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 the Claims
Claims 16-24 and 30-32 were pending and are examined herein.
Claim Objections
Claims 16-17 and 20-21 are objected to because of the following informalities:
Claim 16 contains abbreviation TIF1. Claim 17 contains abbreviation CCAR1. Claim 20 contains abbreviation DM. Claim 21 contains abbreviations GATD1, TBLlXRl, KDM2A, IMMT, SOX5, CIZl, NVL2, and NACCI. Abbreviations should be completely spelled out in their first occurrence.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 16-24 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 16 recites detecting a presence of an anti-TIF1-γ antibody and an absence of a decreased cancer risk antibody in a sample obtained from a mammal, and administering an inhibitor of a DCR polypeptide to said mammal; and claim 17 recites treating a mammal having cancer, the method comprising administering an inhibitor of a CCAR1 polypeptide to a mammal identified as having a presence of an anti-TIF1-γ antibody and an absence of a DCR antibody.
The prior art is silent on detecting the presence/absence of said antibodies and administering inhibitors of the DCR polypeptides.
Claim 16 recites “a mammal having cancer”, but the specification only discloses data for humans. Thus, the broad genus of mammals is not supported by the evidence.
Claim 16 recites “an inhibitor of a DCR polypeptide”, but the specification fails to disclose examples of a broad category of DCR polypeptide inhibitors for cancer treatment. The prior art is silent on the DCR polypeptide inhibitors for cancer treatment of mammals with recited pattern of antibodies. Claim 21 recites antibodies against specific DCRs, but the specification fails to provide examples of these antibodies by structure. Disclosing antibodies by their desired function is insufficient to comply with the written description requirement.
Moreover, the specification fails to provide evidence of an anti-DCR polypeptide antibody used for a treatment of a mammal cancer and the results of such treatment.
There are two paragraphs in the specification disclosing examples of treating cancer (Examples 3 and 4). Both examples do not appear to be practical examples (pg. 51, lines 1-9 and 10-18) because their language describes desired, hypothetical scenarios of treating cancer patients. The examples do not disclose actual treatment procedures and their results. Specifically, the examples fail to disclose: patient data with levels of anti-TIF1-γ and anti-CCAR1 antibodies, diagnosed cancers, inhibitor names, doses, modes of administration, observation length, and follow up results. The statement in both examples that “The administered inhibitor(s) can reduce or eliminate the number of cancer cells present within the human” is not a disclosure of real treatment results, but a description of a desired effect.
Figures 3A-3D show graphs and tables related to an increasing number of antibody targets observed (Figures 3A-3C) with lengthening time between DM diagnosis and cancer emergence (Figure 3D) (pg. 7, lines 13-15). However, these results are not related to an anti-DCR polypeptide antibody treatment.
Other examples in the specification also fail to provide evidence to demonstrate the possession of the claimed invention:
Example 1: Immune responses to CCAR1 and other novel dermatomyositis autoantigens were associated with attenuated cancer emergence. This example identifies autoantibodies against CCAR1 present in dermatomyositis (DM) patients (pg. 29, last 2 par.). The objective of this study was to identify autoantigens preferentially targeted by patients in whom cancer did not emerge (pg. 30, lines 5-6); and
Example 2: ELISA assay to detect antibodies against CCAR1 in human sera (pg. 47, last par. – pg. 50).
Examples 1 and 2 fail to disclose evidence of actual patients subjected to claimed treatment, the treatment administered, and its effectiveness.
Finally, administration of anti-DCR polypeptide antibodies to patients does not necessarily results in interaction of the administered antibodies with their targets because the targets are intracellular proteins and Applicant fails to provide evidence that the antibodies can penetrate inside the cells or perform their inhibitory function outside the cells.
Some prior art provides evidence that CCAR1 has a beneficial function in the cells. Kim et al. (Mol Cell. 2008 Aug 22;31(4):510-519) teach that CCAR1 acts as a coactivator for p53 (pg. 510, col. 2, par. 3). The p53 protein is a well-known transcription activator preventing cancer formation. Inactivating CCAR1 as Applicant suggests could lead to more pronounced cancer effects in the patients.
Based on the above findings, one of ordinary skill in the art would conclude that the inventor was not in possession of the invention as claimed in view of the disclosure of the application as filed.
Claims 18-24 are rejected because they depend from rejected claim 16.
Therefore, claims 16-24 are rejected under 35 U.S.C. 112(a).
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 21 and 23 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 21 recites the DCR antibody comprises each of an anti-CCAR1 antibody, an anti-GATD1 antibody, an anti-TBLlXRl antibody, an anti-KDM2A antibody, an anti-IMMT antibody, an anti-SOX5 antibody, an anti-CIZl antibody, an anti-NVL2 antibody, and an anti-NACCI antibody.” It is unclear if the claim requires all recited antibodies to be present: “comprises each of … and …”. For a Markush claim this claim is indefinite because of the open “comprising” language.
Claim 23 recites said inhibitor of said CCAR1 polypeptide is an anti-CCAR1 antibody. There is insufficient antecedent basis for this limitation in the claim, because parent claim 16 does not recite a CCAR1 polypeptide.
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
Claims 30-32 are free of the prior art. The prior art does not teach a method for detecting an anti-CCAR1 antibody in a sample. Polypeptide fragments of SEQ ID NO: 1 or SEQ ID NO:2 immobilized on an ELISA plate are not known in the art.
Subject Matter Free of the Prior Art
Claims 16-24 are free of the prior art.
The method for treating a mammal having cancer, said method comprising:
detecting a presence of an anti-TIF1-γ antibody and an absence of a decreased cancer risk
antibody in a sample obtained from said mammal; and administering an inhibitor of a DCR polypeptide to said mammal is not known in the art.
The prior art neither teaches nor suggests detecting a decreased cancer risk antibody and administering an inhibitor of a DCR polypeptide. The closest prior art of Fiorentino et al. (IDS; Arthritis Rheum. 2013 Nov;65(11):2954-62) teaches detecting anti-TIF1-γ antibody, but fails to teach detecting an anti-CCAR1 or any other DCR antibody and administering an inhibitor of a DCR polypeptide.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER ALEXANDROVIC VOLKOV/Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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