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. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 28, 2026 has been entered. 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 Any rejections or objections not reiterated herein have been withdrawn.
Claims 1 and 5-8 are currently pending.
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 5-8 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.
Claim 1 is rejected as being indefinite because it requires “determining an increase in the expression of SEQ ID NOs: 1, 3, 5, and 6 in the tumor from the patient with NSCLC”. The term “increased” is a relative term which renders the claim indefinite. This rejection could be overcome by amending the claim to recite what the increased expression is in comparison to so that one of skill in the art would be apprised of the scope of 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 “one or more 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.
Claim 6 is rejected as being indefinite because it recites that “an increased mRNA expression of SEQ ID NO: 5 when compared to the expression in adjacent normal lung tissue is used to determine that said patient will show chemoresistance to adjuvant chemotherapy of carboplatin”. This is claim confusing because claim 1 requires administering carboplatin to a patient with an increased in the expression of SEQ ID NO: 5. It unclear why carboplatin would be administered to patients with increased expression of SEQ ID NO: 5 (in claim 1) if increased expression of SEQ ID NO: 5 is correlated with chemoresistance to this drug (in claim 6). Clarification is required.
Claim 7 is rejected as being indefinite because it recites that “wherein an increased mRNA expression of SEQ ID NO:6 when compared to expression in adjacent normal lung tissue is used to determine that said patient will show chemoresistance to adjuvant chemotherapy of one or more of (a) carboplatin and Taxol (paclitaxel), (b) carboplatin and Taxotere (docetaxel), (c) cisplatin and Taxotere (docetaxel), and (d) cisplatin and Taxol (paclitaxel)”. This is claim confusing because claim 1 encompasses administering Carboplatin and Taxol, Carboplatin and Taxotere, Cisplatin and Taxotere, or Cisplatin and Taxol to a patient with an increased in the expression of SEQ ID NO: 6. It unclear why Carboplatin and Taxol, Carboplatin and Taxotere, Cisplatin and Taxotere, or Cisplatin and Taxol would be administered to patients with increased expression of SEQ ID NO: 6 (in claim 1) if increased expression of SEQ ID NO: 6 is correlated with chemoresistance to these drugs (in claim 7). Clarification is required.
Claim 8 is rejected as being indefinite because it recites that “wherein an increased mRNA expression of SEQ ID NO:3 when compared to expression in adjacent normal lung tissue is used to determine that said patient will show chemoresistance to adjuvant chemotherapy of one or more of (a) Taxol (paclitaxel) and (b) Alimta (pemetrexed)”. This is claim confusing because claim 1 encompasses administering Carboplatin and Taxol or Cisplatin and Taxol to a patient with an increased in the expression of SEQ ID NO: 3. It unclear why Carboplatin and Taxol or Cisplatin and Taxol would be administered to patients with increased expression of SEQ ID NO: 3 (in claim 1) if increased expression of SEQ ID NO: 3 is correlated with chemoresistance to Taxol (in claim 8). Clarification is required.
Claim Rejections - 35 USC § 112(a)
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6 and 7 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
A. In the instant case the specification does not appear to provide support claim 6 which recites that “an increased mRNA expression of SEQ ID NO: 5 is used to determine that said patient will show chemoresistance to adjuvant chemotherapy of carboplatin”.
The specification (para 0011) recites that “High expression of FUT7 (SEQ ID NO:5) predicted chemosensitivity to Carboplatin”
The specification (para 0079) recites that “Another method of this invention provides for the high expression of FUT7 (SEQ ID NO:5) predicted chemosensitivity to carboplatin”.
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Thus while the specification discloses that an increased mRNA expression of SEQ ID NO: 5 is correlated with chemosensitivity to adjuvant chemotherapy of carboplatin, it does not provide support for increased mRNA expression of SEQ ID NO: 5 being correlated with chemoresistance to adjuvant chemotherapy of carboplatin.
B. In the instant case the specification does not appear to provide support claim 7 which recites that “an increased mRNA expression of SEQ ID NO:6 when compared to expression in adjacent normal lung tissue is used to determine that said patient will show chemoresistance to adjuvant chemotherapy of one or more of (a) carboplatin and Taxol (paclitaxel), (b) carboplatin and Taxotere (docetaxel), (c) cisplatin and Taxotere (docetaxel), and (d) cisplatin and Taxol (paclitaxel).”.
The specification (para 0011) recites that “High expression of ZNF71 (SEQ ID NO:6) predicted chemosensitivity to Carboplatin and Taxol, Carboplatin and Taxotere, Cisplatin and Taxotere, and Cisplatin and Taxol.”
The specification (para 0080) recites that “Another method of this invention provides for the high expression of ZNF71 (SEQ ID NO:6) predicted chemosensitivity to carboplatin and Taxol (paclitaxel), carboplatin and Taxotere (docetaxel), cisplatin and Taxotere (docetaxol), and cisplatin and Taxol (paclitaxel)”.
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Thus while the specification discloses that an increased mRNA expression of SEQ ID NO: 6 is correlated with chemosensitivity to adjuvant chemotherapy with Carboplatin and Taxol, Carboplatin and Taxotere, Cisplatin and Taxotere, and Cisplatin and Taxol, it does not provide support for increased mRNA expression of SEQ ID NO: 6 being correlated with chemoresistance to adjuvant chemotherapy of Carboplatin and Taxol, Carboplatin and Taxotere, Cisplatin and Taxotere, and Cisplatin and Taxol.
11. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Shen can be reached on 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA HANEY/Primary Examiner, Art Unit 1682
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