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: 5 in the reply filed on 6/4/2026 is acknowledged.
Applicants elected species (i.e. SEQ ID NO: 5) was deemed to be free of the prior art. The search was extended to another species (see rejection under 35 U.S.C. 102(a)(1) below). As a result, claims 1-2, 35 and 54 have been examined and claims 10, 12-13, 15-16, 18, 20, 24, 26, 28, 30, 34, 36-37, 39, 41, 47 and 50 are withdrawn from consideration. While applicant’s elected species may read on one or more withdrawn claims, they have not been fully examined for patentability, and thus a determination of allowability cannot be made with respect to these claims at this time.
Status of the Claims
Claims 1-2, 10, 12-13, 15-16, 18, 20, 24, 26, 28, 30, 34-37, 39, 41, 47, 50 and 54 are pending in this application.
Claims 10, 12-13, 15-16, 18, 20, 24, 26, 28, 30, 34, 36-37, 39, 41, 47 and 50 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 1-2, 35 and 54 are presently under consideration as being drawn to the elected species/invention.
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 sequences presented in claims 10, 16 and 24, and in the specification (paras [0006], [0010] and [0012]) require sequence identifiers. 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.
Please direct all replies to the United States Patent and Trademark Office via one (1) of the following:
1. Electronically submitted through EFS-Bio (<http://www.uspto.gov/ebc/efs/downloads/documents.htm>, EFS Submission User Manual - ePave)
2. US Postal Service:
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Claim Rejections - 35 USC § 112
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 54 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 54 is drawn to a kit comprising a composition selected from the fusion protein of claim 1.
First of all, the word “selected” implies that at least two different things can be selected. Furthermore, it is unclear how a composition can be selected from a fusion protein.
To advance prosecution, the claim has been interpreted as being drawn to “A kit comprising a composition comprising the fusion protein of claim 1”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 35 and 54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 2016/0184391).
With respect to claims 1-2, Wang et al. teach a fusion protein comprising a complement receptor 2 (CR2) fragment linked to a complement inhibitory domain of complement factor H (CFH) (claim 2; para [0029]), wherein the CR2-FH molecule includes a CR2 portion including a CR2 or a fragment thereof and an FH portion including a FH or a fragment thereof (para [0023]).
Wang et al. also teach that the CR2-FH fusion protein comprises SEQ ID NO: 3 or a single chain antibody comprising SEQ ID NO:27 or SEQ ID NO:29 (claim 2).
The fusion protein of Wang et al. corresponds to the instantly claimed fusion protein D1-L1-D2-L2-D3, wherein D1 is a fragment of complement factor H; L1 is either absent, a covalent bond, or an amino acid sequence (i.e. any sequence separating D1 and D2); D2 is either absent, or comprises a single domain antibody (i.e. the VHH); L2 is either absent, a covalent bond, or an amino acid sequence (i.e. any sequence separating D2 and D3); and D3 is an integrin recognition domain comprising RGD (see amino acids at position 495-497 of SEQ ID NO: 3).
With respect to claim 35, Wang et al. teach pharmaceutical compositions comprising the fusion protein (para [0087]), wherein the pharmaceutical compositions comprise a lyoprotectant such as sucrose (i.e. a pharmaceutically acceptable carrier) ([para [0142]).
With respect claim 54, the only requirement of the kit is that it comprises a composition comprising the fusion protein. As discussed above, Wang et al. teach pharmaceutical compositions comprising the fusion protein and a lyoprotectant ([para [0142]).
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