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
Claim Status
Claims 1-3, 7-14, 16-22, 24 and 28-29 are pending. Claims 28-29 have been added. Claims 25-26 have been canceled. Claims 1-3 have been amended. Claims 1-3 and 28-29 are being examined in this application. In response to the restriction requirement, Applicants elected Group I and SEQ ID NO: 4. Claims 7-14, 16-22 and 24 are withdrawn as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112
The rejection of claim 2 under 35 USC 112(b) is withdrawn in view of the amendments to the claims.
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.
This rejection has been modified.
Claims 1-2 and 28 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 composition comprising a Galectin-3 (Gal3)-binding protein (Gal3BP) polypeptide, wherein the Gal3BP polypeptide consists of a sequence that is at least 85% 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% (or 90%) identical to SEQ ID NO: 4 or SEQ ID NO: 5.
SEQ ID NO: 4 and SEQ ID NO: 5 are 15 amino acids long, therefore, even when considering only natural amino acids, one would end up with 4,200 (15x14x20) possible polypeptides with 80% identity, or 300 (15x20) possible polypeptides with 90% identity. If one had to consider the thousands available non-natural amino acids, one would end up with millions.
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.
Response to Arguments
Applicant’s arguments filed on 8/21/2026 have been fully considered but they are not persuasive.
Applicant’s arguments are not persuasive because, as discussed in the rejection above, the claims cover millions of possible peptides.
The common sequence TLDLSRELSE is not being claimed. To overcome this rejection, Applicant should amend claim 1 as follows:
A composition comprising a Galectin-3 (Gal3)-binding protein (Gal3BP) polypeptide, wherein the Gal3BP polypeptide consists of a sequence that is at least 85% identical to SEQ ID NO: 4 or SEQ ID NO: 5, and wherein the sequence comprises the sequence TLDLSRELSE (note that a SEQ ID NO for the sequence TLDLSRELSE would be required).
Allowable Subject Matter
Claims 3 and 29 are 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.
Conclusion
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.
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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