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
Claim 1-12 and 18-19 are pending and have been examined on the merits.
Withdrawn Rejections
The rejection of claims 1-12 and 18-19 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. USPN 12,303,494 is withdrawn in view of the claim amendment.
Maintained rejection
Claim Rejections - 35 USC § 112 (Enablement)
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 1-12 and 18-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is drawn to a method for treating or preventing cancer in a subject. While the specification provides in vitro data as supporting evidence for the compounds to treat cancer, the specification fails to disclose appropriate data for the claimed method of preventing cancer in a subject through inhibiting SATB2 and/or EN2. The absence of animal models’ data is particularly significant because in vitro assays are not reliable to predict in vivo efficacy, especially when claimed treatment and prevention of cancer. Thus, without such data, a person of ordinary skill in the art (POSITA) would not know whether the compound actually achieves the claim functions. For these reasons, a POSITA would also recognize that the absence of any in vivo data or experimental results suggest that the claimed compound may not be prophylactic or used for treatment as claimed, which then significantly weakens the enablement of the claimed invention. Therefore, the absence of such data supports the conclusion that the specification does not provide adequate disclosure to conclude that the compounds can act as prophylactic or treatment through inhibiting SATB2 and/or EN2. Therefore, the lack of enablement of the claimed subject matter at the time of filing, suggest that Applicant did not possess supporting data to claim a method of treating or preventing cancer.
112 (Written description)
Claims 1-12 and 18-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a method of treating and preventing cancer in a subject, including brain cancer, and yet the specification does not clarify the type of brain cancer. In fact, the specification provides no guidance as to whether each of the listed compounds is expected to be effective against all claimed cancer types, or whether particular compounds are specific to certain cancers or subclasses as in brain cancer. Furthermore, the specification does not provide detail how the in vitro data translate to in vivo efficacy in a patient, to assess the efficacy of the treatment or preventive method. The absence of any animal data makes it unclear whether Applicant has possession of a method that is effective for treating or preventing cancer, as claimed. Furthermore, the absence of in vivo data points to the unpredictability of the claimed treatment or preventive, which is further highlighted by the specification’s reliance on prophetic language such as found in the specification (page 20, line 22-24)
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Additionally, the specification does not describe how the compound can be used for cancer prevention, nor does it indicate whether preventive approaches differ to treatment based on cancer type or whether they are universally effective across the listed cancer. The specification’s failures to disclose any specific regarding the compound efficacy an in vivo model, further supports the conclusion that the specification lacks adequate written description of the claimed subject matter.
Allowable Subject Matter
It is noted that claim 1 is free of the prior art, as are claims 2-12 and 18-19, which are dependent on claim 1. However, the claims are not allowed because of the 112(a) and double patenting rejections. As a result, until this issue is remedied or resolved; the claims cannot be subject of allowance.
Response to Argument
Applicant argues that Figures 6-8 show that silencing SATB2 and EN2 using shRNA inhibits process important for breast cancer formation. Applicant argues that these data demonstrate that inhibition of EN2 is an effective method of preventing and treating breast cancer, as example. Applicant’s argument is not persuasive because the instant claims are directed to a method of treating or preventing cancer by administering a compound, which the Figures clearly lack. It is important to highlight that shRNA knockdown is not equivalent to administration of a therapeutic compound, and the specification does not provide evidence that any of the claimed compounds inhibits EN2 and/or SATB2 and leads to prevention or treatment of breast cancer, as an example. Furthermore, “preventing” cancer generally refers to reducing the risk of cancer prior to disease onset. The specification or Figures 6-8 do not present data demonstrating that administering any of the claimed compounds reduces cancer risk, delay onset, or prevent development of cancer in any relevant animal model. The Figures 6-8 only demonstrate altering cellular processes via shRNA, which is clearly distinct to the claim method of compound-based cancer treatment or prevention.
Applicant argues that 3D organoid cultures serve as alternatives to animal testing because they mimic organ structure and function. Applicant also argues that Figures A5-A6 and others show organoid viability data demonstrating cancer cell inhibition across multiple tumor types, supporting the claimed method of treating and preventing cancer. Applicant’s argument is not persuasive because while 3D organoid culture represents an emerging and valuable research tool, they are not equivalent to animal models for establishing method of treating or preventing cancer. As evidence by Varinelli (page 8-9) discloses that Patient-derived organoids (PDOs)
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fail to fully preserve heterogeneity due to selective expansion of highly proliferative clones under in vitro conditions, resulting in loss of clinically relevant subpopulations associated with treatment resistance. In addition, the absence of standardized culture protocol leads to variability and limits reproducibility across studies. Furthermore, organoid systems lack the complex tumor microenvironment present in living organism, thus organoids cannot model whole-body drug responses which is essential for evaluating cancer treatment and prevention. For these reasons, organoid viability data alone do not demonstrate that administering the claimed compound would treat or prevent cancer in vivo. Thus, organoids system functions as complementary experimental systems rather than replacement or equivalent systems for animal models.
Declaration/Affidavit by Rakesh K. Srivastava
Applicant submits an affidavit as supplementary evidence, as to provide additional support for the claimed methods of treating or preventing cancer. Applicant’s argument is not persuasive because the affidavit does not present new or previously unconsidered data. Rather, the affidavit repeats conclusions and interpretation based on data already disclosed in the instant application, which the Examiner has fully considered; thus, the 112 rejection is maintained.
Conclusion
No claims are presently allowed.
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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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622