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
Election/Restrictions
Applicant’s election without traverse of Group I and SEQ ID NO: 4 in the reply filed on 4/9/2026 is acknowledged.
Claims 7-14, 16-22 and 24-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/9/2026.
Status of the Claims
Claims 1-3, 7-14, 16-22 and 24-26 are pending in this application.
Claims 7-14, 16-22 and 24-26 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 1-3 are presently under consideration as being drawn to the elected species/invention.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 should be rewritten to recite “The composition of claim 1, wherein the Gal3BP polypeptide consists of SEQ ID NO: 4”. 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.
Claim 1 is 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 composition comprising a Galectin-3 (Gal3)-binding protein (Gal3BP) polypeptide, wherein the Gal3BP polypeptide sequence is at least 80% identical to SEQ ID NO: 4 or SEQ ID NO: 5.
When referring to the Gal3BP polypeptide, 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 what part of the sequence correlates with the required activity (i.e. to bind Galectin-3).
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 Gal3BP polypeptide can be any polypeptide having a sequence at least 80% identical to SEQ ID NO: 4 or SEQ ID NO: 5.
SEQ ID NO: 4 and SEQ ID NO: 5 are 15 amino acid long, therefore, even when considering only natural amino acids, one would end up with 54,600 (15x14x13x20) possible polypeptides.
However, the specification fails to provide a representative number of examples for the claimed polypeptide.
The specification teaches only 2 sequences that bind to Galectin-3 (i.e. SEQ ID NOs: 4-5).
The specification does not provide any teaching of what modifications can be made within the claimed sequence to allow for the claimed function.
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 2 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 2 is drawn to the composition of claim 1, wherein the Gal3BP polypeptide sequence is at least 95% identical to SEQ ID NO: 4. SEQ ID NO: 4 is 15 amino acid long. How can any sequence of 15 amino acid be 95% identical (wherein 0.75 amino acids differ) to another 15 amino acid long sequence (i.e. SEQ ID NO: 4)?
Therefore, the claim is indefinite.
Allowable Subject Matter
A polypeptide consisting of SEQ ID NO: 4 or SEQ ID NO: 5 is 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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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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