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 .
Claims Status
The remarks and amendments filed 04/07/2025 are acknowledged.
Claims 57 and 100-104 are pending.
Claims 1-56 and 58-99 are canceled.
Claims 57 and 100-101 are amended.
Claims 101-104 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/29/2024.
Therefore, claims 57 and 100 are under examination.
Withdrawn
The objection to claim 57 is withdrawn. Applicant has amended the claim to overcome the objection.
The rejections of claims 57-58 and 91-100 under 35 U.S.C. 112(b) are withdrawn. Applicant has amended claim 57 and canceled claim 99 to overcome these rejections.
The rejections of claims 57-58, 91-94, and 99-100 under 35 U.S.C. 112(a) are withdrawn. Applicant has amended claim 57 and canceled claim 98 to overcome the rejections.
The rejections of claims 57-58, 91, 95-97, and 100 under 35 U.S.C. 102 are withdrawn. Applicant has amended claim 57 to overcome the rejection.
Maintained Objections
Drawings
Regarding Figures 19B and 19C, color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Applicant submitted replacement drawings alleging that the amended drawings are in grayscale. However, the replacement drawings submitted on 05/01/2024 labeled as “Part 2” still show Figures 19B and 19C in color.
Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Maintained Rejections
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This rejection has been modified solely to address the amendments.
Claims 57 and 100 are rejected under 35 U.S.C. 103 as being unpatentable over Dimitrova et al., 2016 (01/24/2025 PTO-892) in view of UniProt, 2017 (01/24/2025 PTO-892), Dreher (WO2004035622; 01/24/2025 PTO-892) and Nimmerjahn et al., 2005 (01/24/2025 PTO-892).
Dimitrova teaches generating a chimeric protein (fusion protein) consisting of a CD300c extracellular domain and a Fc fragment of human IgG2 [page 5, first paragraph]. Dimitrova further teaches that the fusion proteins were re-suspended in PBS (phosphate buffered saline; pharmaceutically acceptable carrier) [page 10, fourth paragraph].
SEQ ID NO: 26 of the instant claim comprises a human CD300c protein (residues 1-155 of SEQ ID NO: 26) and a Fc fragment (residues 156-387) [see page 28, lines 16-22 of the specification].
However, Dimitrova does not specifically teach that the fusion protein comprises SEQ ID NO: 26.
UniProt teaches that the extracellular domain of hCD300c is residues 21-183 of the full sequence of hCD300c [page 4, see Features section].
Residues 29-183 of UniProt have 100% sequence identity to residues 1-155 of SEQ ID NO: 26 of the instant claim.
Dreher teaches a fusion protein of interleukin-15 and a Fc fragment [see page 1], wherein the Fc fragment can be murine IgG2a Fc fragment [see page 3, second to last paragraph]. Dreher further teaches the sequence of a murine IgG2a Fc fragment [see page 1].
The sequence of the mIgG2a Fc fragment of Dreher has 100% sequence identity to residues 156-387 of SEQ ID NO: 26 of the instant claim.
Nimmerjahn teaches that mouse IgG subclasses display a hierarchy of in vivo activities, with IgG2a and IgG2b showing the greatest protective and pathogenic properties [see page 41, left column, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the CD300c extracellular domain of the fusion protein of Dimitrova to specifically comprise the sequence of the hCD300c extracellular region as taught by UniProt. One would have been motivated to use the sequence of UniProt for the CD300c extracellular domain of Dimitrova because it is a known sequence in the art, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F). Further, since Dimitrova teaches the fusion protein consists of the CD300c extracellular region and UniProt teaches the sequence of the hCD300c extracellular region, this follows the logic of MPEP 2144.06 (II) which states it is prima facie obvious to substitute equivalents known for the same purpose.
It further would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Fc fragment of the fusion protein of Dimitrova to be the mIgG2a fragment of Dreher. One would have been motivated to modify the IgG2a Fc fragment of Dimitrova to be the mIgG2a fragment of Dreher because Dreher teaches that it can be used in fusion proteins and Nimmerjahn teaches that mouse IgG2a shows great protective and pathogenic properties. Additionally, it would have been obvious to use the sequence of Dreher for the Fc fragment of the fusion protein of Dimitrova because it is a known sequence in the art, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F).
Therefore, combining the teachings of Dimitrova, UniProt, Dreher, and Nimmerjahn, one skilled in the art would have arrived at a fusion molecule comprising the amino acid sequence of SEQ ID NO: 26 as instantly claimed. See sequence alignment below of residues 21-183 of UniProt combined with the IgG2a sequence of Dreher (top sequence) aligned to instantly claimed SEQ ID NO: 26 (bottom sequence).
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Response to Arguments
The rejections of claims 57 and 100 under 35 U.S.C. 103 are maintained. On pages 5-6 of the remarks, Applicant argues that administration of the fusion protein (i.e. SEQ ID NO: 26) attenuates graft-versus-host disease (GVHD) and autoimmune diseases, and that none of the cited art teaches or suggests that CD300c is a T cell co-inhibitory molecule or that the claimed fusion protein can attenuate GVHD and autoimmune diseases, and therefore, the claimed fusion protein has unexpected properties in view of the cited art. This is not found persuasive because in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e. that administration of the fusion protein (i.e. SEQ ID NO: 26) attenuates graft-versus-host disease (GVHD) and autoimmune diseases and that CD300c is a T cell co-inhibitory molecule) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant is reminded that the claims are directed to a fusion protein (i.e. a product) and not to a method of using the fusion protein.
Conclusion
No claims are allowed.
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.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675