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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/1/2026 has been entered.
Claim Status
Claims 1-8 and 10-16 are pending. Claims 15-16 have been added. Claim 1 has been amended. In the response to the restriction requirement, Applicants elected Group I and SEQ ID NO: 13. Claims 1-8, 10-13 and 15-16 are presently under consideration as being drawn to the elected invention. Claim 14 is withdrawn from consideration as being drawn to a non-elected invention.
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 1-8, 10-13 and 15-16 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 protein comprising an ankyrin repeat domain, wherein said ankyrin repeat domain comprises an N- terminal capping module, wherein said N-terminal capping module has an amino acid residue selected from the group consisting of: I, A, V and M, at the position corresponding to position 15 of SEQ ID NO: 3, and wherein said ankyrin repeat domain exhibits an increased melting temperature (Tm) as compared to an ankyrin repeat domain with a D at position 15.
The only requirement of the claim is that the N-terminal capping module comprises an amino acid residue selected from the group consisting of: I, A, V and M, at the position corresponding to position 15 of SEQ ID NO: 3.
It is noted that, as written, the claim does NOT require the N-terminal capping module to comprise SEQ ID NO: 3 wherein the amino acid at position 15 is substituted with I, A, V or M, but rather it requires the N-terminal capping module to comprise just an amino acid (i.e. I, A, V or M).
There is no support in the specification for the claimed protein comprising only one amino acid.
To advance prosecution, the claim has been interpreted as being drawn to “A protein comprising an ankyrin repeat domain, wherein said ankyrin repeat domain comprises an N- terminal capping module, wherein said N-terminal capping module comprises SEQ ID NO: 3, wherein the amino acid at position 15 is substituted with or M,
Claim 8 is drawn to the protein according to claim 1, wherein said N-terminal capping module comprises an amino acid sequence that has at least 70% sequence identity with an amino acid sequence selected from the group consisting of SEQ ID NOs: 1 to 76.
The specification does not provide any structural attributes associated with the claimed protein.
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 what part of the sequence correlates with the required activity. The specification does not describe which portion of the protein is necessary to retain the desired activity (i.e. having an increased melting temperature as compared to an ankyrin repeat domain with a D at position 15).
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.
Based on the teachings of the specification, the protein can be any protein having at least 70% identity to any of SEQ ID NOs: 1-76, wherein D15 is substituted with I, A, V or M.
SEQ ID NOs: 1-76 are 30 amino acids long. Therefore, there are 13,154,400 (30x29x28x27x20) proteins encompassed by each of SEQ ID NOs: 1-76.
However, the specification fails to provide a representative number of examples for the claimed protein.
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.
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.
Claim 15 is 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 15 is drawn to the protein according to claim 1 wherein the Tm is increased by about 10 OC.
The MPEP 2173.05(b) states that “[I]n determining the range encompassed by the term "about" , one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). InW.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), the court held that a limitation defining the stretch rate of a plastic as "exceeding about 10% per second" is definite because infringement could clearly be assessed through the use of a stopwatch. However, in another case, the court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)”.
The instant specification does not define the term “about”. Thus, the range of melting temperatures encompassed by the term “about” is indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-8 and 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 has been interpreted as being drawn to “A protein comprising an ankyrin repeat domain, wherein said ankyrin repeat domain comprises an N- terminal capping module, wherein said N-terminal capping module comprises SEQ ID NO: 3, wherein the amino acid at position 15 is substituted with or M,
Claim 2 is drawn to the protein according to claim 1, wherein said N-terminal capping module has Q at the position corresponding to position 8 in SEQ ID NO: 3. Claim 1 requires position 8 of SEQ ID NO: 3 to be E. Therefore, claim 2 fails to include all the limitations of claim 1.
Similarly, claims 3-7 and 16, which allows for substitutions at positions 11, 19, 20, 22 and 23, fail to include all the limitations of claim 1.
Claim 8 is drawn to the protein according to claim 1, wherein said N-terminal capping module comprises an amino acid sequence that has at least 70% sequence identity with an amino acid sequence selected from the group consisting of SEQ ID NOs: 1 to 76. Claim 8 allows for the protein of claim 1 to have 70% sequence identity with any of SEQ ID NOs: 1-76. Thus, the claim is much broader than claim 1. As such, it fails to include all the limitations of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The rejection of claims 1 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Minter et al. is withdrawn in view of Applicant’s arguments.
Claim Rejections - 35 USC § 103
The rejection of claims 1, 7 and 12 under 35 U.S.C. 103 as being obvious over Minter et al. is withdrawn in view of Applicant’s arguments.
Allowable Subject Matter
SEQ ID NOs: 97-98 and 100-101 are free of the prior art.
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.
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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
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