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 .
DETAILED ACTION
Status of the Claims
Claims 3-4, 6-7, 9-13, 17, 20-21, 23-24, 28 and 32-36 are pending in this application.
Claims 3-4, 6-7, 9-13, 17, 20-21, 23-24, 28 and 32-36 are presently under consideration.
Sequence Compliance
Applicant is advised that the application is not in compliance with 37 CFR §§ 1.821-1.825.
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR § 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR §§ 1.821-1.825. Applicant must comply with the requirements of the sequence rules (37 CFR §§ 1.821- 1.825) in order to completely respond to this office action.
Specifically, the amino acid sequence presented in claim 11 requires a sequence identifier. In order to satisfy the sequence rules requirements, Applicant needs to provide an amendment to the instant claims, specification and drawings to include reference to the appropriate sequence identifier “SEQ ID NO:” in parenthesis next to each of the sequences having 4 or more amino acids. Please confirm that all peptides having 4 or more than 4 amino acid residues have sequence identifiers and are included in the sequence listing.
In case of any new sequences not properly identified in the instant specification, Applicant is required to provide a substitute computer readable form (CRF) copy of a “Sequence Listing” which includes all of the sequences that are present in the instant application and encompassed by these rules, a new or substitute paper copy of that “Sequence Listing”, an amendment directing the entry of that paper copy into the specification, and a statement that the content of the paper and computer readable copies are the same and, where applicable, include no new matter, as required by 37 C.F.R. § 1.821(e) or 1.821(f) or 1.821(g) or 1.825(d). The instant specification will also need to be amended so that it complies with 37 C.F.R. § 1.821(d) which requires a reference to a particular sequence identifier (SEQ ID NO:) be made in the specification and claims wherever a reference is made to that sequence. For rules interpretation Applicant may call (571) 272-2533. See M.P.E.P. 2422.04.
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Claim Objections
Claims 3, 9 and 35 are objected to because of the following informalities: With respect to claims 3 and 35, the acronyms “EAG2”, “Kvb2” and “IDH” should be spelled out the first time they are mentioned in the claims. Claim 9 should be amend to recite “The recombinant polypeptide of claim 3, wherein the polypeptide for preventing or reducing interaction between EAG2 and Kvb2 consists of . 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 3-4, 6, 10-13, 17, 20-21, 23-24 and 28, 32-36 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.
The claims are drawn to a recombinant polypeptide comprising: a) a polypeptide for preventing or reducing interaction between EAG2 and Kvß2 comprising: i) a contiguous portion of human Kvß2 (SEQ ID NO: 26) comprising at least amino acids 90 to 114 of SEQ ID NO: 26, or ii) a polypeptide that is at least 70% identical to i); and b) a cell-penetrating peptide; and a method of treating cancer comprising administering the recombinant polypeptide.
When referring to the recombinant polypeptide that is at least 70% identical to amino acids 90 to 114 of SEQ ID NO: 2, the specification does not provide any structural attributes.
Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“A definition by function alone “does not suffice” to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is”).”
Here, the specification fails to describe which amino acids of the sequence comprising amino acids 90 to 114 of SEQ ID NO: 2 correlate with the required activity (i.e. preventing or reducing interaction between EAG2 and Kvß2; and treating cancer).
The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad.
It is noted that amino acids 90 to 114 of SEQ ID NO: 2 is a stretch of 25 amino acids. Therefore, even considering only natural amino acids one would end up with 48,454,560,000 (25x24x23x22x21x20x19x20) possible polypeptides at least 70% identical to amino acids 90 to 114 of SEQ ID NO: 2; or 12,000 (25x24x20) possible polypeptides at least 90% identical to amino acids 90 to 114 of SEQ ID NO: 2.
However, the specification fails to provide a representative number of examples for the claimed polypeptide.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Therefore, since the specification fails to identify any relevant structural characteristics that can be attributed to the claimed function and activity, the claimed invention lacks written description.
Claims 24, 28 and 32-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for: 1) the prevention or reduction of the interaction between EAG2 and Kvb2 in a cell; and 2) the treatment of medulloblastoma and glioblastoma with the recombinant polypeptide comprising at least amino acids 90 to 114 of SEQ ID NO: 26, does not reasonably provide enablement for: a) the prevention or reduction of the interaction between EAG2 and Kvb2 in a cell with the recombinant polypeptide having at least 70% identity to amino acids 90 to 114 of SEQ ID NO: 26; b) the treatment of each and every cancer with the recombinant polypeptide; and c) the treatment of any cancer with the recombinant polypeptide having at least 70% identity to amino acids 90 to 114 of SEQ ID NO: 26. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The MPEP states:
“There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.”
(A) The breadth of the claims; and (B) The nature of the invention;
The claims are drawn to a method of treating cancer in a subject in need thereof comprising administering to the subject the recombinant polypeptide as defined in claim 3.
(C) The state of the prior art;
The state of the prior art does not indicate that each and every cancer can be treated. For instance, Costello et al. (Pancreat Disord Ther; Suppl 4; doi:10.4172/2165-7092.S4-002) teaches that pancreatic cancer is an untreatable cancer (abstract).
(D) The level of one of ordinary skill;
The skill of those skilled in the art is high.
(E) The level of predictability in the art;
Considering that not all cancers can be treated, the unpredictability of treatment of each and every cancer with the claimed polypeptide is very high.
(F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The specification does not provide any examples with respect to: 1) the prevention or reduction of the interaction between EAG2 and Kvb2 in a cell with the recombinant polypeptide comprising at least amino acids 90 to 114 of SEQ ID NO: 26; and 2) the treatment of any cancer, other than medulloblastoma and glioblastoma, with the recombinant polypeptide comprising at least amino acids 90 to 114 of SEQ ID NO: 26.
The MPEP (2164.02) states that " The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).” The MPEP further states that
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“Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”
In the instant application, the specification does not provide any guidance to allow for:
a) the prevention or reduction of the interaction between EAG2 and Kvb2 in a cell with the recombinant polypeptide having at least 70% identity to amino acids 90 to 114 of SEQ ID NO: 26;
b) the treatment of each and every cancer with the recombinant polypeptide; and
c) the treatment of any cancer with the recombinant polypeptide having at least 70% identity to amino acids 90 to 114 of SEQ ID NO: 26.
Working examples are necessary since the art has indicated unpredictability of treatment of such diseases is very high.
Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the invention as claimed.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
Prosecution Insights