer to “adjuvant chemotherapies”.
Claims 1 and 5-8 require administering one or more adjuvant chemotherapies selected as follows:
to the patient with an increase in the expression of SEQ ID NO:1 administering Alimta (pemetrexed):
to the patient with an increase in the expression of SEQ ID NO: 3, administering Cisplatin and Taxol, Cisplatin and Taxotere, Carboplatin, Carboplatin and Taxol, or Carboplatin and Taxotere;
to the patient with an increase in the expression of SEQ ID NO:5, administering Carboplatin; or
to the patient with an increase in the expression of SEQ ID NO:6, administering Carboplatin and Taxol, Carboplatin and Taxotere, Cisplatin and Taxotere, or Cisplatin and Taxol.
The claims are rejected as being indefinite because it is not clear how you would treat a patient if all four SEQ ID NOs: are increased. For example would this patient be treated with a combination of Alimta, Carboplatin, and then one or more of Carboplatin and Taxol, Carboplatin and Taxotere, Cisplatin and Taxotere, or Cisplatin and Taxol? Further it’s unclear how you would treat a patient having increased expression of two or three of the SEQ ID NOs. For example if SEQ ID NOS: 1 and 3 were over expressed would this patient be treated with a combination of Alimta and one or more of Carboplatin, Carboplatin and Taxol, Carboplatin and Taxotere, Cisplatin and Taxotere, or Cisplatin and Taxol? Clarification is required.
Response To Arguments
4. In the response the Applicants traversed the rejection under 35 USC 112(b).
First the Applicants state that the therapy administered is dependent on which of the genes selected from SEQ ID NOS: 1, 3, 5, or 6 is increased when compared to cancer-free tissue.
This argument has been fully considered but is not persuasive. The issue is that the claims recite an active process step of “determining an increase in the expression of SEQ ID NOs: 1, 3, 5, and 6 in the tumor from the patient”. This recitation means that each of the SEQ ID NOs: are increased in the tumor from the patient. The claims then recite an active process step of “administering to the patient with an increase in the expression of SEQ ID NOs: 1, 3, 5, or 6 in the tumor a therapeutically effective amount of said adjuvant chemotherapies”. This recitation means that one or more of the SEQ ID NOs: are increased in the tumor from the patient. This limitation directly contradicts the proceeding limitation. The rejection is maintained.
Next the Applicants argue that claim 1 has been amended to delete “one or more” as regards the adjuvant chemotherapy.
The amendment has been fully considered but does not overcome the antecedent basis issue because although the claims previously referred to “adjuvant chemotherapy” (singular), they do not previously refer to “adjuvant chemotherapies” (plural). The rejection is maintained.
Finally the Applicants argue that the specification teaches which therapies work best depending on which SEQ ID NO is present. They state that as shown in the specification, an increase in the expression of SEQ ID NO:1 (ABCC4) contraindicates the administration of Cisplatin and Taxol, Cisplatin and Taxotere, Carboplatin, Carboplatin and Taxol, or Carboplatin and Taxotere, while the increase in SEQ ID NO:5 (FUT) contraindicates all treatments except Carboplatin. The claim has been amended to provide that the respective treatment is, only. Thus, the claim is not indefinite because, as shown in FIG. 4A, the expression leads to different treatments.
This argument and the claim amendments have been fully considered but do not overcome the rejection. As discussed above the claims require that each of the SEQ ID NOs: are increased in the tumor from the patient. There is only one patient in the method. It is unclear how this patient would treated with adjuvant chemotherapy. Even if the claims were amended such that one or more of the SEQ ID NOs: are increased in the tumor from the patient, it is unclear how these patients would be treated with adjuvant chemotherapy. For example if there was a single patient with increased expression of SEQ ID NOs: 1 and 5 would that patient be given Alimta or Carboplatin? If there was a single patient with increased expression of SEQ ID NOs: 3, 5, and 6, it is noted that there is no single treatment that is predicted to work for this combination. It is not clear if they would be given Carboplatin (based on increased expression of SEQ ID NOs: 3 and 5) or if they would be given Cisplatin and Taxol (based on increased expression of SEQ ID NOs: 3 and 6). The rejection is maintained.
5. 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 extension fee 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 AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm EST.
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/AMANDA HANEY/Primary Examiner, Art Unit 1682
